Looking at the 2 year chart,
a breakout of the Symmetrical Triangle pattern.
Support @ $14.80
News Link
http://finance.yahoo.com/q/h?s=KERX
This one has been moving for the last 3 trading days,
forgot to do an update on it.
RSI is about to move through 70
Technicals
Record Price High
13-day EMA Cross Above 50-day EMA
Close Above the 50-day EMA
Record Price Break Out
Percentage Gainer
Last Price Quote is:
11.69%above 13-day EMA
12.27%above 50-day EMA
RS Rating: 92
Fundamentals
Key Data:
Market Cap (M): $590.27
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 11/07/2005
Last Analyst Rating: Overweight
AP
Keryx Trial Shows Positive Results
Thursday June 29, 11:27 am ET
Keryx Kidney Disease Treatment Shows Promising Results in Phase 2 Trial
NEW YORK (AP) -- Biotech company Keryx Biopharmaceuticals Inc. said Thursday its mid-stage trial of a kidney disease treatment showed positive results.
The company said the drug, Zerenex, was well tolerated, safe and effective in people with end-stage kidney disease at the optimum dose of 6 grams per day.
The patients were undergoing hemodialysis. None of the more than 100 patients in the 28-day study died or had serious adverse effects that could be definitely linked to Zerenex, the company said.
Keryx rose 36 cents, or 3 percent, to $13 in midday trading on the Nasdaq. In the past 52 weeks, the stock has traded between $12.27 and $19.35.
Keryx kidney drug shows promise in mid-stage trial
BOSTON, June 29 (Reuters) - Keryx Biopharmaceuticals Inc. (KERX.O: Quote, Profile, Research) said on Thursday that its experimental drug to treat end-stage kidney disease showed promise in a mid-stage clinical trial.
The company said the drug, Zerenex, had an acceptable safety profile, with no serious adverse events that investigators determined were definitely related to the drug.
Eyes on KERX
Volume: 1,083,018
Avg Vol (3m): 358,642
Technicals
Close Above the 13-day EMA
Last Price Quote is:
4.72%above 13-day EMA
-6.04%below 50-day EMA
RS Rating: 8
Fundamentals
Key Data:
Market Cap (M): $555.29
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 08/07/2006
Last Analyst Rating: Buy
AP
Ahead of the Bell: Keryx Biopharm
Thursday August 17, 9:29 am ET
Analyst Recommends Keryx Biopharmaceuticals, Expects Gains From Drug Sulonex
NEW YORK (AP) -- A Jefferies & Co. analyst recommended development-stage biotech company Keryx Biopharmaceuticals Inc. on Thursday, saying that the stock's price makes it a good buying opportunity.
Shares of Keryx are down 25 percent since the beginning of the year, but have increased 18 percent since hitting a year low of $9.53 on Monday.
Analyst Adam Walsh rebuffed investor concerns of competition and delays facing Sulonex, Keryx's diabetic kidney disease treatment candidate.
"We believe any perceived delay in Sulonex timelines is more a function of overly aggressive prior Street expectations rather than missed milestones," Walsh said.
Walsh reiterated a "Buy" rating on the shares with a $25 price target, applauding the company's "beefed up" management team and expecting Keryx to gain from Sulonex sales.
Walsh forecasts $36 million in Sulonex revenue in fiscal 2008, and sales to ramp up to $256 million in fiscal 2009.
Walsh noted that Sulonex is protected under a patent expiring in 2014, which Keryx said has an extension through at least 2017.
Walsh also expects Keryx to gain from hiring Ronald C. Renaud, Jr. as chief financial officer, who previously worked for JP Morgan Securities as a senior biotechnology research analyst.
Back above the 50-day MA with 3 white soldiers
Volume: 1,200,942
Avg Vol (3m): 456,654
52wk Range: 9.53 - 19.35
Technicals
Close Above the 13-day EMA
Percentage Gainer
Last Price Quote is:
15.35%above 13-day EMA
1.40%above 50-day EMA
RS Rating: 12
Fundamentals
Key Data:
Market Cap (M): $422.50
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 11/09/2006
Last Analyst Rating: Buy
Hi setravis...Great find :)
I believe KERX is ready for a new downtrend...
Technical analysis :
1. Chart pattern : Symmetrical Continuation Triangle (Bearish)
2. Trend : DOWNTREND..the end of the pullback.
3. Volume : Low on the last minor uptrend
4. Candlestick : a doji is appeared at the end of pullback.
Close at 13.00
target at 10.00
Stop loss at 14.44
JMHO....I think this uptrend is going to continue.
In my view looks like we have a Head and Shoulders Bottom ,formed.
52wk Range: 9.53 - 19.35
Volume: 473,753
Avg Vol (3m): 423,918
Technicals
Last Price Quote is:
2.28%above 13-day EMA
5.44%above 50-day EMA
RS Rating: 60
Fundamentals
Key Data:
Market Cap (M): $561.39
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 11/09/2006
Last Analyst Rating: Buy
No time for comments.......
Will leave the end of the day chart
Yesterday's news.......
NEW YORK, Oct 04, 2006 /PRNewswire-FirstCall via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX, Trade) today announced that it has entered into an exclusive license agreement with Kyowa Hakko Kogyo Co., Ltd. (Kyowa Hakko), of Tokyo, Japan, for the worldwide development and commercialization rights, excluding Japan, to UCN-01 (7-hydroxystaurosporine). UCN-01 is a novel multi-kinase inhibitor for the treatment of cancer which, in preclinical models, has demonstrated a synergistic effect with agents inhibiting the PI3K pathway, including perifosine. UCN-01 is currently in several Phase II clinical trials both as a single agent and in combination with other anticancer agents which are being conducted under the direction and sponsorship of the National Cancer Institute. In accordance with the terms of the agreement, Keryx will make up-front and milestone payments as well as pay royalties on product sales.
Commenting on the in-licensing of UCN-01, I. Craig Henderson, MD, the Company's President, stated "We are excited about this drug because it targets some of the most interesting pathways involved in the propagation and survival of cancer cells and complements our ongoing program with KRX-0401 (perifosine)."
ABOUT UCN-01
UCN-01 is an anticancer drug that belongs to the family of drugs called staurosporine analogs which have demonstrated an ability to inhibit multiple kinases involved in cell-cycle progression and apoptosis, including Chk-1 and PDK1. In pre-clinical studies, UCN-01 has demonstrated synergistic effect with DNA-damaging agents including chemotherapy and radiation therapy. In-vitro, UCN-01 has been shown to be synergistic with agents affecting the PI3-K pathway including perifosine and mTOR inhibitors. In clinical trials, as reported by investigators at the National Cancer Institute, durable single-agent responses have been seen in patients with anaplastic large-cell lymphoma.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx's lead compound under development is Sulonex(TM), previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase III and Phase IV clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, inorganic, iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase II clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end-stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401 (perifosine), a novel, first-in-class, oral modulator of Akt, a pathway associated with tumor survival and growth, and other important signal transduction pathways. KRX-0401 (perifosine) is currently in Phase II clinical development for multiple tumor types. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Contact:
Ronald C. Renaud, Jr. Thomas Redington
Chief Financial Officer 203 222-7399
212 531-5965 212 926-1733
[email protected] [email protected] SOURCE Keryx Biopharmaceuticals, Inc.
Ronald C. Renaud, Jr., Keryx Biopharmaceuticals, Inc. +1-212-531-5965,
[email protected]; Thomas Redington, +1-203-222-7399, +1-212-926-1733,
[email protected] http://www.prnewswire.com
Copyright (C) 2006 PR Newswire. All rights reserved ********************************************************************** As of Saturday, 09-30-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 09-26-2006 for KERX @ $12.50. For more information on Comtex SmarTrend? Alert, contact your market data provider or go to CSTADirect.com SmarTrend is a registered trademark of Comtex News Network, Inc. Copyright ? 2004-2006 Comtex News Network, Inc. All rights reserved.
