Exelixis soars on cancer study data. SIGA bounces back. MELA gets FDA panel nod. After the bell: Somaxon tanks on offering Print E-mail
By BioMedReports.com Staff   
Thursday, 18 November 2010 19:37

Below is a look at some of the headlines for companies that made news in the healthcare sector on November 18, 2010.

 

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.

Also Thursday:

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.

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has applied to the U.S. Food and Drug Administration for orphan drug designation for ALS-886, a novel therapy to reduce and prevent tissue damage, for the treatment of Acute Respiratory Distress Syndrome (ARDS).

Aeterna Zentaris Inc. (Nasdaq:AEZS; TSX: AEZ) today presented Phase 2 positive efficacy and safety data for its compound, AEZS-108, in advanced endometrial cancer.

Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the appointment of Kristine Peterson to its board of directors.

Fresh Start Private (OTCBB: CEYY), a leader in the alcohol treatment and rehabilitation industry, today announced that it has signed an exclusive agreement with Trinity Rx Solutions (TRS) of New York, the manufacturer of the Naltrexone Implant Product used in the Fresh Start Private Management Inc (FSPM) treatment program.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, announced today that Interim CFO Peter Osborne is scheduled to present at the 22nd Annual Piper Jaffray Health Care Conference.

HeartWare International, Inc. (Nasdaq:HTWR) (ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to make an investor presentation at the 22nd Annual Piper Jaffray Health Care Conference on Tuesday, November 30, at 3:00 pm EST.

iMedicor (OTCBB: VMCI), originators of the National Healthcare Communication Network (NHCN), a HIPAA compliant transport and communications network designed to move electronic medical records in a secure environment, today announced the execution of its first IPA contract with the Stone Center, a group of 120 Urologists based in New Jersey.

Medizone International, Inc. (OTCBB: MZEI) (OTCQB: MZEI) announced today that it has entered into a common stock purchase agreement establishing a $10,000,000 equity line with Mammoth Corporation of Lake Zurich, IL.

NeoStem, Inc. (NYSE Amex:NBS) an international biopharmaceutical company with operations in the U.S. and China, today announced that Dr. Robin Smith, the Company's Chairman and CEO, will present at the 2010 Maxim Group Growth Conference this morning and at the Proactive Investors One2One Investor Forum this evening.

NicOx S.A. (NYSE Euronext Paris: COX) today announced that Dr. Jacques Djian, Vice President of Exploratory Development and Translational Medicine at NicOx, recently presented results from the phase 1b first-in-man study for NCX 6560 in an oral session of the American Heart Association (AHA) 2010 Scientific Sessions being held in Chicago, Illinois.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) announced today that the Children's Oncology Group (COG) intends to conduct a Phase I trial of REOLYSIN® in combination with cyclophosphamide in pediatric patients with relapsed or refractory solid tumors.

Oncothyreon Inc. (Nasdaq:ONTY) today reported updated results from a Phase 1 clinical trial of PX-866, an irreversible small molecule phosphatidylinositol-3-kinase (PI-3K) inhibitor, in patients with advanced solid tumors.

Prime Healthcare and Masimo (Nasdaq:MASI) today jointly announce the system-wide conversion of Prime Healthcare's hospitals to Masimo rainbow® SET technology.

ProPhase Labs, Inc. (NASDAQ: PRPH), makers of the Cold-EEZE® brand of cold remedies, announced today it will be the title sponsor of the Cold-EEZE Improv-Ice show airing on NBC stations Sunday, November 21st from 4:00-6:00pm EST.

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today reported that the Phase I/II clinical trial for its orally available JAK1/JAK2 inhibitor, CYT387, in patients with myelofibrosis has been expanded to five sites.

 

 




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter