Skip to Content

FDA Has Safety Concerns Over Biocryst's Hep C Drug

Associated Press - Oct. 31, 2012

RESEARCH TRIANGLE PARK, N.C. -- Shares of drug maker BioCryst Pharmaceuticals Inc. plunged Wednesday after the company said it was withdrawing its regulatory application for a hepatitis C drug due to potential safety risks.

BioCryst said the Food and Drug Administration has concerns about the toxicity of its experimental antiviral treatment, BCX5191, for treating patients with hepatitis C. The drug maker said it plans to test lower doses of the drug "that are not associated with toxicity in animals." The company said it will then determine whether to continue development of the drug.

In August, Bristol-Myers Squibb Co. scrapped a potential hepatitis C treatment after a patient participating in a test of the drug died of heart failure. The New York company said it decided to discontinue development of BMS-986094, in the interest of patient safety.

Shares of BioCryst Pharmaceuticals Inc. fell $1.26, or 30.9 percent, to $2.82.

Posted: November 2012