Intercept set to meet with FDA in July about NASH drug

Shares of Intercept Pharmaceuticals Inc. were up 2.2% in premarket trading on Monday after the company said a meeting with the Food and Drug Administration to discuss resubmitting an application for its experimental nonalcoholic steatohepatitis drug was moved to July from June. Intercept said it plans to share new topline data about the investigational drug in July. That data will also be provided to the regulator in advance of the meeting. “We see this as a minor delay from a timing standpoint,” SVB Securities analyst Thomas Smith told investors on Monday. He also describd the recent departure of Gail Cawkwell, SVP of medical affairs, safety, and pharmacovigilance, as “suboptimal timing and likely to be interpreted as an incremental negative by some investors ahead of imminent key NASH data and regulatory updates.” Intercept’s stock is up 0.5% this year, while the S&P 500 has declined 13.8%.

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