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2024-09-12 19:13
Fulcrum Therapeutics (NASDAQ:FULC) lost ~70% premarket Thursday after its lead program for protein kinase inhibitor, losmapimod, in-licensed from GSK (NYSE:GSK), failed to reach main goals in patients with a rare disorder called facioscapulohumeral muscular dystrophy (FSHD).
Citing topline data from its Phase 3 REACH trial, the Cambridge, Massachusetts-headquartered biotech said losmapimod failed to improve relative surface area compared to placebo, the study’s primary endpoint.
The results for secondary endpoints were also not statistically significant, the company announced, adding that however, the safety and tolerability profile of the experimental drug was in line with findings from its past trials.
Given the setback, Fulcrum (FULC) said it would suspend the losmapimod program in FSHD.
“As the largest interventional study ever completed in FSHD, we intend to share the full trial results with patients, study investigators, and the broader FSHD community to ensure others developing treatments for FSHD can benefit from these data,” Fulcrum’s medical chief Pat Horn added.