KERX - Sector: Healthcare --- Industry: Drug Manufacturers - Major

[setravis]

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

[setravis]

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

[setravis]

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

[setravis]

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

[Protocol Guy]

New research note from Brean Murray Carret & Co, with a $3 price target:

[setravis]

rolling on...

[setravis]

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]

[setravis]

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)

[setravis]

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.

[setravis]

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.

[setravis]

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.

[setravis]

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.

[setravis]

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

[setravis]

also here is the 1 year chart 

[setravis]

  another fine move,
from the BreakOut of the Symmetrical Triangle (continuation) pattern.