Biopharma · FDA Approvals · Stock
Fulcrum Therapeutics Inc is a clinical-stage biopharmaceutical company focused on developing small molecules for genetically defined rare diseases. Its product candidate, Pociredir, is an oral small molecule designed to induce fetal hemoglobin (HbF) and is in clinical development for sickle cell disease (SCD). The comp…
Assets on file: pociredir
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pociredir · NCT07401823 registry update
status: ENROLLING_BY_INVITATION → TERMINATED; primary_completion: 2030-02-04 → 2026-06-04; completion: 2030-07-05 → 2026-07-02; enrollment: 50 → 1; why_stopped: → Sponsor Decision
FULC: Pociredir 20 mg cohort data update planned for Q1 2026
Fulcrum announced that updated results from the 20 mg cohort of the Phase 1b PIONEER trial will be released in Q1 2026. The company also plans an End-of-Phase 2 meeting with the FDA in 1H 2026 and initiation of the next study in 2H 2026.
FULC: Pociredir 20 mg cohort shows 9.9% HbF rise at Week 6 in PIONEER SCD trial
Fulcrum reported initial Phase 1b PIONEER results for the 20 mg cohort of pociredir in sickle cell disease, demonstrating a clear dose-response with mean absolute HbF increasing 9.9% at Week 6 versus 5.6% in the 12 mg cohort. 58% of patients reached HbF ≥20% at Week 6, and >3.75-fold HbF induction was observed at Week 12. Pociredir remained generally well-tolerated with no treatment-related serious adverse events.
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