LPCN - Lipocine shares jump 9% after FDA Fast Track status for LPCN 1144 NASH treatment

The U.S. FDA has granted Fast Track Designation to Lipocine's (NASDAQ:LPCN) LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis (NASH). Shares up more than 9% premarket. LPCN 1144 was recently studied in the Liver Fat intervention with oral Testosterone ((LiFT )) Phase 2 paired biopsy clinical study in patients with confirmed NASH. The Fast Track program is designed to accelerate the development and expedite the review of products, which are intended to treat serious diseases and for which there is an unmet medical need. The status could also enable eligibility for Accelerated Approval and Priority Review if relevant criteria are met. NASH is a more advanced state of non-alcoholic fatty liver disease (NAFLD) and can progress to a cirrhotic liver and eventually hepatocellular carcinoma/liver cancer.

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Lipocine shares jump 9% after FDA Fast Track status for LPCN 1144 NASH treatment