Shares of Fulcrum Therapeutics, Inc. (NASDAQ: FULC) plunged 61.1% on Sept. 12 after the company announced disappointing top-line data from the phase III REACH study, which evaluated its pipeline candidate, losmapimod, for treating patients with facioscapulohumeral muscular dystrophy (FSHD), a rare and debilitating disease.
Currently, there are no treatments approved for the given indication.
The study did not meet its primary endpoint as treatment with losmapimod failed to demonstrate a change from baseline in relative surface area (RSA), a measure of reachable workspace (RWS), compared with placebo at week 48.
The study also failed to achieve nominal statistical significance on the secondary endpoints.
Year to date, shares of Fulcrum have plunged 49% compared with the industry's decline of 0.8%.
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Data From FULC's REACH study
Data from the REACH study showed that treatment with losmapimod led to a 0.013 improvement in RSA compared to a 0.010 improvement in RWS for patients who received a placebo at ...
