|NPS Pharma soars after drug meets trial goals. Nymox gains on updated Phase III results. Alexion acquires Taligen Therapeutics. After the bell: Array and Sinovac edge higher|
|By Mary Davila|
|Monday, 31 January 2011 19:40|
After the bell, shares of Array BioPharma Inc. (NASDAQ:ARRY) edged higher after the company reported financial results for the second quarter of fiscal 2011. The company reported a Q4 loss of 23 cents a shares which was 5 cents better than the consensus 28 cents per share loss. Revenues rose jumped 71.9% year over year to $16.5 million which was higher than the $16.4 consensus. In extended trading shares were up 20 cents or 7% to $3.10.
Shares of Sinovac Biotech Ltd. (Nasdaq:SVA) gained in extended trading after the provider of biopharmaceutical products in China, announced today the submission of the applications to commence human clinical trials for its 23-valent and 24-valent pneumococcal polysaccharides vaccines to the Chinese State Food Drug Administration (SFDA).
Dr. Weidong Yin, Chairman & CEO, commented, "PPV is the first bacterial vaccine for which the Company has submitted the clinical trial application to the SFDA, representing our expansion of our R&D capabilities to include both bacterial and virus vaccines. The establishment of our bacterial vaccine development platform will accelerate the R&D for the pneumococcal conjugate vaccine and other types of bacterial vaccines in our pipeline, such as the HIB and meningitis vaccines. We consistently advance our R&D strategy to provide a greater number of high quality vaccine products aimed at preventing diseases in children and adults around the world."
On heavy volume shares of Sinovac gained 19 cents or 4% to $4.83 after the bell.
After the bell, Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) announced today that the FDA has granted fast track designation for carfilzomib, a next generation proteasome inhibitor for the potential treatment of patients with relapsed and refractory multiple myeloma.
Shares of NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), soared today after the specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced that its Phase 3 pivotal study of GATTEX met the primary efficacy endpoint of reducing parenteral nutrition (PN) dependence in patients with adult short bowel syndrome. The 24-week randomized, double-blind study, known as STEPS, was designed to compare the efficacy, safety and tolerability of GATTEX to placebo. The company said the study showed patients receiving Gattex saw a 4.4-liter reduction in weekly intravenous volume to supplement nutritional needs compared to a 2.3-liter reduction in patients who received a placebo
Short bowel syndrome (SBS) can develop after sections of the bowel are removed due to Crohn's disease or other conditions. Because patients can no longer absorb nutrients and water they can suffer from severe diarrhea, malnutrition and dehydration. The company says patients who receive nutrients and fluids intravenously can develop blood clots, and kidney and liver damage with studies showing that Gattex helps restore normal intestinal function.
NPS plans to submit Gattex for FDA approval in the second half of 2011.
The stock surged $2.39 or 31.5% to $10.01 and was up another 27 cents in extended trading. More than 9.5 million shares traded hands.
Shares of Nymox Pharmaceutical Corporation (Nasdaq:NYMX) moved higher today after the company provided an update regarding Phase III pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The company reported that the Safety Monitoring Committee meeting of January 28, 2011 was favorable and indicated no significant safety concerns for the two pivotal U.S. trials to date. Patient recruitment and trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are proceeding well at over 70 well-known urology investigative sites throughout the U.S.
Shares gained 47 cents or 6.9% to $7.28.
Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced today that it has acquired Taligen Therapeutics, Inc., a privately held development-stage biotechnology company based in Cambridge, Mass. The acquisition broadens Alexion’s portfolio of product candidates and expands Alexion’s capabilities in translational medicine by bringing additional accomplished researchers to the Company. Alexion gains promising pre-clinical compounds, including potential treatments for patients with ophthalmic diseases such as age-related macular degeneration (AMD), as well as other novel antibody and protein regulators of the complement inflammatory pathways.
The acquisition was made with upfront cash payment of $111 million for 100 percent of Taligen’s equity interests. Additional contingent payments could be earned upon reaching various clinical efficacy and product approval milestones in both the US and European Union for up to six products.
BioMimetic Therapeutics Inc. (NASDAQ:BMTI), a biotechnology company specializing in the development and commercialization of innovative drug-device combination products to promote the healing of musculoskeletal injuries and diseases, today announced that the FDA has tentatively scheduled an Orthopedic and Rehabilitation Devices Panel meeting on May 12, 2011 to review the Company’s Premarket Approval application for Augment Bone Graft for the treatment of foot and ankle fusions in the U.S. If the panel determines the product’s benefits outweigh any potential risks, the Company expects approval of Augment by the FDA within three to six months after the panel date.
Genzyme Corp. (NASDAQ:GENZ) announced today that Genzyme’s board has authorized the company to enter into a confidentiality agreement with Sanofi-Aventis in order to allow Sanofi to conduct due diligence. Discussions between Genzyme’s advisors and Sanofi’s advisors and between Genzyme and Sanofi representatives are continuing and have focused to a significant degree on the potential use of a contingent value right for alemtuzumab as a part of a potential resolution of the differences in valuation between the parties, and the parties have also discussed other potential terms for a negotiated transaction.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) saw some wild trading Monday. Mid-afternoon today, the FDA posted the company's XYREM product on the agency's Adverse Event Reporting System list. The stock sold off sharply following the news, hitting a low of $20.74, before bouncing back and closing the day at $22.36, up 4 cents.
Manhattan Pharmaceuticals, Inc. (OTCBB:MHAN) announced today that the company's Board of Directors has decided to continue development of AST-915, an orally delivered treatment for essential tremor. This decision was made following the announcement of favorable clinical results from a Phase 1/2 clinical study of AST-915 conducted by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) under a CRADA agreement between the NIH and Ariston Pharmaceuticals, Inc., a wholly owned subsidiary of Manhattan Pharmaceuticals, Inc. Data from this study, previously announced on December 16, 2010, demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power. The company intends to continue to work with the NIH and to proceed toward Phase 2 with the AST-915 development program.
Under the terms of the merger agreement between Manhattan Pharmaceuticals, Inc. and Ariston Pharmaceuticals, Inc., the achievement of this milestone requires the company to issue 8,828,029 shares of its common stock to debt holders and former shareholders of Ariston.
Revolutions Medical Corporation (OTCBB:RMCP) announced today a major breakthrough in automatic retractable prefilled safety syringe technology. Building on the Company's proprietary vacuum based technology, important improvements in performance have been made that will set a new gold standard for safety in automatic prefilled syringes. The enhanced technology will provide for a level of passive protection from needle stick injury that is unmatched in the industry. Because of the small number of parts, longer shelf life, and elegance of the vacuum design, the price point will be far below that of any competitive prefilled safety syringe technology currently on the market.
Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT) today announced that the U.S. Food and Drug Administration FDA has classified the recent Intermezzo NDA resubmission as a complete Class 2 response and assigned a PDUFA action date of July 14, 2011 for the completion of the NDA review.
Amarin Corporation plc (Nasdaq:AMRN) , a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today issued a special letter to its shareholders.
Biodel Inc. (Nasdaq:BIOD) will issue its first quarter fiscal year 2011 financial results on February 3, 2011.