Lipocine Gets FDA Fast-Track Designation for LPCN 1144 in Non-Cirrhotic NASH

 

Lipocine Inc. on Thursday said the U.S. Food and Drug Administration granted fast-track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis, a chronic liver condition commonly known as NASH. The Salt Lake City, Utah, clinical-stage biopharmaceutical company said LPCN 1144 showed improvement of liver injury markers with no observed tolerability issues in a Phase 2 study. The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs. Lipocine said it believes the designation will enable the company to work closely with the FDA on its development program for NASH, including the design of a Phase 3 program. https://www.marketscreener.com/quote/stock/LIPOCINE-INC-16085349/news/Lipocine-Gets-FDA-Fast-Track-Designation-for-LPCN-1144-in-Non-Cirrhotic-NASH-36901409/