|Exelixis soars on cancer study data. SIGA bounces back. MELA gets FDA panel nod. After the bell: Somaxon tanks on offering|
|By BioMedReports.com Staff|
|Thursday, 18 November 2010 19:37|
Shares of Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX) fell in extended trading Thursday after the company announced that it intends to offer shares of its common stock in an underwritten public offering. Details were not disclosed. After the bell shares of Somaxon dropped 36 cents or 10.68% to $3.01.
Also after the bell, Amgen Inc. (Nasdaq:AMGN) announced that the U.S. Food and Drug Administration has approved XGEVA, the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a 6 month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.
Late Thursday, Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer (NYSE:PFE) reported that the companies have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent Acute Coronary Syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to apixaban. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.
News from earlier in the day:
Exelixis, Inc. (NASDAQ:EXEL) today reported interim data from patients treated with XL184 with Ovarian Cancer and Castration-Resistant Prostate Cancer. The company said the drug showed efficacy in shrinking tumors in ovarian cancer patients. Separately the company said the drug cleared up bone lesions from prostate cancer.
"The high response rate in patients with ovarian cancer is reflective of the broad anti-tumor activity of XL184 observed in multiple tumor types to date," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "The data from the RDT underscore the novel and differentiated clinical activity of XL184 in diverse tumor indications with predominance of either soft tissue or bone involvement."
Exelixis is testing XL 184 against nine other tumor types, including cancers of the skin, breast, prostate, brain, liver, and lungs.
Volume of more than 15 million shares propelled the stock to $6.23, up $1.51 or 32%.
Shares of SIGA Technologies, Inc. (Nasdaq:SIGA), were on the move Thursday after the company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, reported today that the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority ("BARDA") has announced a market survey to determine whether there is sufficient capacity among qualified small businesses to supply smallpox antiviral using the small business set-aside mechanism. If the current BARDA process confirms that SIGA is the only supplier that can meet the requirements for this biodefense countermeasure, and the only supplier capable of delivering the requested 1,700,000 courses of therapy in a timely manner, then BARDA may abandon the small business set-aside and adopt a different contracting mechanism.
"The U.S. Government's announcement reaffirms its commitment to acquire a smallpox antiviral for the protection of the U.S. population against the 'material threat' of a possible bioterrorism smallpox attack," stated Dr. Eric A. Rose, SIGA's Chairman and Chief Executive Officer.
SIGA surged on the news, jumping $1.41 or 12.51% to $12.68.
MELA Sciences, Inc. (NASDAQ:MELA) today announced that the General and Plastic Surgery Devices Panel appointed by the U.S. Food and Drug Administration voted by majority that, for its proposed indications, MelaFind® is safe and effective and that its benefits outweigh the risks.
"We are extremely pleased with the results of today's panel vote and look forward to working with the FDA during its ongoing review of the MelaFind® PMA application," said Joseph V. Gulfo, MD, President and CEO of MELA Sciences. "Melanoma is virtually 100% curable if detected at its earliest stage. The unfortunate reality is that one person in the U.S. dies from the disease every hour and it's the number one cancer killer in women ages 30-35. We designed MelaFind® to provide clinicians with objective information that can aid their decision on whether or not to biopsy a pigmented skin lesion that has characteristics of melanoma at its earliest stage."
Shares of MELA Sciences remained halted throughout Thursday trading.
3SBio Inc. (Nasdaq:SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products today announced that it has recently converted the remaining US$2.58 million of a US$4.5 million debenture convertible into Isotechnika Pharma Inc. common shares issued on August 23, 2010.