ONXX

[la-onda]

ONXX update (now looking interesting again imo):

1)
Onyx Pharmaceuticals Inc prices public offering of common shares
Friday , June 22, 2007 06:39ET

Jun 22, 2007 (M2 EQUITYBITES via COMTEX) -- Onyx Pharmaceuticals Inc (Nasdaq: ONXX), a biopharmaceutical company, reported on 21 June that it has priced its public offering of 6,600,000 common shares at USD28.00 per share. The company expects to complete the sale of these shares on or about 26 June 2007. Additionally, the company has granted the underwriters a 30-day option to purchase 990,000 additional common shares to cover over-allotments, if any.

2)
ONXX: Short Interest UP 13.6% to 7.8M in Jun 2007
Wednesday, June 27, 2007 06:00ET

According to new short interest data from NASDAQ, short interest for ONYX Pharmaceuticals Inc (NasdaqNM: ONXX) INCREASED 13.6% to 7,820,497 shares for the month ended mid-June, 2007.

SYMBOL        MAY            JUNE          CHANGE       %CHANGE        DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
ONXX     6,886,548     7,820,497    +933,949       +13.56%           3

Based on ONXX's 20-day average daily share volume of 3,449,955, it would require approximately 3 day(s) of buying to cover this short interest.

3)
Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer
Wednesday, June 27, 2007 07:00ET

WAYNE, N.J. and EMERYVILLE, Calif., June 27 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Supplemental New Drug Application (sNDA) for Nexavar(R) (sorafenib) tablets has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer. The companies also confirmed that they are planning a company- sponsored Phase 3 study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.

The sNDA submission is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.

"These results are particularly meaningful considering that death rates from liver cancer continue to increase," said Susan Kelley, M.D., vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "After more than 100 clinical studies of many agents over three decades, Nexavar is the first drug therapy to demonstrate a significant survival benefit for patients with HCC, and, if approved, may fulfill a serious unmet need with a manageable toxicity profile."

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary liver cancers in adults.(1,2) It is the fifth most common cancer in the world(3) and the third leading cause of cancer-related deaths globally.(4) Over 600,000 cases of HCC are diagnosed globally each year(4) (about 19,000 in the United States(5) and 32,000 in the European Union(6)) and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of HCC.(7)

"This filing exemplifies our commitment to providing valuable therapeutic options for significant unmet needs in cancer treatment," said Hank Fuchs, M.D., executive vice president and chief medical officer of Onyx. "We believe that Nexavar will become the reference standard of care in HCC, and will help advance our development program, which includes clinical trials studying Nexavar alone and in combination with other therapies across many different cancer types, including melanoma, non-small cell lung and breast cancer."

[fill_the_gap]

Hi,

Took some time off and am happy to be back.  Miss many of you on the board!

Been following ONXX since my initial post.

Buying August calls and the actual stock into Tuesdays cc.

Betting heavy on ONXX to rise several dollars.
http://stockcharts.com/h-sc/ui?s=onxx

Only drug for liver cancer and Bayer will make it interesting.

[la-onda]

Welcome back fill_the_gap   
Nice to have you back on board. What are your other holdings?
cheers
Oliver

ONXX update (not holding):
1)
Onyx Pharmaceuticals Schedules August 7 Earnings Call
Wednesday, August 01, 2007 07:39ET
(financialwire.net via COMTEX) -- August 1, 2007 (FinancialWire) Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) will webcast a teleconference with management to discuss second quarter 2007 financial results and provide a general business overview on August 7 at 5 p.m. ET. Financial results for the second quarter ended June 30 will be released earlier that day.
A live webcast of the presentation will be available at streamlogics.net. A replay of the presentation will be available on the Onyx website or by phone around one hour after the teleconference concludes. The replay will be available through September 6.
Emeryville, California-based Onyx Pharmaceuticals is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer.

2)
ONXX: Short Interest UP 12.1% to 8.8M in Jul 2007
Tuesday , July 24, 2007 16:20ET

According to new short interest data from NASDAQ, short interest for ONYX Pharmaceuticals Inc (NasdaqNM: ONXX) INCREASED 12.1% to 8,766,221 shares for the month ended mid-July, 2007.

SYMBOL         JUNE            JULY          CHANGE       %CHANGE         DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
ONXX           7,820,497       8,766,221        +945,724       +12.09%           8

Based on ONXX's 20-day average daily share volume of 1,127,870, it would require approximately 8 day(s) of buying to cover this short interest.

3)
Nice chart action:

[fill_the_gap]

Thank you!  It is nice to be back.

MO and KFT look good to me right here.

Banking on a solid ONXX call tomorrow.  Usually do not hold into a call but this time may work, imo.

Good luck.

