FDA, Clinical Trial News: $ABIO, $GENZ, $KV-A, $SLXP

pillsmoneyBy Mike Havrilla, mikehavrx.com

Shares of ARCA Biopharma (NASDAQ:ABIO) are soaring today on news of an issued patent that includes the methods of treating heart failure patients with Gencaro (bucindolol) based on genetic testing. ABIO also reported that it has submitted a revised pivotal study protocol to the FDA on 3/25/10 under the SPA process and could begin the study in approximately one year, contingent upon the FDA response and adequate funding.

Shares of Genzyme (NASDAQ:GENZ) are rebounding today following a drop of approximately 10% for the week on news earlier this week that the FDA will enforce plant operation inspections at the Company’s Allston facilities (impacting key drugs Cerezyme and Fabrazyme). GENZ reported that the FDA enforcement action will likely result in a consent decree, whereby a third-party would inspect and review the Company’s progress to regain FDA compliance.

An SEC 10-K filing on 3/25/10 indicates that KV Pharma (NYSE:KV-A) does not anticipate resuming shipping of its generic drug products until 4Q10 at the earliest as it works to regain FDA compliance and maintain / increase its financial resources.

On Wednesday, Salix Pharma (NASDAQ:SLXP) announced that it received FDA approval for Xifaxan 550mg for hepatic encephalopathy (HE). The Company is also seeking to expand the product label for Xifaxan to include the treatment of patients with non-constipation irritable bowel syndrome (IBS) and expects to file this NDA by June 2010 based on the results of its pivotal Phase 3 TARGET studies that are scheduled for presentation at the Digestive Disease Week (DDW) meeting in early May.

mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed HavRx Regulatory Catalyst Index. Please visit www.mikehavRx.com for more details.

Disclosure: No positions

The comments are closed.