|Chelsea Therapeutics Volatile Before Panel Vote; Forest Labs Receives European Marketing Approval|
|By Staff and Wire Reports|
|Friday, 24 February 2012 20:39|
An FDA advisory panel voted 7-4 to recommend approval for Chelsea Therapeutics' (NASDAQ: CHTP) drug called Northera which is a treatment for a condition which can cause dizziness in people with central nervous system disorders. Shares were halted in the wake of the decision.
When Chelsea re-opened in the after hours trading session, the stock hit a high of $4.80 and ended the late trading session at $4.21. On Friday, the stock has pulled back from those after hours highs, and opened at $4.03. At last check, CHTP had fallen another $0.11 cents to $3.92 for a gain of 62.65% on the day.
The $4 level appears to be near-term resistance in the name, and if CHTP can break this level to the upside during Friday's session it could run higher. If approved, Northera would be CHTP's first commercial drug.
Forest Laboratories, Inc. (NYSE:FRX) announced it has been granted European Medicines Agency approval to market Colobreathe dry powder colistimethate sodium for inhalation for treating cystic fibrosis patients aged 6 years and older with chronic lung infection caused by P. aeruginosa. The pivotal clinical study of Colobreathe demonstrated the benefits and its ability to prevent deterioration of respiratory function in Cystic Fibrosis patients.
The pivotal study which was submitted to EMA for authorization was an open-label active comparator study comparing the efficacy of Colobreathe to TOBI (tobramycin nebuliser solution for inhalation). This study also demonstrated better patient acceptability of Colobreathe. Importantly, data from the study of Colobreathe showed that overall the product was well tolerated and there was no emergence of antibacterial resistance.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that the new line of Waterlase MDX™ all-tissue lasers was launched this week at the annual Chicago Dental Society Midwinter Meeting being held through February 25 (Booth #1237).
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a developer of innovative stem cell technologies for neurodegenerative disorders, announced that NurOwn™, its autologous stem cell therapy for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's Disease, was profiled yesterday on CNBC.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced the pricing of an underwritten public offering of 10,500,000 shares of its common stock, offered at a price to the public of $3.85 per share for an aggregate offering of $40,425,000 of common stock.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc., will present at the Citi 2012 Global Health Care Conference in New York City on Tuesday, February 28, 2012 at 9:30 a.m. Eastern Time.
Dyax Corp. (NASDAQ: DYAX) announced today that executive management will participate in two upcoming conferences.
Exelixis, Inc. (NASDAQ:EXEL) today announced the company’s lead compound, cabozantinib, is highlighted in a new peer-reviewed publication demonstrating that simultaneous inhibition of MET and VEGF signaling reduces tumor invasiveness and metastasis in preclinical models of pancreatic cancer.
GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on February 29, 2012 at the Citi 2012 Global Health Care Conference in New York.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the RBC Capital Markets’ Healthcare Conference on Wednesday, February 29, at 12:00 p.m. ET.
As larger pharmaceutical firms have shown an appetite for platform technology companies, shares for companies like PROLOR Biotech (NYSE Amex: PBTH), which possess access to platform technologies with broad-based applicability across a range of product types have been getting more attention from investors and watching their valuations increase.
SANUWAVE Health, Inc. (OTCBB: SNWV) has entered into a two-year exclusive distribution agreement with CAN-med Healthcare, a division of IMP Group Limited, to distribute the Company’s dermaPACE® device throughout Canada.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company’s business strategy will be given at two investor conferences.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the Citi 2012 Global Health Care Conference in New York. Lesley Russell Cooper, SVP, R&D Global Branded Products, will present on Monday, February 27, 2012.
Titan Medical Inc. ("the Company") (TSX VENTURE:TMD) (OTCQX:TITXF) announced that today the Company's common shares commenced trading on the international tier of the OTCQX market in the United States under the ticker symbol "TITXF".
One year after launching a national awareness campaign focused on the benefits of 90-day prescription refills at retail pharmacies, Walgreens (NYSE: WAG) (NASDAQ: WAG) today released new data supporting the success of the 90-day refill program and its over-arching benefits to patients and payers.