Good here.. macd about to cross center,
look for strong volume pushing this through $17 to $19
Technicals
Close Above the 50-day MA
Close Above the 13-day MA
Last Price Quote is:
7.12%above 13-day MA
6.00%above 50-day MA
RS Rating: 18
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 11/09/2006
Last Analyst Rating: Buy
52wk Range: 9.53 - 19.35
Volume: 597,388
Avg Vol (3m): 409,460
Support @ $12.61...11.65...9.60
Resistance @ $13.88...14.81...17.70
:)
uptrend wants to continue...
Has also formed a Symmetrical Triangle (continuation) Pattern.
JMHO, I do think a nice move is coming.
Closing in on the 200-day MA
52wk Range: 9.53 - 19.35
Volume: 368,744
Avg Vol (3m): 421,622
Technicals
Last Price Quote is:
7.24%above 13-day EMA
9.32%above 50-day EMA
RS Rating: 78
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 11/09/2006
Last Analyst Rating: Buy
Moving steady on up. ;)
Head and Shoulders Bottom (Reversal) Pattern and a,
Symmetrical Triangle (Continuation) Pattern
Biotechnology & Drugs (6 new highs today)
52wk Range: 9.53 - 19.35
Volume: 538,856
Avg Vol (3m): 420,705
Technicals
MACD is Bullish
Stochastic is Bullish
Last Price Quote is:
9.65%above 13-day MA
12.52%above 50-day MA
RS Rating: 82
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 11/09/2006
Last Analyst Rating: Buy
Press Release Source: Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Announces Upcoming Corporate Presentations
Friday November 10, 2:33 pm ET
Presentations at Bear Stearns 2006 SMid-Cap Investor Conference and 2006 Annual Stanford Growth Conference to take place on Tuesday, November 14th
NEW YORK, Nov. 10 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX - News) today announced that the Company will be presenting at the Bear Stearns SMid-Cap Investor Conference and the 2006 Annual Stanford Growth Conference. Both presentations will take place in New York City on Tuesday, November 14, 2006.
Bear Stearns 2006 SMid-Cap Investor Conference: Corporate presentation will be delivered by Michael S. Weiss, the Company's Chairman and Chief Executive Officer, at 2:00 PM Eastern Time at the Bear Stearns World Headquarters. A live audio webcast of Mr. Weiss' presentation will be available at http://cc.talkpoint.com/BEAR002/111406a_cy/?entity=keryx . An archived version of the webcast will be available following the conclusion of the live presentation.
2006 Annual Stanford Growth Conference: Corporate presentation will be delivered by Ronald C. Renaud, Jr., the Company's Chief Financial Officer, at 8:30 AM ET at the St. Regis Hotel. A live audio webcast of Mr. Renaud's presentation will be available at http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=KERX&item_id=1417466. An archived version of the webcast will be available following the conclusion of the live presentation.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx's lead compound under development is Sulonex(TM), previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase III and Phase IV clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, inorganic, iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase II clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end-stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401, a novel, first-in-class, oral modulator of Akt, a pathway associated with tumor survival and growth, and other important signal transduction pathways. KRX-0401 is currently in Phase II clinical development for multiple tumor types. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Contact:
Ronald C. Renaud, Jr.
Chief Financial Officer
212 531-5965
[email protected]--------------------------------------------------------------------------------
Source: Keryx Biopharmaceuticals, Inc.
A Fibonacci 61.8% retrace, looking for the bounce back to the upside.
Support @ $12.86...12.47...12.00
Resistance @ $13.50...13.99...14.66
52wk Range: 9.53 - 19.35
Volume: 287,476
Avg Vol (3m): 385,885
Technicals
Stochastic is Bullish
Last Price Quote is:
-2.52%below 13-day MA
-0.69%below 50-day MA
RS Rating: 90
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 03/07/2007
Last Analyst Rating: Buy
Hello..... anybody out there ?
52wk Range: 9.53 - 19.35
Volume: 710,901
Avg Vol (3m): 380,524
Technicals
Percentage Gainer
Last Price Quote is:
4.31%above 13-day MA
5.55%above 50-day MA
RS Rating: 94
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 03/07/2007
Last Analyst Rating: Buy
No more time ....
Today's closing chart
Technicals
Close Above the 13-day EMA
Last Price Quote is:
1.90%above 13-day EMA
4.76%above 50-day EMA
RS Rating: 62
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 03/07/2007
Last Analyst Rating: Buy
Back above the 50/200-day MA
Looks to be closing in on a Golden Cross.......
52wk Range: 9.53 - 19.35
Volume: 976,671
Avg Vol (3m): 383,982
Technicals
Close Above the 50-day MA
Stochastic - Bullish
Percentage Gainer
Last Price Quote is:
2.26%above 13-day MA
4.14%above 50-day MA
RS Rating: 73
Fundamentals
Key Data:
Market Cap (M): $545.41
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 03/07/2007
Last Analyst Rating: Buy
TOP STORIES.......
Keryx Enters Into Licensing Agreement
With Japan Tobacco and Torii Pharmaceutical
Keryx Biopharmaceuticals (KERX) announced that it entered into a licensing
agreement with Japan Tobacco Inc. and Torii Pharmaceutical
Co., Ltd.,JT's pharmaceutical business subsidiary, under which JT and
Torii will hold the exclusive rights for the development and commercialization
of its hyperphosphatemia drug in Japan. The drug is currently in
phase II clinical development in the United States under the name of
"Zerenex(TM). The licensing arrangement calls for JT and Torii to pay
to Keryx up to $100 million in up-front license fees and payments upon
the achievement of pre-specified milestones, including up to $20 million
in up- front payments and near-term milestones. In addition, upon commercialization,
JT and Torii will make royalty payments to Keryx on net
sales of the drug in Japan. JT and Torii will be responsible for the future
development and commercialization costs in Japan.
REPORTS DATA SAFETY MONITORING BOARD EVALUATION: Keryx Biopharmaceuticals
(KERX) announced that the Independent Data Safety Monitoring Committee (DSMC) responsible
for monitoring Sulonex(TM) (sulodexide oral gelcaps), the Company's lead drug candidate
under development as a treatment for diabetic nephropathy, recently met to evaluate the data
from the ongoing Phase 3 trial. Following a complete review of all available safety and efficacy
data, the DSMC found no cogent reason to recommend alteration or termination of the Phase 3
trial. The DSMC raised no safety concerns regarding Sulonex or the trial.
updated chart look...
BreakOut...
Look for strong volume to push this on up.
The Golden Cross...Buy on Pull backs.
52wk Range: 0.09 - 0.57
Volume: 12,348,229
Avg Vol (3m): 1,063,190
Technicals
Most Actives
Percentage Gainer
Last Price Quote is:
99.25%above 13-day MA
169.94%above 50-day MA
RS Rating: 99
Fundamentals
Key Data:
Market Cap (M): $20.12
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 08/07/2009
Last Analyst Rating: Accumulate
Press Release Source: Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
On Monday June 1, 2009, 8:30 am EDT
KRX-0401 + Capecitabine More Than Doubles Time to Progression and Overall Response Rate as well as Extends Overall Survival vs. Capecitabine + Placebo in Patients with 2nd or 3rd Line Metastatic Colon Cancer
NEW YORK, June 1 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX - News) yesterday announced data on the clinical activity of KRX-0401 (perifosine), the Company's Akt-inhibitor for cancer, in combination with capecitabine as a treatment for advanced colon cancer. Abstract #4081, entitled, "Randomized phase II study of perifosine in combination with capecitabine versus capecitabine alone in patients with second- or third-line metastatic colon cancer," was presented yesterday in a poster during the Gastrointestinal Cancer -- Colorectal session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Orlando, Florida.
