Intercept (ICPT) NASH Study to be Larger, Riskier and Delayed, Leerink Partners Says
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Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH
May 19, 2015 6:00 AM EDT-Key features of the REGENERATE Phase 3 trial in non-cirrhotic NASH with liver fibrosis finalized pursuant to consultations with FDA and EMA
-REGENERATE trial design intended to support initial approval on interim 72-week histology endpoint and full approval on liver-related outcomes endpoint
-Conference Call Scheduled Tuesday, May 19 at 8:00 a.m. ET
NEW YORK, May 19, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) (Intercept) today announced its plans for an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic... More
