Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral liver diseases, today announced an update on the timing of its pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the potential resubmission of its nonalcoholic steatohepatitis (NASH) New Drug Application (NDA) based on an interim analysis of the REGENERATE trial in patients with fibrosis due to NASH. The pre-submission meeting, previously scheduled in June, has been moved to July following a recent request from the FDA that topline data from REGENERATE be provided to the agency for its review prior to the meeting.
Intercept anticipates that topline data from REGENERATE will be available and made public in July.
https://finance.yahoo.com/news/intercept-provides-nash-regulatory-timeline-103000629.html
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