In this randomized, double-blind, placebo-controlled study conducted at 11 centers across the United States, patients with 2nd or 3rd line metastatic colon cancer were randomized to receive capecitabine (Xeloda®), an approved drug for metastatic colon cancer, at a dose of 825 mg/m2 BID (total daily dose of 1650 mg/m2) on days 1-14 every 21 days, plus either perifosine or placebo at 50 mg daily. Treatment was continued until progression. The study enrolled a total of 38 patients, of which 35 patients were evaluable for response (20 patients on the capecitabine + perifosine arm and 15 patients on the capecitabine + placebo arm). The three patients not evaluable for response were all in the capecitabine + placebo arm; 2 patients were inevaluable due to toxicity (days 14, 46) and 1 patient was inevaluable due to a new malignancy on day 6.
The median prior treatment regimens was two, with prior treatment regimens as follows: 91% of the patients received prior FOLFIRI (Irinotecan + 5FU + Leucovorin); 74% prior FOLFOX (Oxaliplatin + 5FU + Leucovorin); 63% were previously treated with both FOLFIRI and FOLFOX; 77% received prior Avastin®; and 43% prior Erbitux®. Prior treatment with single agent capecitabine was excluded.
The primary endpoints of this study were to measure 1) Time to Progression (TTP); 2) Overall Response Rate (ORR), defined as the percentage of patients achieving a Complete Response (CR) or Partial Response (PR) by RECIST, and 3) Clinical Benefit Rate (CBR) defined as the percentage of patients on treatment for greater than three months with at least stable disease. Safety of perifosine + capecitabine vs. capecitabine + placebo in this patient population was evaluated as a secondary endpoint. Perifosine in combination with capecitabine was well tolerated with hand/foot syndrome (14%) and anemia (11%) as the highest reported grade 3/4 adverse events.
Best response and median time to progression of capecitabine + perifosine vs. capecitabine + placebo were as follows:
Group SD > 12
N CR PR ORR Wks CBR Median TTP
N(%) N(%) N(%) N(%) N(%) (wks)
Capecitabine 20 1 3 4 11 15 28.9 weeks
+ Perifosine (5%) (15%) (20%) (55%) (75%) {95% CI (13, 48.1)}
Capecitabine
+ Placebo 15 0 1 1 5 6 11 weeks
(7%) (7%) (33%) (40%) {95% CI (9, 15.9)}
Perifosine + capecitabine more than doubled time to progression vs. capecitabine + placebo with a statistically significant p-value = 0.0006. In addition, perifosine + capecitabine more than doubled the ORR and almost doubled the Clinical Benefit Rate vs. capecitabine + placebo.
Although not a primary endpoint in the study, overall survival was analyzed with results as follows:
Group Median Overall Survival* % change
(months)
Capecitabine + Perifosine 22 {95% CI (12.1, NR)} 26% Increase**
Capecitabine + Placebo 16.3 {95% CI (5.3, 17.1)}
* Survival calculated from date of randomization until date of death
from any cause, whether or not additional therapies were received
after removal from treatment
** As of May 2009, median overall survival in the perifosine +
capecitabine patient group is ongoing with 10 of the 20 patients in
this arm still alive.
Dr. Howard Burris, Chief Medical Officer and Director of Drug Development for the Sarah Cannon Research Institute, Nashville TN, an investigator involved in the Keryx-sponsored perifosine clinical program since 2004, remarked, "The results demonstrate that the addition of perifosine to capecitabine more than doubled time to progression and response rates, along with extending survival vs. capecitabine alone. Although not a large sample size, the data here is very interesting and next steps should be considered."
Ron Bentsur, Chief Executive Officer of Keryx, commented, "Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine and capecitabine, two oral agents, appears to demonstrate superior clinical benefit over capecitabine alone in this advanced patient population. We will now explore plans to move this program forward in patients with advanced colorectal cancer." Mr. Bentsur added, "We wish to thank all the study investigators for their dedication to this clinical trial."
A copy of abstract #4081 is currently available and can be viewed on-line through the ASCO website: http://www.asco.org/. A copy of the poster may be obtained by contacting the Company.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS - News; TSX: AEZ - News) in the United States, Canada and Mexico.
About Colon Cancer
According to the American Cancer Society, not counting skin cancers, colorectal cancer is the third most common cancer diagnosed in the United States. It is estimated that 106,100 people will be diagnosed with colon cancer, 40,870 people will be diagnosed with rectal cancer and approximately 50,000 deaths will be attributable to some form of colorectal cancer in 2009. Surgery is often the main treatment for early stage colon cancer. When colon cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colon cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have shown to increase survival rates for some stages of colorectal cancer. Currently, there are seven approved drugs for patients with metastatic colorectal cancer: 5-FU, capecitabine (Xeloda®), irinotecan (Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®), cetuximab (Erbitux®), and panitumumab (Vectibix®). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM)(ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also actively engages in business development activities that include seeking strategic relationships for its product candidates and for the Company, as well as evaluating compounds and companies for in-licensing or acquisition. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for KRX-0401, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete clinical trials for KRX-0401; our ability to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.keryx.com. The information in our website and in the American Society of Clinical Oncology's website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
E-mail:
[email protected]
Quote from: setravis on May 27, 2009, 04:25:55 PM
BreakOut...
Look for strong volume to push this on up.
The Golden Cross...Buy on Pull backs.
;) :D ;D
Runaway Gaps...
Runaway gaps are also called measuring gaps, and are best described as gaps that are caused by increased interest in the stock. For runaway gaps to the upside, it usually represents traders who did not get in during the initial move of the up trend and while waiting for a retracement in price, decided it was not going to happen. Increased buying interest happens all of a sudden, and the price gaps above the previous day's close. This type of runaway gap represents an almost panic state in traders. Also, a good uptrend can have runaway gaps caused by significant news events that cause new interest in the stock. In the chart below, note the significant increase in volume during and after the runaway gap.
Runaway gaps can also happen in downtrends. This usually represents increased liquidation of that stock by traders and buyers who are standing on the sidelines. These can become very serious as those who are holding onto the stock will eventually panic and sell – but sell to whom? The price has to continue to drop and gap down to find buyers. Not a good situation.
The term measuring gap is also used for runaway gaps. This is an interpretation that is hard to find examples for, but it is a way of helping one decide how much longer a trend will last. The theory is that the measuring gap will occur in the middle, or half way, through the move.
Sometimes, the futures market will have runaway gaps that are caused by trading limits imposed by the exchanges. Getting caught on the wrong side of the trend when you have these limit moves in futures can be horrifying. The good news is that you can also be on the right side of them. These are not common occurrences in the futures market despite all the wrong information being touted by those who do not understand it, and are only repeating something they read from an uninformed reporter.
52wk Range: 0.09 - 0.82
Volume: 19,508,118
Avg Vol (3m): 1,453,000
Technicals
Most Actives
Percentage Gainer
Last Price Quote is:
169.41%above 13-day MA
302.61%above 50-day MA
RS Rating: 99
Fundamentals
Key Data:
Market Cap (M): $33.53
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 08/07/2009
Last Analyst Rating: Accumulate
BOOYA...
Biopharmaceuticals(KERX) seems like the big winner so far, the only ASCO stock up significantly....
Keryx Pharmaceuticals
Keryx blew up in March 2008 when its lead drug for diabetic nephropathy failed a pivotal phase III study. The setback sent the company's stock plunging below $1 where it has stayed ever since. Money became tight and the company was forced to restructure operations and cut back on the development of two remaining drugs. A new CEO took over Keryx's reins in May.
