{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-310509","form_type":"8-K","ticker":"FULC","cik":"0001680581","company_name":"Fulcrum Therapeutics, Inc.","filed_at":"2025-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.132722+00:00","generated_at":"2026-05-16T13:59:00.475017+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Fulcrum reports positive Phase 1b data for pociredir in SCD: 58% patients achieved HbF>=20% at 20 mg dose","bullets":["Mean absolute HbF increased 9.9% at Week 6 in 20 mg cohort (vs 5.6% in 12 mg); 7 of 12 patients (58%) achieved HbF ≥20%.","Clear dose-response: >3.75-fold mean HbF induction at Week 12 (n=6) vs 2.4-fold in 12 mg cohort.","Hemolysis markers improved at Week 6: indirect bilirubin -37%, LDH -37%, reticulocyte counts -33%.","Pociredir well-tolerated with no treatment-related SAEs or discontinuations; dosed in 148 adults to date.","Plans to submit IND for bone marrow failure syndromes (e.g., Diamond-Blackfan anemia) in Q2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-310509","json":"https://secwatch.observer/filing/0001193125-25-310509.json","markdown":"https://secwatch.observer/filing/0001193125-25-310509.md","text":"https://secwatch.observer/filing/0001193125-25-310509.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1680581/000119312525310509/0001193125-25-310509-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1680581/000119312525310509/fulc-20251208.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:59:00.475017+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}