- In an update to investors, Intercept Pharmaceuticals (NASDAQ:ICPT) announces that it has changed the protocol, based on discussion with the FDA, in its Phase 3 REGENERATE study that should accelerate its completion and enhance the prospects for a positive outcome.
- The changes include a new primary endpoint of fibrosis improvement or NASH resolution (previously both) and a reduction in target enrollment to 750 subjects from ~2,000 (to be completed mid-year).
- Shares are up 11% premarket on robust volume.
Shortened timeline for Intercept's late-stage study of OBA in NASH stokes investors, shares up 11% premarket
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Intercept Pharmaceuticals, Inc. |