This weekend, Keryx presented mid-stage data from one of those remaining pipeline drugs. Perifosine, or KRX-0401, is an oral anti-cancer drug that targets the AKT pathway in cells, which when activated, promotes cell survival and resistance to chemotherapy. High levels of AKT are seen in many types of cancer and are often correlated with poor prognosis.
How it has performed since it was placed on my Watch List...
Keryx shares jump on positive Zerenex study
Keryx Biopharmaceuticals shares jump as kidney disease drug meets midstage study goal
On Monday June 8, 2009, 11:04 am EDT
NEW YORK (AP) -- Shares of Keryx Biopharmaceuticals Inc. jumped Monday after the company reported positive midstage safety results for its kidney disease drug.
The stock rose 34 cents, or 31.6 percent, to $1.42 in morning trading. Shares earlier reached $1.58, their highest point in the past 52 weeks.
The company is developing Zerenex as a treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage kidney disease. Those patients are on hemodialysis, which is used to remove waste products from the blood.
The drug candidate met its key safety goals in the study. Meanwhile, the midstage study results suggested that the drug is effective in regulating serum phosphorous levels, though the study is not designed to test for effectiveness.
Keryx is now in the process of developing a late-stage development program for the drug and is consulting with the Food and Drug Administration. The regulatory agency has already said the current studies are adequate to support late-stage clinical trials.
NEW YORK, June 8, 2009 /PRNewswire-FirstCall via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX, Trade) today announced results of the Phase 2 study of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on thrice weekly hemodialysis. The study was a multicenter, open-label clinical trial, which enrolled 55 patients. The primary objective of this study was to assess the tolerability and safety of Zerenex (ferric citrate) with doses ranging from approximately 1 gram per day to 12 grams per day.
The top line efficacy and safety results from this Phase 2 study were submitted to the FDA, and discussed at a recent face to face meeting with the Division of Cardiovascular and Renal Drug Products. The FDA also reviewed the final reports for the 90-day rat and 16-week canine toxicology studies. The FDA indicated that the results of the Phase 2 study and the toxicology studies were adequate to support entry into a Phase 3 program. Keryx is in the process of finalizing the Phase 3 program in consultation with the FDA.
The FDA also reviewed the protocols for the ongoing chronic toxicology studies (6-month rat and 42-week canine), which can be completed after the Phase 3 program has begun.
In the first part of the Phase 2 study, 34 ESRD patients who were taking approximately 6 to 15 tablets/capsules per day of calcium acetate, calcium carbonate, lanthanum carbonate or sevelamer hydrochloride or any combination of these agents were eligible for enrollment and immediately switched to a starting dose of 4.5 grams per day of Zerenex (ferric citrate). In the second part of the study, 21 ESRD patients who were taking > 12 tablets/capsules per day of calcium acetate, calcium carbonate, lanthanum carbonate or sevelamer hydrochloride or any combination of these agents were eligible for enrollment and immediately switched to a starting dose of 6.0 grams per day of Zerenex (ferric citrate). Patients were treated with Zerenex (ferric citrate) for four weeks and were titrated weekly to achieve and maintain normal serum phosphorus levels, between 3.5 to 5.5 mg/dL, the therapeutic goal.
Although designed primarily as a safety study, key efficacy parameters were evaluated, with results as follows:
At baseline:
-- Baseline mean + standard deviation (SD) serum phosphorus was
approximately 5.9 + 1.5 mg/dL immediately prior to the switch to Zerenex
(ferric citrate);
-- The average daily dose of PhosLo(R) (calcium acetate) was 6.9 grams per
day and for Renagel(R) (sevelamer hydrochloride) was 9.9 grams per day,
for patients not on combination therapy prior to the switch to Zerenex
(ferric citrate).
Following the treatment period (four weeks on Zerenex):
-- At the end of the treatment period (after four weeks on Zerenex) the
mean + SD serum phosphorus was approximately 5.4 + 1.3 mg/dL;
-- The average daily dose of Zerenex (ferric citrate) at the end of four
weeks of treatment was 6.8 grams per day.
In the subset of patients who had a serum phosphorus above the normal range (> 5.5 mg/dL) immediately prior to the switch to Zerenex (n = 29), the mean (SD) baseline serum phosphorus was 7.0 (1.1) mg/dL, and at the end of treatment with Zerenex the mean (SD) serum phosphorus was 5.6 (1.6) mg/dL.
In the Phase 2 study, there were four serious adverse events which were deemed unrelated to Zerenex. Darkened stool was reported in the study and was associated with the presence of iron in the gastrointestinal tract. With the exception of the reporting of darkened stool as an (asymptomatic) adverse event, the gastrointestinal adverse event profile was similar in incidence to that reported for other currently marketed phosphate binders. There was no increase in serum calcium noted in the study.
Dr. Julia Lewis, Professor of Medicine at Vanderbilt University, the Principal Investigator in the study, commented, "This study, as well as earlier studies, suggest that Zerenex is an effective, tolerated phosphate binder that will potentially make a significant clinical addition to treating the important universally present problem of hyperphosphatemia in patients with end-stage renal disease."
Ron Bentsur, Chief Executive Officer of Keryx, stated, "The promising safety and efficacy profile of Zerenex indicates that there is significant market potential for the drug in the phosphate binder space." Mr. Bentsur continued, "We're excited to have two late stage clinical drug candidates, Zerenex and KRX-0401 (perifosine), both with compelling Phase 2 data."
About Hyperphosphatemia
In the United States, according to data from the U.S. Renal Data System, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 by 2020. The majority of ESRD patients, over 350,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an effective and safe treatment in lowering and/or maintaining normal serum phosphorus levels in patients with ESRD and hyperphosphatemia.
Sales of phosphate binders to treat hyperphosphatemia in ESRD patients in the U.S. were approximately $600 million in 2007, and has grown in excess of 20% per annum over the last five years.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also actively engages in business development activities that include seeking strategic relationships for its product candidates and for the Company, as well as evaluating compounds and companies for in-licensing or acquisition. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for Zerenex and KRX-0401, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete clinical trials for Zerenex and KRX-0401; our ability to meet anticipated development timelines for Zerenex and KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
E-mail:
[email protected] SOURCE Keryx Biopharmaceuticals, Inc.
http://www.keryx.com
Copyright (C) 2009 PR Newswire. All rights reserved
Keryx Reports Positive Phase 2 Drug Study; Shares Jump
Large Opportunity in Small Cap Stocks
At the last quarterly report, the company reported swung to posting a profit. They have 15 million dollars in CASH and have basically ruled out any possibility of bankruptcy. Why do you think we entered it after this filing!
Stockwolf.com Selects KERX as Possible 5-bagger
52wk Range: 0.09 - 1.45
Volume: 11,704,437
Avg Vol (3m): 1,965,050
Technicals
Most Actives
Percentage Gainer
Last Price Quote is:
57.88%above 13-day MA
184.28%above 50-day MA
RS Rating: 99
Fundamentals
Key Data:
Market Cap (M): $51.73
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 08/07/2009
Last Analyst Rating: Accumulate
NEW YORK, June 17, 2009 /PRNewswire-FirstCall via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX, Trade) announced today that the Company has received a letter from The NASDAQ Stock Market confirming that it has regained compliance with the minimum bid price requirement for continued listing on The NASDAQ Capital Market under Listing Rule 5550(a)(2) and that the matter is now closed.
The Company also received a letter from the NASDAQ Listing Qualifications Hearings Panel confirming that it has demonstrated a market value of listed securities over the required minimum of $35 million for 10 consecutive trading days, for continued listing on The NASDAQ Capital Market under Listing Rule 5550(b)(2), and that the Panel has determined to continue the listing of the Company's securities on The NASDAQ Stock Market.
The Company's stock continues to be listed on the NASDAQ Capital Market and its ticker symbol of KERX remains unchanged.
