FDA to release conditions for approving COVID-19 vaccine--WSJtop male enhancements online


Intercept Pharmaceuticals Inc. shares tumbled more than 30% in premarket trade Monday, after the company said it has received a U.S. Food and Drug Administration Complete Response Letter regarding its New Drug Application for a treatment for fibrosis caused by nonalcoholic steatohepatitis, or NASH. The letter says that based on the data the regulator has reviewed to date, the predicted 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 post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue," the company said in a statement. Intercept Chief Executive Mark Pruzanski said he was disappointed by the FDA decision, which is "based on an apparently incomplete review, and without having provided medical experts and patients the opportunity to be heard at the anticipated Adcom on the merits of OCA, which is a designated Breakthrough Therapy." The FDA has "progressively increased the complexity of the histologic endpoints, creating a very high bar that only OCA has so far met in a pivotal Phase 3 study," he said. The company will seek a meeting with the FDA and will hold a conference call with investors at 8.30 a.m. Eastern Time. Shares have fallen 37% in the year through Friday, while the S&P 500 has fallen 7%.