Fulcrum : FDA Grants Fast Track Designation To Losmapimod For Potential FSHD Treatment

Fulcrum Therapeutics Inc. (FULC) said Wednesday that the U.S. Food and Drug Administration has granted Fast Track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy or FSHD.

In Wednesday pre-market trading, FULC was trading at $10.64 up $0.20 or 1.92%.

Fast Track Designation is intended to facilitate development and expedite the review of drugs that treat serious conditions so an approved product can reach the market expeditiously.

Fulcrum said it is on track to report full data from ReDUX4, a Phase 2b randomized, double-blind, placebo-controlled trial of losmapimod in facioscapulohumeral muscular dystrophy patients, at the virtual facioscapulohumeral muscular dystrophy International Research Congress taking place June 24-25, 2021.

Fulcrum is currently conducting Phase 2 trials investigating the safety, tolerability, and efficacy of losmapimod to treat the root cause of facioscapulohumeral muscular dystrophy.

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