"We are pleased to have regained compliance with all the NASDAQ Capital Market listing requirements," stated Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals. "We believe this represents an important step in building value for our stockholders."
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM)(ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also actively engages in business development activities that include seeking strategic relationships for its product candidates, as well as evaluating compounds and companies for in-licensing or acquisition. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: There can be no assurance that the Company will be able to satisfy the listing requirements of The NASDAQ Capital Market in the future or that the Company's stock will not be affected by other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
E-mail:
[email protected] SOURCE Keryx Biopharmaceuticals, Inc.
http://www.keryx.com
Copyright (C) 2009 PR Newswire. All rights reserved
KERX looks ready to explode !
Insiders buying...not selling... ;)
52wk Range: 0.09 - 1.58
Volume: 1,950,166
Avg Vol (3m): 2,309,950
Technicals
Stochastic - Bullish
Percentage Gainer
Last Price Quote is:
-0.15%below 13-day MA
53.50%above 50-day MA
RS Rating: 99
Fundamentals
Key Data:
Market Cap (M): $54.60
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 08/07/2009
Last Analyst Rating: Accumulate
New research note from Brean Murray Carret & Co, with a $3 price target:
(http://img117.imageshack.us/img117/695/nflxcn8.th.png) (http://www.3stocksonfire.org/trading/index.php?action=dlattach;attach=48751)
rolling on...
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
Press Release Source: Keryx Biopharmaceuticals, Inc. On Monday April 5, 2010, 8:30 am EDT
NEW YORK, April 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX - News) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda®) versus placebo in combination with capecitabine in patients with refractory advanced colorectal cancer is expected to commence in the second quarter of 2010 under a Special Protocol Assessment (SPA) with the FDA.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We believe that this Fast Track designation adds substantial value to perifosine's development in refractory advanced colorectal cancer. We intend to initiate the Phase 3 colorectal study in the second quarter, with study completion expected in the second half of 2011. With the SPA and Fast Track designation in place, we believe that commercialization of perifosine in this indication could potentially commence by mid-2012."
In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track designation granted.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
About KRX-0401 (perifosine)
KRX-0401 (perifosine) is a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of KRX-0401 on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with metastatic/advanced colorectal cancer. Currently, there are seven approved drugs for patients with metastatic/advanced colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda®), irinotecan (Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®), cetuximab (Erbitux®), and panitumumab (Vectibix®). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Bevacizumab, a VEGF monoclonal antibody, is commonly administered with chemotherapy. Typically, patients who fail 5-FU, oxaliplatin, irinotecan, and bevacizumab-containing therapies, and who have wild-type KRAS status receive EGFR monoclonal antibody therapy with either cetuximab or panitumumab. Once patients progress on these agents, there are no further standard treatment options.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma, with a Phase 3 trial in refractory advanced colorectal cancer, under SPA, pending commencement, and in Phase 2 clinical development for several other tumor types. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 trials will not coincide with the data analyses from the Phase 1 and Phase 2 clinical trials previously reported by the Company; the risk that fast track designation and priority review may not result in earlier approval; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
E-mail:
[email protected]
UPDATE 2-Aeterna cancer drug gets US fast track designation
* Phase 3 trial for perifosine to begin this quarter
* Drug in development with Keryx
* Trial to end in 2011; U.S. launch expected for 2012
* Aeterna shares jump 27.5 pct (Adds share price and analyst's comments)
TORONTO, April 5 (Reuters) - Canadian drugmaker Aeterna Zentaris (AEZ.TO) and U.S. partner Keryx Biopharmaceuticals (KERX.O) said on Monday that U.S. regulators have granted their colorectal cancer treatment fast track approval, sending the shares of the two companies soaring.
The companies said they would begin a phase 3 trial for the treatment, called perifosine, or KRX-0401, sometime this quarter. The trial is expected to end in 2011, followed by a U.S. launch for perifosine in 2012.
Aeterna shares, which plunged 75 percent last year on disappointing trial results for one of its products, were up 27.5 percent at C$1.02 on the Toronto Stock Exchange on Monday morning. The shares of Keryx were up 22.2 percent at $3.35 on Nasdaq.
"This definitely shortens the timelines to potential approval of the drug," said Neil Maruoka, an analyst at Canaccord Adams.
Fast track approval is reserved for new treatments being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States. The designation grants the drug developers seven years of market exclusivity.
Aeterna is developing the drug with partner and licensee Keryx in the United States, Canada and Mexico.
Last month, European health regulators granted perifosine orphan drug status for the treatment of blood cancer. The drug received a similar designation from the U.S. Food and Drug Administration last year. ($1=$1.004 Canadian) (Reporting by Scott Anderson; editing by Peter Galloway)
Keryx cancer treatment gets faster FDA review
Keryx, AEterna Zentaris cancer treatment receives faster FDA review
On Monday April 5, 2010, 10:43 am EDT
NEW YORK (AP) -- Keryx Biopharmaceuticals Inc. and AEterna Zentaris Inc. said Monday regulators have given a "fast track" designation to the drug candidate perifosine as a potential treatment for refractory advanced colorectal cancer.
The designation allows the Food and Drug Administration to conduct a faster review of a potential treatment intended for a serious or life-threatening disease. Drug developers can submit their applications to the FDA piece by piece instead of having to file all the paperwork at once.
Keryx, which is based in New York, and AEterna Zentaris, a Canadian company, are partnering on perifosine in North America. AEterna Zentaris has the rights to the drug in the rest of the world excluding South Korea.
A late-stage trial of the drug will start this quarter and be completed in the second half of 2011, Keryx said in a statement.
In December, perifosine received a fast-track review designation as a potential treatment for multiple myeloma.
Perifosine also has orphan drug status, which is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.
Keryx shares climbed 67 cents, or 24 percent, to $3.41 in Monday morning trading. AEterna Zentaris stock rose 20 cents, or almost 25 percent, to $1.
April 5, 2010, 1:06 p.m. EDT
Keryx, Aeterna rocket on FDA move
BOSTON (MarketWatch) - Partners Keryx Biopharmaceuticals and Aeterna Zentaris saw their respective shares rocket Monday on hopes that their new colorectal cancer therapy perifosine could be out on the market by mid-2012.
Shares of Keryx /quotes/comstock/15*!kerx/quotes/nls/kerx (KERX 3.35, +0.61, +22.39%) soared 20% to $3.43, after hitting a 52-week high of $3.56 earlier in the day. Aeterna /quotes/comstock/15*!aezs/quotes/nls/aezs (AEZS 0.96, +0.16, +19.99%) shares, meanwhile, were trading at $1.01, up 26%.
Early Monday, Keryx said that the U.S. Food and Drug Administration had granted perifosine "fast-track" status, an administrative designation that generally helps expedite the drug-approval process.
Keryx said that it plans to initiate a key Phase III clinical trial of the product in the second quarter. The trial should be completed during the second half of 2011. The product is also in Phase III testing for the blood cancer multiple myeloma.
Keryx added that if all goes well, perifosine could be on the market by mid-2012. Keryx holds the license for the product's North American marketing rights, while Aeterna has retained rights to the product for most other global regions.
Keryx currently has no products on the market. Quebec-based Aeterna markets a hormone medication for in vitro fertilization procedures called Cetrotide.
Val Brickates Kennedy is a reporter for MarketWatch in Boston.
Monday, April 05, 2010
Keryx Gets Fast-Track Status for Perifosine
FOXBusiness Medical company Keryx (KERX: 3.36, 0.62, 22.63%) announced Monday that the U.S. Food and Drug Administration granted its cancer drug perifosine status as a "fast-track" drug, which can mean an expedited approval into the marketplace.
The shares soared 23% to $3.38.
