Press release
Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Second Quarter 2023
― Screening closed for the Phase 3 REACH pivotal trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) ― ― Expect to report topline data for
About this update from Fulcrum Therapeutics, Inc.
[{"type":"text","content":"― Screening closed for the Phase 3 REACH pivotal trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) ― ― Expect to report topline data for REACH in the fourth quarter of 2024 ― ― Interactions continue with the U.S. Food and Drug Administration (FDA) to resolve clinical hold for FTX-6058 in sickle cell disease (SCD) ― ― Alan A. Musso appointed as chief financial officer ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the “Company”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today reported financial results for the second quarter of 2023 and provided a business update. “We are encouraged by the continued progress in the first half of 2023 and look forward to continuing to execute on our key priorities for our clinical programs,” said Alex C. Sapir, Fulcrum’s president and chief executive officer. “We closed screening for the Phase 3 REACH trial of losmapimod, and we expect to report topline data in the fourth quarter of 2024. This marks a critical milestone that brings us one step closer to potentially delivering the first FDA-approved therapy for the treatment of FSHD. In parallel, we continue to work diligently with the FDA to resolve the clinical hold for FTX-6058 as soon as possible.” Recent Business Highlights Screening is closed in the REACH Phase 3 pivotal trial evaluating losmapimod in FSHD at sites in the United States, Canada, and Europe. Fulcrum expects to complete enrollment in the third quarter of 2023 and expects to report topline data in the fourth quarter of 2024.In partnership with the FSHD Society, Fulcrum announced the launch of Project Mercury, a new global coalition to accelerate the delivery of new therapies for FSHD by uniting and mobilizing multiple sectors of the FSHD community, including advocates, patients, industry leaders, researchers, and clinicians. Fulcrum is the global and sustaining sponsor of Project Mercury.Interactions with the FDA to resolve the clinical hold for FTX-6058 are ongoing.Obtained an exclusive global license from CAMP4 Therapeutics Corp. (CAMP4) to acquire intellectual property arising from CAMP4’s pre-clinical research program in Diamond-Blackfan Anemia (DBA). Under th...