Shares of Intercept Pharmaceuticals Inc. ICPT tumbled 15.2% toward an 11-month low in premarket trading Monday, after the biopharmaceutical company said a U.S. Food and Drug Administration committee voted to “defer approval” for its treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The company said 15 of 16 FDA committee members voted to defer approve until clinical outcome data from a trial are submitted and reviewed, and 12 of 16 members voted “no” on the question of whether current efficacy and safety data suggests benefits of the treatment (OCA 25 milligram) outweigh risks in NASH patients. “We are disappointed in the outcome of today’s meeting,” said Intercept Chief Executive Officer Jerry Durso. “We continue to disagree with the FDA on certain characterizations of OCA’s efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests (NITs), as discussed in today’s meeting.” Intercept’s stock has gained 9.6% year to date through Friday, while the iShares Biotechnology exchange-traded fund IBB has slipped 0.9% and the S&P 500 SPX has gained 9.2%.
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