Keryx said the drug's Phase III clinical trials will begin in the second quarter, and will be completed in the second half of 2011. Given the expedited status from the FDA, perifosine could be on the market as early as 2012.
The drug's licensing is held by Keryx in North America, and by Aeterna (AEZS: 0.9566, 0.1565, 19.56%) in other parts of the world.
Biotech Stocks
April 5, 2010, 3:18 p.m. EDT
Keryx, Aeterna soar on FDA 'fast-track' designation
MarketWatch
BOSTON (MarketWatch) -- Keryx Biopharmacueticals scored solid gains Monday, with the small-cap's shares soaring as U.S. regulators granted "fast-track" status to the company's oncology drug candidate perifosine.
The designation means that Keryx /quotes/comstock/15*!kerx/quotes/nls/kerx (KERX 3.36, +0.62, +22.63%) will be able to submit data to support its market application on a rolling basis, which can help expedite the Food and Drug Administration's review process. Keryx is seeking to have the product approved for the treatment of colorectal cancer.
Keryx shares shot up 23% to $3.38 in afternoon trading.
In a statement, Keryx said it plans to begin Phase III testing in the second quarter, forecasting that the product could be out on the market in mid-2012.
Perifosine is licensed from Aeterna Zentaris /quotes/comstock/15*!aezs/quotes/nls/aezs (AEZS 0.96, +0.16, +19.42%) , shares of which rocketed 21% to reach 97 cents.
Meanwhile, shares of Forest Laboratories /quotes/comstock/13*!frx/quotes/nls/frx (FRX 30.97, -0.46, -1.46%) traded down 1% at $31.09.
An FDA advisory panel is expected to review the company's market application for new pulmonary drug Daxas at a meeting Wednesday.
The drug sector's two leading indexes were fairly sluggish in afternoon trading. The NYSE Pharmaceutical Index /quotes/comstock/10t!drg.x (DRG 308.24, -1.25, -0.41%) was a bit lower at 308.53, while the NYSE Biotechnology Index /quotes/comstock/10t!btk.x (BTK 1,245, +2.83, +0.23%) was up nominally at 1,244.12.
Val Brickates Kennedy is a reporter for MarketWatch in Boston.
Keryx Biopharma receives FDA Fast track designation for KRX-0401 (Perifosine) for the treatment of refractory advanced colorectal cancer (KERX) 2.74 : Co announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
52wk Range: 0.14 - 3.56
Volume: 24,464,612
Avg Vol (3m): 1,242,560
Market Cap: 192.72M
P/E (ttm): 16.25
EPS (ttm): 0.21
Div & Yield: N/A (N/A)
Technicals
Most Actives
Gap Up
Percentage Gainer
Last Price Quote is:
21.90%above 13-day MA
26.47%above 50-day MA
RS Rating: 89
Fundamentals
Earnings Expected on May 12
Key Data:
Market Cap (M): $153.39
P/E Ratio: 11.80
PEG Ratio: N/A
Next Earnings: 05/12/2010
Last Analyst Rating: Mkt Outperform
Target $6-7, stop $2.91
development-stage drugs including renal disease and cancer. Above the 50-day.
1,632% run since May 7, 2009 when the stock price was @ $0.1934 a share
also here is the 1 year chart ;) :D ;D
;D another fine move,
from the BreakOut of the Symmetrical Triangle (continuation) pattern.
Drug Manufacturing Industry on an Explosive Journey...
Press Release Source: Rothman Research On Wednesday April 21, 2010, 8:43 am EDT
JOHANNESBURG, SOUTH AFRICA--(Marketwire - 04/21/10) - http://www.rothmanresearch.com/ - Needless to say that the drug manufacturing industry is a multi-billion dollar industry that is set to experience ongoing growth mid- to long-term. With this anticipated industry growth and increased competition in the drug market, the number of mergers and acquisitions would be on the rise as major players will strive to become more aggressive in their attempt to boost their market presence by increasing their product-line through new acquisitions. This trend is not new within the industry, but it is certainly on an uptrend. Abbott Laboratories (NYSE:ABT - News), one of the major players within the pharma industry, has been one busy bee in the M & A front with its strings of broad-based acquisitions. Many experts believe that this sudden interest in M & A was triggered by the fact that Humira, one of the company's star medications, will lose U.S. patent protection in the next 7 years.
*Complimentary downloadable research on Abbott Laboratories is accessible upon registration at http://www.rothmanresearch.com/article/abt/23455/Apr-21-2010.html
The major drug manufacturer, in an effort to broaden its product-line, went on a rampage by acquiring numerous small- to-midsize companies, thus helping the company to steer away from its over-dependence on its performing products. Abbott will be releasing its first quarter results today pre-market and analysts believe that the company will deliver positive figures supported by sales of Humira and the company's cost cutting efforts. "There will be a lot of attention on Humira sales performance for this quarter, however, there are also growing concerns about Abbott's U.S. pharmaceutical business which has already recorded a sales decline of more than 8.5% in its last reported quarterly readings. Another key factor that the street and industry professionals will be focused on in the mid-term is the impact of the new healthcare law on companies like Abbott," commented Mathew collier of http://www.rothmanresearch.com/.
* http://www.rothmanresearch.com/ is a source for investors seeking free information on the major drug manufacturers industry; investors are encouraged to sign up for free at http://www.rothmanresearch.com/index.php?id=6&name=Register.
Another driving force for the industry's growth potential is the increasing R & D investments in markets where demand is extremely high like cancer. Companies like Keryx Biopharmaceuticals Inc. (NASDAQ:KERX - News) is already making great strides in this field of research. The company was recently given a Fast Track designation from the FDA for development of Perifosine in advanced colorectal cancer, which is the third most widespread form of cancer identified in the U.S. Competition in the colorectal cancer market space is huge, but demand remains high.
*Direct & free downloadable report on Keryx Biopharmaceuticals Inc. is available by signing up now at http://www.rothmanresearch.com/article/kerx/23456/Apr-21-2010.html
Keryx is expected to release its earnings reading on May 10th and there is already a lot a buzz that the company's share price could be heading for a double by next year.
Companies looking for additional media or advertising services can call Blue Chip IR at 1-917-267-8836.
About Rothman Research
Rothman Research brings independent company and sector research together, utilizing top financial advisors and investment tactics to provide you with a clear picture of investment opportunities.
Contact:
For More Information Contact:Mathew
[email protected]
The top five performing stocks of the past 52 weeks overall ...
Make no mistake ...
I'm not showing you these two tables to try to talk you out of investing in large-cap stocks. In fact, I selected these five large caps because I think they're all potentially great investments. The first three are official Motley Fool recommendations, and I personally own shares of the last two.
But as you can clearly see, the size of a company puts major limits on its growth potential. And the larger the company, the more analysts are following its every move –and the less likely the market is to misjudge its value.
In other words, if you want to score really big ...
You've got to dedicate a portion of your time to finding stocks that -- just like the small-caps listed above – are small, obscure, and ignored. Don't forget that because relatively few analysts are covering these stocks, there is a much greater chance that the market is undervaluing them.
There's one more point worth pondering here. Whereas a company like American Express would have to pack on another $55 billion in value for its shares to merely double, any of these five-small cap stocks' shares would soar at least 500% if they gained just half that amount.
keeps on trucking..
updated chart look
Below the 1 year chart...
KERX Keryx Biopharmaceuticals Announces Highly Statistically Sign...
NEW YORK, Nov. 30, 2010 /PRNewswire via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX, Trade ) today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex(TM) (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. In this study, conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA), Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant dose response. In addition, key secondary endpoints were also met with high statistical significance.
