|VIVUS falls on obesity drug safety concerns. EU rejects Acorda MS drug. After the Bell: Clinical Data gets FDA approval, shares soar|
|By Mary Davila|
|Friday, 21 January 2011 20:18|
After the bell, shares of Clinical Data, Inc. (NASDAQ:CLDA) surged briefly before being halted, after the FDA approved the company's antidepressant drug, vilazodone. The drug will be marketed under the brand name Viibyrd and has the potential to reach blockbuster status. The drugs dual mechanism of action and positive side effect profile could help the drug compete in a crowded field. In clinical trials, vilazodone had minimal impact on sexual desire and other undesirable side effects seen in anti-depressants such as weight gain.
In extended trading, shares of Clinical Data were up $2.21 or 15% to $17.24 before being halted. It is anticipated that shares will open much higher when the stock resumes trading on Monday. It has been speculated that the company could be a takeover target by a major pharma company as many patents for existing anti-depressant drugs are set to expire in the next couple of years.
Shares of VIVUS, Inc. (Nasdaq:VVUS) were under pressure Friday. The company announced that the FDA has expressed concerns with the company's investigational drug, Qnexa, for obesity. The agency raised concerns regarding the potential for birth defects in pregnant woman. The FDA wants Vivus to conduct a feasibilty study to analyze existing data to see if the historical incidence of oral cleft, also known as cleft lip, in babies of woman treated with topiramate. Vivus's Qnexa is a combination of topiramate, typically used for seizures and migraines, and another drug, phentermine.
The stock fell sharply as investors worried that the analysis could take 5 or 6 months to complete. Shares ended the day at $8.74, down $1.69 or 16%.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) fell Friday after it was reported that the European Medicine Agency's Committee for Medicinal Products for Human Use rejected the company's multiple sclerosis drug. The drug, Famprya, is already approved in the US and marketed under the name Ampyra. The drug, which is prescribed to improve the walking ability in MS patients, was said by the EU to have had little effect on walking speed improvement and that the effect on speed could not be linked to improvements such as better balance, coordination or stamina.
Shares fell $3.86 or 14% to $23.97.
Fresh Start Private (OTCBB: CEYY) , a leader in the alcohol treatment and rehabilitation industry, today announced that it has signed a contract with Merit Management Services, LLC (Merit) to open up to five Fresh Start Private (FSP) Treatment Centers within the next twelve months.
Genomic Health, Inc. (Nasdaq: GHDX) today announced presentation of three studies at the American Society of Clinical Oncology® (ASCO®) (1) Gastrointestinal (GI) Cancer Symposium, including one finding that high tumor grade was not a marker of higher recurrence risk in stage II colon cancer, suggesting that other markers, such as the Oncotype DX® Recurrence Score® (RS) test as well as T-stage and mismatch repair (MMR) status, should be considered by physicians during the treatment decision-making process.