[fill_the_gap]

 

Revenue from Nexavar, one of the company's newest products, jumped by 160 percent to 60 million euros. Recent studies showed that the product is the first drug to prolong survival in kidney cancer patients. Rivaroxaban, an anti-clotting drug, was shown to be safer and more effective than a competing treatment, pushing up the share price.

http://www.bloomberg.com/apps/news?pid=20601087&sid=aE.VVf_dz2_I&refer=home

[fill_the_gap]

Call is after hours today.

Sold most as up 120% on options and do not want to get greedy.

[la-onda]

BAY: Releases Results from Study; Nexavar Tablets Found Effective
Monday , August 27, 2007 08:38ET

Bayer HealthCare Pharmaceuticals (BAY) and Onyx Pharmaceuticals, Inc. (ONXX) announced that a planned review by an independent data monitoring committee (DMC) found that Nexavar(R) (sorafenib) tablets significantly improved overall survival, progression free survival, and time to progression in an Asia-Pacific regional Phase 3 trial of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.

Based on the DMC's recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar. Data from this study will be submitted for presentation at an upcoming scientific meeting.

&

Pill may mean windfall for drugmaker: News of Onyx Pharmaceuticals' successful trial of liver cancer treatment sends company's stocks soaring
Tuesday , August 28, 2007 08:43ET

David Morrill

Aug 28, 2007 (Contra Costa Times - McClatchy-Tribune Information Services via COMTEX) -- The lone drug of Onyx Pharmaceuticals Inc. has the potential to become a major cash cow for the Emeryville-based company if it can penetrate a liver cancer market estimated by analysts to be worth about $3 billion.

On Monday, the company reported that a trial in Asia using Nexavar showed such favorable results in patients with late-stage liver cancer that Onyx chose to end the study. Shares of the company surged more than 10 percent on the news, up $3.42, to close at $37.04.

"What this news does is it provides investors some real visibility on a real large Asian opportunity that in some sense many may not have thought a whole lot about before," said Jim Birchenough, an analyst with Lehman Brothers in San Francisco.

News of this study mirrors a second study in February that was also halted because of favorable results. Specific results of the data will be presented at an upcoming scientific meeting, the company said.

Onyx and its partner, Bayer Pharmaceuticals Corp., will now seek approval from U.S. and European regulators to sell Nexavar for treating liver cancer. In December 2005, the drug was approved for treating kidney cancer.

Nexavar is seen as a drug with great potential. It is often compared to the blockbuster drug Avastin, manufactured by biotechnology giant Genentech. Both drugs target a tumor cell's ability to grow by cutting off its blood supply.

One potential advantage Nexavar has over Avastin is that it's taken orally, versus intravenously at a medical clinic.

"One way to look at it is that it targets the same properties as Avastin, as well as other things beyond," Birchenough said. "So ultimately. it could be as big, if not bigger than Avastin."

The liver cancer market is valued at about $3 billion annually, based on about 15,000 patients in the United States, 45,000 to 60,000 in Europe, 30,000 in Japan and 500,000 in Asian countries outside of Japan.

It's higher in the Asia-Pacific region because of a greater prevalence of hepatitis C infection, which causes the number of liver cancer incidence to rise.

Last year, the Food and Drug Administration gave Nexavar "fast track" status, which allows the approval process to be sped up.

This designation is given to drugs that treat serious or life-threatening diseases where there is an unmet medical need. Liver cancer is the fifth most common cancer in the world and is the most prevalent in developing countries.

chart:

[setravis]

Event.......
Record Price Break Out !


52wk Range: 10.38 - 31.28
Volume: 6,048,221
Avg Vol (3m): 3,346,020

Technicals
Record Price High
Most Actives
Record Price Break Out
Percentage Gainer

Last Price Quote is:
7.41%above 13-day MA
15.98%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $1,434.87 
P/E Ratio: NA 
PEG Ratio: -0.88 
Next Earnings: 08/07/2007

Onyx Pharmaceutical shares leaped and partner Bayer AG... BAY
said early Monday that they ended a Phase III clinical trial for their oncology drug Nexavar early because of better-than-expected results. The companies are testing Nexavar, which is already approved to treat kidney cancer, for the treatment of advanced hepatocellular carcinoma, the most common form of liver cancer.
As a result of the early termination, all the patients in the trial will now have access to the drug. The FDA is expected to decide on whether to approve Nexavar for liver cancer within six months.
Bayer investors appeared to be less enthused, pushing down shares about 2%

Cup with Handle (continuation).......

52wk Range: 10.38 - 42.63
Volume: 3,047,946
Avg Vol (3m): 2,189,230

Technicals
Record Price High

Last Price Quote is:
16.24%above 13-day MA
31.27%above 50-day MA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $2,167.38 
P/E Ratio: NA 
PEG Ratio: -1.708 
Next Earnings: 11/06/2007
Last Analyst Rating: Outperform

[la-onda]

setravis, whats your opinion about ONXX?
cheers
O.