STUDY DESIGN
This Phase 3 study was a multicenter, randomized, open-label trial with a two-week washout period, following which patients were randomized 1:1:1 to receive a fixed dose of Zerenex of either 1 gram, 6 grams or 8 grams per day for a treatment period of 28 days. Zerenex was administered using a 1 gram oral caplet formulation, hence, the fixed-dose arms of 1 gram, 6 grams and 8 grams per day represent 1, 6 and 8 pills per day, respectively.
One hundred fifty-one dialysis patients were enrolled into the study. The Intent-to-Treat (ITT) group included 146 patients, representing all patients who took at least one dose of Zerenex and provided a Baseline (at the end of washout) and at least one post-Baseline efficacy assessment. Efficacy assessments were taken weekly starting at Baseline and subsequently at days 7, 14, 21 and 28.
EFFICACY DATA ANALYSES
The primary endpoint of the study was to determine whether there is a dose response in the change in serum phosphorus from Baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.
The study met the primary endpoint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).
Additional efficacy results are as follows:
Mean Serum Phosphorus (mg/dL) 1g/Day 6g/Day 8g/Day
ITT (n=146) (n=50) (n=51) (n=45)
---------------------------------------------------- ------ ---------- ----------
Baseline (End of Washout) 7.3 7.6 7.5
---------------------------------------------------- ------ ---------- ----------
Day 28 (End of Treatment) 7.4 5.7 5.3
---------------------------------------------------- ------ ---------- ----------
Change from Baseline at Day 28 0.1 -1.9 -2.2
P-Value !!!!0.0001 !!!!0.0001
---------------------------------------------------- ------ ---------- ----------
% Change from Baseline at Day 28 0.5% -25.0% -28.8%
---------------------------------------------------- ------ ---------- ----------
Change from Baseline at Day 28 vs. 1g/Day Dose Group -2.0 -2.3
P-Value !!!!0.0001 !!!!0.0001
---------------------------------------------------- ---------- ----------
In addition, a statistically significant dose response increase in serum bicarbonate was observed in the study, indicating the potential ability of Zerenex to manage metabolic acidosis, as seen in prior clinical studies with Zerenex. Metabolic acidosis is a condition that occurs in many dialysis patients when the kidneys do not remove sufficient acid from the body, leading to low blood pH. The consequences of metabolic acidosis can be severe, including coma and death. The inability to manage metabolic acidosis is believed to be a drawback for some of the currently marketed phosphate binders.
Importantly, and as anticipated, no clinically meaningful change in serum calcium was observed in the study. Additionally, a statistically significant dose response reduction in calcium-phosphorus product was also observed in the study. Elevated levels of serum calcium (hypercalcemia) and high levels of calcium-phosphorus product, both of which are believed to be drawbacks from the use of some of the currently marketed phosphate binders, increase the risk of soft tissue calcification and may contribute to the substantial morbidity and mortality seen in patients with end-stage renal disease.
Certain iron parameters, including ferritin and TSAT, were measured in the study. Modest upward trends in ferritin and TSAT levels were observed in the 6 grams/day and 8 grams/day dose groups, which further support the Company's belief that Zerenex has the potential to reduce the need for intravenous (IV) iron supplements and/or erythropoiesis-stimulating agents (ESAs) in dialysis patients. IV iron and ESA use is being evaluated in the ongoing Phase 3 long-term study. If reductions in use are confirmed, the Company believes this additional benefit would significantly expand Zerenex's market potential.
Zerenex appeared to be safe and well-tolerated in the study, with only nine patients (6%) in the ITT group dropping out of the study, which further supports Zerenex's favorable safety profile seen in prior clinical trials.
The full efficacy and safety data from the study is expected to be presented at a future medical conference.
Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, member of the Executive Committee of the Collaborative Study Group and Study Chair of the Zerenex Phase 3 registration program, commented, "This is a very important day for all of us involved in the Zerenex program. Based on the results of this Phase 3 study, it appears that the Zerenex efficacy and safety profile is emerging in a way that could make it the phosphate binder of choice for dialysis patients." Dr. Lewis continued, "We are very excited to have taken this step forward towards bringing Zerenex to the patients who are in need of additional alternatives to the existing phosphate binders."
Ron Bentsur, Chief Executive Officer of Keryx, stated, "The successful completion of this Phase 3 study is perhaps the most important milestone in Keryx's history. We are excited to be announcing these robust results which demonstrate Zerenex's potential benefits over the currently marketed phosphate binders, including advantages in pill burden, safety and compliance. We believe that the data presented today and the overall profile of Zerenex position the drug candidate to potentially become market leader in this $1.5 billion, rapidly growing market." Mr. Bentsur continued, "We sincerely thank the study investigators and coordinators, and we are particularly grateful to the Collaborative Study Group, whose expertise, guidance and dedication have been extraordinary."
CONFERENCE CALL INFORMATION
Keryx will host a conference call today, November 30, 2010, at 8:30 a.m. EST, to discuss the top-line results from this study. In order to participate in the conference call, please call 1-877-869-3847 (U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The rebroadcast of the conference call will be available for replay at http://www.keryx.com , for a period of 15 days after the call.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. The Phase 3 program in Japan is pending commencement.
About the Zerenex Phase 3 Program
In accordance with the Company's SPA agreement with the FDA, in addition to the short-term Phase 3 study reported on today, the Company is also conducting a long-term (58-week) Phase 3 safety and efficacy study for which enrollment is ongoing. The long-term study is a multicenter, randomized, open-label, safety and efficacy clinical trial with a planned enrollment of approximately 300 patients on hemodialysis or peritoneal dialysis. The long-term study will consist of a 2-week washout period followed by a 52-week safety assessment in which patients will be randomized 2:1 to receive either Zerenex or another phosphate binder. The 52-week safety assessment will be followed by a 4-week efficacy assessment in which only patients randomized to treatment with Zerenex during the safety assessment will be randomized to continue treatment with either Zerenex or placebo for a 4-week period. Keryx expects to complete the Zerenex Phase 3 long-term study and file a New Drug Application for Zerenex for the treatment of hyperphosphatemia by mid-2012.
About Hyperphosphatemia
According to data from the U.S. Renal Data System, in the United States, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 patients by 2020. The majority of ESRD patients, close to 400,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an effective and safe treatment in lowering and/or maintaining normal serum phosphorus levels in patients with ESRD and hyperphosphatemia.
The market for phosphate binders is approximately $750 million in the U.S. and $1.5 billion worldwide annually.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.
Final marketing approval depends on the efficacy and safety results, including the adverse event profile, and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf .
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex(TM) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for Zerenex; top-line results are based on a preliminary analysis of then available data (both safety and efficacy) and there is the risk that that such findings and conclusions could change following a more comprehensive review of the data; the risk that the data (both safety and efficacy) from the long-term Phase 3 trial will not coincide with the data analyses from the short-term Phase 3 and Phase 2 clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com . The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail:
[email protected]SOURCE Keryx Biopharmaceuticals, Inc.
Would like to see it top $5.75 this week.
News will be coming out by year end that could send this much much higher ($7?). ???
KERX can easy sky rocket like DNDN.
Day's Range: 5.41 - 5.91
52wk Range: 2.22 - 6.67
Volume: 6,288,812
Avg Vol (3m): 1,175,640
Technicals
Last Price Quote is:
4.84%above 13-day EMA
9.17%above 50-day EMA
RS Rating: 90
KERX Phase 2 Data Presented at the 52nd Annual Meeting of...
