Idenix Pharma slumps as FDA calls for more data on IDX20963

USA-based biotech firm Idenix Pharmaceuticals (Nasdaq: IDIX) saw its share price plunge as much as 31.8% to $3.50 in heavy volume last Friday (June 21), after it announced it has received verbal communication from the Food and Drug Administration requesting additional preclinical safety information for IDX20963, the company’s lead uridine nucleotide prodrug candidate, under development as a potential treatment for hepatitis C.

Initiation of clinical trials for IDX20963 is on hold and the company must provide a satisfactory response to the FDA before clinical trials can begin in the USA. As a result, the company anticipates a delay in the initiation of the clinical program for IDX20963 while it responds to the FDA's comments. Idenix recently submitted an Investigational New Drug (IND) application for IDX20963 to the FDA, including preclinical data demonstrating potent, pan-genotypic activity.

Idenix is among companies including AbbVie Inc (NYSE: ABBV) and Gilead Sciences (Nasdaq: GILD) seeking new drugs for the viral disease that attacks the liver and affects an estimated 170 million people worldwide. Analysts estimate the market for such new drugs is $20 billion, says Bloomberg.