Poor Idenix Pharmaceuticals
Being a next-generation drug, IDX19368 is further behind in the develop process. In fact, IDX19368 hasn't even been tested in humans.
Idenix isn't particularly less valuable if IDX19368 can't be developed; most of its potential is wrapped up in IDX184. But putting another drug on clinical hold is a further sign at how serious the FDA is taking BMS-986094's side effect issues. IDX184 and IDX19368 are both related to BMS-986094, which Bristol-Myers Squibb
The biotech thinks its drugs are different enough from BMS-986094 that they shouldn't have the same side-effect profile. But the only way to definitively prove that is by testing the drug in humans. For now, the FDA won't let Idenix do that directly -- thus the clinical hold -- so the company will have to use preclinical laboratory experiments to explain why BMS-986094 causes side effects and then prove its drugs won't have the same problem.
Interestingly, Bristol has offered its help in determining what's wrong with BMS-986094, which might make things a little easier, but investors shouldn't expect this to be a cakewalk.
If Idenix is able to emerge on the other side of the clinical-hold black hole, maybe Bristol would be interested in partnering with Idenix. Gilead Sciences
Ah, the joy of drug development.
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Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Gilead Sciences and Vertex Pharmaceuticals. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days. The Motley Fool has a disclosure policy.