Intercept Pharmaceuticals Inc. shares ICPT,
More than 30% fell in pre-market trade on Monday, after the company said it received a full response letter from the U.S. Food and Drug Administration regarding its new request for drugs for treatment. for fibrosis caused by non-alcoholic steatohepatitis, or NASH. The letter says that based on data the regulator has reviewed to date, the expected benefit of the treatment, obeticholic acid, or OCA, is uncertain and does not sufficiently outweigh the potential risks to support accelerated approval. “The FDA recommends that Intercept submit additional efficacy and safety data from the post-provisional analysis of the ongoing REGENERATE study in support of possible accelerated approval and that the long-term results phase of the study continue,” the company said in a statement. . Intercept Chief Executive Officer Mark Pruzanski said he was disappointed by the FDA decision, which is “based on an apparently incomplete review, and without giving medical experts and patients the opportunity to be heard in advance by Adcom about the merits of OCA, which is a designated innovative Therapy “. The FDA “has progressively increased the complexity of histological endpoints, creating a very high bar that only OCA has hitherto achieved in a pivotal Phase 3 study,” he said. The company will seek a meeting with the FDA and hold a conference call with investors at 8:30 am EST. Shares fell 37% in the year through Friday, while the S&P 500 SPX,
It has fallen 7%.
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