Fulcrum Therapeutics laid off the majority of its workforce and discontinued development of pociredir for sickle cell disease following an FDA-raised benefit-risk concerns. The company’s SEC filing described reductions from 57 to nine full-time employees, with expected layoffs in Q2. Fulcrum said the FDA concluded that pharmacological interventions targeting the PRC2 complex carry an equivalent malignancy risk—linking the decision to safety signals associated with Ipsen’s tazemetostat (Tazverik). The biotech said it is now seeking strategic alternatives. This is another high-profile example of how postulated class effects and confirmatory safety history can change development feasibility even when mechanistic rationale remains intact.
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