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Intercept Pharmaceuticals (NASDAQ:ICPT) said it is halting investment its drug development program for nonalcoholic steatohepatitis, or NASH, after receiving negative feedback on its market application for its NASH drug candidate obeticholic acid.
The biotech company said that the FDA concluded after a review the application that it could not be approved in its present form. Intercept added that the company would have to successfully complete a long-term outcomes phase for its Phase 3 study for the drug, at minimum, for it to be approved. Intercept had been seeking to have the product approved for the treatment of pre-cirrhotic fibrosis due to NASH.
As a result of the FDA’s feedback, Intercept said it was ending all further investment in its NASH program and restructuring its operations to focus on rare and serious liver diseases. It added that it plans to “drive an accelerated plan to profitability beginning in 2024.”
The company plans to hold a conference call with investors on Friday to further discuss the move and issue updated financial guidance.
In addition to NASH, Intercept has been developing drugs for the rare liver disease primary biliary cholangitis. The company markets an obeticholic acid therapy for the disease called Ocaliva.
More on Intercept Pharmaceuticals:
Drug pricing watchdog raises alarm over upcoming liver disease meds
Intercept crashes 29% after FDA AdCom snub for liver disease therapy
Intercept fails to win FDA panel backing for NASH drug (updated)
Intercept Pharmaceuticals: Do Not Expect PBC Sales To Save The Company
Intercept Faces Setback On NASH Approval: Unpacking The ADCOM Decision And Its Implications
