Intercept Pharmaceuticals (ICPT) Bullish View Reiterated at Needham & Company on Positive Positive Phase 3 REGENERATE NASH Trial
Needham & Company analyst Alan Carr reiterated a Buy rating and $150 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) after the company announced this morning that one of the two primary endpts of the Phase 3 REGENERATE trial in F2/F3 NASH was met w/ the highest dose tested (25mg QD Obeticholic Acid).
Carr reminds clients that only one of the endpoint reportedly needed to be met per company discussions with the FDA.
"A greater proportion of pts in the 25mg arm experienced improvement in fibrosis w/ no worsening of NASH than in pbo arm (23.1% vs. 11.9% p=0.0002)," Carr notes. "There was clear evidence of antifibrotic activity in the low dose 10mg arm and in the large exploratory pt population that included F1-3 NASH, however, the high statistical hurdle was not met. A general trend in favor of NASH resolution, the other primary endpt, was observed w/ 10mg and 25mg OCA. No apparent surprises in safety data. Mgmt guided for US/ EU regulatory submissions 2H19. OCA appears on track to be first drug approved for NASH. Phase 3 results suggest OCA likely to be important antifibrotic monotherapy in the near term and has potential to be part of combination therapy in the long-term."
Shares of Intercept Pharmaceuticals closed at $110.82 yesterday.