Idenix looks to Plan B as FDA hep C review plods on
A year ago, Idenix ($IDIX) was one of the hottest biotechs in the industry. With rival hep C drug developers getting snapped up for huge premiums, all eyes were on IDX184, a "nuc" that could help revolutionize treatment standards. Then Bristol-Myers Squibb's ($BMY) somewhat similar BMS-094 program went up in flames after the death and injury of several patients, the FDA put a hold on Idenix work--including IDX19368--and the biotech has been in limbo ever since.
Now Idenix, which had hoped to answer regulators' safety queries and move on, says the FDA wants more time to study the drugs and the implications of the 094 disaster before it makes a decision on the future of the two drugs. An FDA response is expected by the end of March, but execs at the Cambridge, MA-based Idenix told investors at the J.P. Morgan confab this week that they may end up shelving the treatments and move on with other drugs in the pipeline, according to a report from Bloomberg.
Idenix says it's been busy advancing new "nucleotides" without the safety baggage through proof-of-concept studies and has an NS5A drug in the works that can be paired with it. "We feel very good about our ability to combine the NS5A in the first half, get that data, and be on track for the fourth quarter to combine our own nuc with our own NS5A," CEO Ron Renaud told the business wire. "It's a semi-reset."
But that's not the news that investors were hoping to hear. Idenix's share price slid on the company's backup plan.
- here's the Bloomberg report
Idenix craters as clinical hold spurs tox jitters for hot hep C drug
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Idenix drops after FDA loosens one hold but slaps on another
Idenix shares crash after tox scare forces hold on hep C drugs