Intercept Touts a Smaller Piece of Its NASH Trial at Liver Conference
Summary
Intercept Pharmaceuticals (NASDAQ: ICPT ) said today it was on track to ask US and European regulators this year to approve what could be the first drug for an advanced liver disease that poor diet and exercise habits have turned into a quiet epidemic . In an interview Thursday, Intercept’s SVP of medical affairs Gail Cawkwell confirmed that Intercept will submit OCA for approval later this year. Intercept used this week’s meeting to unveil an analysis of a subset of the REGENERATE study, about 70 percent of the 931 enrolled patients, faring better than the full set. The smaller group counted those who reached 18 months of treatment and received a follow-up liver biopsy, an important milestone for trial investigators to measure a patient’s progress. “There is significant unpredictability in determining which patients progress on the disease versus those that actually regress over time,” wrote SVB Leerink analyst Pasha Sarraf in a note to investors.
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