ICPT - Intercept gains as NASH candidate goes under FDA review

• Intercept Pharmaceuticals ( NASDAQ: ICPT ) added ~2% pre-market Thursday after announcing that the FDA accepted its marketing application for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
• The regulator has assigned June 22, 2023, as the target action date as the company seeks accelerated for the New Drug Application (NDA).
• The NDA is backed by two Phase 3 interim readouts from Intercept’s ( ICPT ) REGENERATE, which is currently underway with 2,480 patients, testing two doses of OCA at 10 mg and 25 mg daily.
• “We believe OCA has the potential to become an important therapy given its strong and direct antifibrotic effect, and we look forward to continuing our work with FDA over the coming months as they review our NDA,” Chief Executive Jerry Durso remarked.
• Intercept ( ICPT ) “was the long-time front-runner for the NASH market,” until the FDA rejected OCA for NASH in 2020, Seeking Alpha contributor Clinically Sound Investor wrote in November.

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