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On Friday, FDA's Gastrointestinal Drugs Advisory Committee voted 12 to 2—with two abstentions—that the benefits of Intercept Pharmaceutical Inc's ICPT Ocaliva 25 mg, also known as Obeticholic acid (OCA), don't outweigh the risks in nonalcoholic steatohepatitis (NASH) patients with stage 2 or 3 fibrosis.
HC Wainwright has downgraded the stock to Sell from Neutral based on: OCA is either never approved for NASH or is approved in ~ four years on (still) marginal benefit-risk and is a commercial failure;
The management decides soon after the CRL to abandon the program altogether, terminate the LT outcomes study and all ancillary R&D work on OCA in NASH, and concurrently announce a cost-cutting reorganization;
Sales of Ocaliva for PBC continue to grow in the low-to-mid teens % this year and in 2024 (peak year) before it LOE in September 2031 or it faces competition from CymaBay Therapeutics Inc's (NASDAQ:CBAY) seladelpar, Ipsen SA's (OTC:IPSEY) (OTC:IPSEF)/ Genfit SA's (NASDAQ:GNFT) elafibranor—enter the market by 1Q25.
Even if approved, the analyst says it is unlikely to be commercially successful, especially considering a potentially far superior option, DURECT Corp's (NASDAQ:DRRX) larsucosterol.
Price Action: ICPT shares closed down by 29.7% at $9.53 on Monday.
