BofA Securities has shown confidence in Fulcrum Therapeutics (FULC) by upgrading the stock from Underperform to Neutral. This move comes ahead of the company’s anticipated Phase 3 readout for losmapimod, a potential treatment for Facioscapulohumeral muscular dystrophy (FSHD), a rare genetic muscle disease affecting facial muscles, shoulders, upper arms, and lower legs. The analyst raised the price target from $5 to $10, reflecting an increased likelihood of success (LOS) from 35% to 50%.
The optimism stems from positive feedback from key opinion leaders (KOLs) who are encouraged by the functional benefits observed in Phase 2 trials using the ‘reachable workspace’ (RWS) endpoint. RWS measures upper extremity function, and the KOLs believe it accurately tracks disease progression. They see stabilization of RWS in Phase 3 as clinically significant and anticipate that replicating the Phase 2 results—showing a 10% placebo-adjusted change at 48 weeks—would be a positive outcome.
Despite the optimistic outlook, the analyst acknowledges uncertainty about the study’s success due to the unpredictability of the control arm’s response. The analyst emphasizes that they await the Phase 3 readout to further de-risk the program and notes that the pociredir story in sickle cell disease (SCD) continues to be a stock overhang.
Losmapimod is poised to become the first treatment for FSHD, but it may face future competition from Avidity Biosciences Inc. (RNA) and Roche Holdings AG (RHHBY), which are further behind in development. FULC stock is up 1.30% at $8.651 at last check Monday.