ONXX update:

Big on Onyx's Nexavar

Onyx Pharmaceuticals (Nasdaq: ONXX) delivered strong financial performance of Nexavar in 3Q07 in spite of heavy competition in the kidney cancer market from Pfizer (NYSE: PFE) and Wyeth (NYSE: WYE). We are optimistic about the potential of oncology candidate Nexavar (sorafenib). We believe Nexavar sales will continue to grow over the next several years since the label has expanded to liver cancer. Label expansion into other cancer indications are under way. Nexavar has the potential to become a blockbuster for Onyx. Nexavar sales continued to grow in 3Q07 in spite of heavy competition from Pfizer's Sutent and Wyeth's new drug Torisel for kidney cancer indications. Total Nexavar sales came in at $104.6 million, up 130% from $45.4 million in 3Q06. US sales increased to $41 million in 3Q07 from $28.4 million in 3Q06, up 44.4%. International sales reached $63.6 million, up 274% from $17 million in 3Q06. EU and the US approved Nexavar for 1st line treatment of liver cancer in 4Q07. Other international filing is underway. We believe Nexavar sales will be further boosted in 2008 and beyond due to this new indication. We model sales of Nexavar will reach $1 billion in 2010. The stock's current price is attractive; therefore, we upgrade Onyx shares to Buy from Hold with a price target of $64 per share.

January 2008 presentation:

http://www.onyx-pharm.com/pdf/Corporate_Presentation.pdf


latest news:
FRANKFURT, Jan. 22, 2008 (Thomson Financial delivered by Newstex) -- Bayer AG (NYSE:BAY) said the risks of high-blood pressure associated with its Nexavar cancer drug that were highlighted in an article in UK science journal The Lancet Oncology are known and covered by the labelling. 'Currently approved product labelling for Nexavar states that hypertension may occur, usually at the beginning of the course of the therapy, and is managed with anti-hypertensive agents,' Bayer spokesman Oliver Renner said. An analysis of nine studies in which Nexavar was tested on a total of 4,599 patients suffering from kidney cancer and other solid tumours, published by The Lancet, concluded that the drug was 'associated with a significantly increased risk of all-grade hypertension' and that 'appropriate monitoring and treatment is strongly recommended.' 'This is a known risk and it is covered by the currently approved product labelling,' Bayer's Renner commented on the on the article.
http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-22419161.htm

&

Bayer/Onyx Pharmaceuticals: Nexavar approved for kidney cancer in Japan

Monday , January 28, 2008 11:39ET

Jan 28, 2008 (Datamonitor via COMTEX) -- Nexavar has been approved in Japan for use in metastatic renal cell carcinoma patients. This makes Nexavar the first oral targeted therapy to be approved in this major pharmaceutical market for this indication. This approval will significantly advance the outcomes of patients affected with renal cell carcinoma as well as further enhance Nexavar's success. Nexavar (sorafenib) is a multi-kinase inhibitor that targets angiogenesis and cell proliferation mediators such as Raf kinase, the platelet-derived growth factor receptor (PDGFR) family and the vascular endothelial growth factor receptors (VEGFR) 2 and 3. It was the first targeted therapy to be approved for metastatic renal cell carcinoma (RCC) in the US in December 2005 with subsequent EU approval in July 2006. Approval was based on results from a randomized Phase III trial of more than 900 metastatic RCC patients which showed that Nexavar slowed tumor progression by 24 weeks compared to 12 weeks in the placebo group. However, it remains to be seen if this tumor growth suppression translates into a survival benefit for these patients. Kidney cancer affects over 200,000 people annually worldwide with about a third of patients presenting with metastatic disease. Renal cell carcinoma is the most common form of kidney cancer and accounts for around 8,000 new cases per year in Japan alone. RCC has been associated with high levels of unmet need and traditional cytokine therapy produces very low response rates. This presented a strong demand for better alternatives in advanced patients. The approval of targeted therapies such as Nexavar, Pfizer's Sutent (sutinib) and Wyeth's Torisel (temsirolimus) for RCC in recent years has positively widened the treatment options available for these patients. Nexavar competes with Sutent and Torisel in the US (Sutent approved January 2006; Torisel approved May 2007) and EU (Sutent approved July 2006) metastatic RCC markets. However, with its most recent approval in Japan, Nexavar will be able to exclusively penetrate this market as it is the first oral targeted therapy to be approved here. Bayer and Onyx Pharmaceuticals co-develop Nexavar worldwide, except in Japan where it is developed and marketed by Bayer. Nexavar is also approved in both the US and EU for advanced hepatocellular carcinoma. In September 2007, a new drug application for Nexavar was filed for use in patients with hepatocellular carcinoma in Japan for which priority review status has been recently granted. Approval in this additional indication will no doubt further boost Nexavar's success in this major pharmaceutical market.

Chart: