By Chris Wack


Hepion Pharmaceuticals Inc. said the U.S. Food and Drug Administration has granted Fast Track designation for its lead drug candidate, CRV431, for the treatment of non-alcoholic steatohepatitis.

The FDA Fast Track designation allows sponsors to gain access to expedited drug approval reviews for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need. The program is also designed to facilitate drug development by making provisions for more frequent meetings with the FDA to discuss drug development plans, and Fast Track designation can lead to Accelerated Approval and/or Priority Review eligibility if certain criteria are met.

The biopharmaceutical company said that administered once daily as an oral soft gel capsule, CRV431 has been well-tolerated and has shown signals of efficacy in NASH in an early Phase 2 study. It plans to start a larger Phase 2b NASH study in biopsy confirmed F2 and F3 NASH subjects in the coming months.

Hepion shares were up 9% to $1.35 in premarket trading.


Write to Chris Wack at


(END) Dow Jones Newswires

November 30, 2021 08:31 ET (13:31 GMT)

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