NEW YORK, Dec. 6, 2010 /PRNewswire via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX) today announced data presented for the first time at the 52nd Annual Meeting of the American Society of Hematology showing promising clinical activity, safety and tolerability of perifosine in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). KRX-0401 (perifosine) is the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. Key highlights from the two Phase 2 poster presentations are as follows:
Abstract # 2861: "Clinical Activity and Safety of the Combined Therapy with the AKT Inhibitor Perifosine and the Multikinase Inhibitor Sorafenib In Heavily Pretreated Patients with Relapsed/Refractory Lymphomas: Preliminary Results of a Phase II Trial"
Study Background: In this Phase 2 study, 26 patients were enrolled with advanced lymphoma (6 NHL, 4 CLL, 1 Waldenstroms and 15 Hodgkin's lymphoma). 73% of patients were previously refractory to their prior therapy, with 85% of patients having had 4 or more prior therapies. Perifosine (50 mg BID) was started as a single agent for 28 days; After 28 days, patients achieving partial response (PR) or better were continued on single agent perifosine. Patients achieving less than a PR were given the combination of perifosine (50 mg BID) plus sorafenib (Nexavar(R)) at 400 mg BID.
Results: All of the 4 CLL patients in the study achieved a partial response on single-agent perifosine within one month of treatment and remained on perifosine single agent. Response durations for each of the 4 patients were 4, 8, 9+ and 12 months. The remaining 22 patients were administered the combination with sorafenib, where 5 of the 15 (33%) Hodgkin's lymphoma patients achieved a partial response with a median response duration of 9 months. An additional 6 patients receiving the combination (40%) achieved stable disease. The combination was well tolerated with no unexpected safety events.
The investigators concluded that perifosine in combination with sorafenib has significant anti-lymphoma activity in relapsed/refractory HL, and that perifosine as a single agent induced prolonged responses in high-risk, heavily pretreated CLL patients.
Abstract # 1842: "Pre-Clinical and Interim Results of a Phase II Trial of Perifosine In Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)"
Study Background: In this Phase 2 study, 12 patients with advanced CLL began treatment with single agent perifosine at 50 mg BID. Patients on study were heavily pre-treated having had a median of 4 prior lines of therapy with 75% of patients classified as Rai stage IV.
Results: 1 patient achieved a partial response (5 months on treatment) and 5 additional patients achieved stable disease (median duration of 4.25 months), for an overall 50% clinical benefit rate (PR + SD). Perifosine was well tolerated with minimal dose modifications.
Abstract #3064: "Final Phase I Results of Perifosine In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (MM)"
Additionally, the final dataset from the Phase 1 study of perifosine + lenalidomide (Revlimid(R)) + dexamethasone was also presented during the ASH meeting. The final data showed a 73% objective response rate (minimal response or better) with a 50% PR or better, a median Progression-Free Survival of 10.8 months, and a median duration for Overall Survival of 30.6 months. The myeloma investigators concluded that perifosine in combination with lenalidomide + dexamethasone was well tolerated even at the highest doses used, and demonstrated encouraging clinical activity and survival.
Ron Bentsur, CEO of Keryx, commented, "The data presented at the ASH meeting further demonstrate perifosine's potential beyond the ongoing Phase 3 registration trials in metastatic colorectal cancer and multiple myeloma. It is encouraging to see perifosine's activity as a single agent and in combination with sorafenib in heavily pre-treated, advanced CLL and HL patients, respectively. Moreover, the perifosine-Revlimid(R) (+ dexamethasone) combination data in multiple myeloma also presented at ASH indicate that the combination is well tolerated demonstrating promising clinical activity."
Perifosine is currently in Phase 3 clinical trials for refractory advanced colorectal cancer and multiple myeloma. Both of these Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and with Fast Track designations obtained for both indications. Perifosine is also in Phase 1 and 2 clinical development for several other tumor types.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401 (perifosine); the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com . The information found on our website and the ASH website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail:
[email protected]SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Announces Commencement of Phase 3 Program of Ferric Citrate (Zerenex) in Japan by Partner, Japan Tobacco and Torii Pharmaceutical
Clinical Milestone Triggers Payment to Keryx
Press Release Source: Keryx Biopharmaceuticals, Inc. On Monday April 18, 2011, 8:30 am EDT
NEW YORK, April 18, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX - News), announced today that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), JT's pharmaceutical business subsidiary, has commenced the Phase 3 clinical program of ferric citrate in Japan for the treatment of patients with hyperphosphatemia. Under the license agreement with JT/Torii, within 30 days, Keryx will receive a non-refundable milestone payment of $5 million from JT/Torii for the achievement of this milestone. Zerenex™ (ferric citrate), a ferric iron-based phosphate binder, is also in Phase 3 clinical development in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis.
Ron Bentsur, Chief Executive Officer of Keryx, stated, "We congratulate our partner, JT/Torii, on the initiation of the Phase 3 program in Japan and are excited by their progress. We believe that this serves to further validate the commercial potential for Zerenex worldwide."
Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc.
Sublicense Agreement with Japan Tobacco & Torii Pharmaceutical
In September 2007, Keryx sublicensed to JT and Torii the exclusive rights for the development and commercialization of its hyperphosphatemia drug, Zerenex (ferric citrate), in Japan. The licensing arrangement calls for JT and Torii to pay to Keryx up to $100 million in up-front license fees and payments upon the achievement of specified milestones, of which $28 million has been received by Keryx to date. In addition, upon commercialization, JT and Torii will make royalty payments to Keryx on net sales of the drug in Japan. JT and Torii are responsible for all development and commercialization costs in Japan.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with approved therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex™ (ferric citrate) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability, and our Japanese partner's ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail:
[email protected]
InPlay...
8:32AM Keryx Biopharma announces commencement of Phase 3 program of Ferric Citrate in Japan by partner; Keryx will receive a non-refundable milestone payment of $5 mln from JT/Torii for the achievement of this milestone (KERX) 5.13 : Co announces that its Japanese partner, Japan Tobacco and Torii Pharmaceutical, JT's pharmaceutical business subsidiary, has commenced the Phase 3 clinical program of ferric citrate in Japan for the treatment of patients with hyperphosphatemia. Under the license agreement with JT/Torii, within 30 days, Keryx will receive a non-refundable milestone payment of $5 million from JT/Torii for the achievement of this milestone. Zerenex, a ferric iron-based phosphate binder, is also in Phase 3 clinical development in the United States for the treatment of hyperphosphatemia in patients with end-stage renal disease on dialysis.
Day's Range: 4.95 - 5.17
52wk Range: 3.03 - 6.67
Volume: 1,122,386
Avg Vol (3m): 1,184,010
Market Cap: 305.28M
P/E (ttm): N/A
EPS (ttm): -0.34
Div & Yield: N/A (N/A
Technicals
Close Above the 13-day EMA
Last Price Quote is:
-0.93%below 13-day EMA
7.71%above 50-day EMA
RS Rating: 84
8 Promising Biotech Buyout Targets if Their Products Can Deliver...
Thefollowing are a few biotechs with promising products in their pipelines that have made the big boys sit up and take notice. Without further ado, the 8 promising biotechs priced for a buyout if their products can deliver:
Keryx Biopharmaceuticals Inc. (KERX): Trading at $5.38, Keryx develops pharmaceuticals for the treatment of life-threatening diseases such as diabetes and cancer. Keryx has three products in clinical trials for various cancers, but one that stands out - Perifosine. Perifosine is in Class 3 clinical trials, and is a potential first-class, oral anti-cancer agent for colorectal cancer and multiple myeloma. The drugs' two Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and have been given the "Fast Track" designation. The drug is in Phase 1 and 2 trials for other types of tumors as well. If Perifosine does gain regulatory approval, the drug could be a potential blockbuster for Keryx with its ability to prevent multiple forms of cancer. With a Market Cap of $289 million, Perifosine could make Keryx an ideal takeover candidate. Shares currently trade at $4.96
Technicals
Close Below the 13-day EMA
Last Price Quote is:
-1.32%below 13-day EMA
7.27%above 50-day EMA
RS Rating: 83
A strong uptrend is in place...
and that the market remains positive longer term.
A triangle indicates the presence of a very strong trend that is
being driven by strong forces and insiders.