BRIEF-Idenix Pharma says got FDA letter on hepatitis C product IDX19368

Related:

On August 27 Idenix: Places IDX19368 on Clinical Hold

A clinical hold was placed on IDX19368, after the FDA verbally informed Idenix of concerns related to serious heart issues seen in Bristol-Myers - BMS-986094. On August 23 Bristol-Myers discontinued the phase II trial after one patient died, also nine patients were hospitalized and two remained hospitalized.

 

Released Today

BRIEF-Idenix Pharma says got FDA letter on hepatitis C product IDX19368

 

Sept 20 (Reuters) - Idenix Pharmaceuticals Inc :

* Says received formal FDA letter related to IDX19368 - SEC filing

* Says FDA requested additional toxicology and metabolism preclinical studies on IDX19368

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