This section highlights FDA-related milestones and regulatory updates for drugs developed by Fulcrum Therapeutics (FULC).
Over the past two years, Fulcrum Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Losmapimod and pociredir. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Losmapimod (ReDUX4) - FDA Regulatory Timeline and Events
Losmapimod (ReDUX4) is a drug developed by Fulcrum Therapeutics for the following indication: Facioscapulohumeral muscular dystrophy (FSHD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Losmapimod (ReDUX4)
- Announced Date:
- September 12, 2024
- Indication:
- Facioscapulohumeral muscular dystrophy (FSHD)
Announcement
Fulcrum Therapeutics, announced that its Phase 3 REACH trial evaluating losmapimod in patients with FSHD, did not achieve its primary endpoint of change from baseline in RSA with losmapimod compared to placebo.
AI Summary
Fulcrum Therapeutics announced that its Phase 3 REACH trial for losmapimod in patients with facioscapulohumeral muscular dystrophy (FSHD) did not meet its primary endpoint. The study measured change from baseline in relative surface area (RSA), which reflects the reachable workspace, and the results showed no significant improvement for those treated with losmapimod compared to placebo. Secondary endpoints, like muscle fat infiltration and shoulder strength, also did not show meaningful differences between the groups.
Due to these disappointing results, Fulcrum has decided to suspend its losmapimod program for FSHD. The company expressed its deep disappointment over the trial outcomes and plans to complete a full evaluation of the data. Despite this setback, Fulcrum’s robust cash resources will support its ongoing efforts to develop treatments for other diseases with high unmet needs.
Read Announcement- Drug:
- Losmapimod (ReDUX4)
- Announced Date:
- September 9, 2024
- Indication:
- Facioscapulohumeral muscular dystrophy (FSHD)
Announcement
Fulcrum Therapeutics ahead of the company’s phase 3 losmapimod readout, expected by the end of October for Facioscapulohumeral muscular dystrophy (FSHD).
Read Announcement- Drug:
- Losmapimod (ReDUX4)
- Announced Date:
- May 8, 2024
- Indication:
- Facioscapulohumeral muscular dystrophy (FSHD)
Announcement
Fulcrum Therapeutics announced the publication of results from its Phase 2b clinical trial of losmapimod for the treatment of facioscapulopumeral muscular dystrophy (FSHD). The data are published in the peer-reviewed journal The Lancet Neurology.
AI Summary
Fulcrum Therapeutics has announced the publication of significant clinical trial results in The Lancet Neurology. The publication details findings from its Phase 2b clinical trial of losmapimod, a drug being studied for the treatment of facioscapulohumeral muscular dystrophy (FSHD), a condition that causes progressive muscle weakness in the face, shoulders, and upper arms.
The trial focused on evaluating both the safety and effectiveness of losmapimod in patients with FSHD. Early data shows promising potential for the drug to slow disease progression and help preserve muscle strength. The publication in this respected, peer-reviewed journal adds credibility to the findings and highlights a key step forward in developing treatments for FSHD. This announcement marks an important progress point for Fulcrum Therapeutics as they continue to advance research aimed at addressing the needs of those affected by this challenging condition.
Read Announcement- Drug:
- Losmapimod (ReDUX4)
- Announced Date:
- May 8, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Facioscapulohumeral muscular dystrophy (FSHD)
Announcement
Fulcrum Therapeutics, Topline data for the Phase 3 REACH clinical trial of losmapimod in FSHD expected during 4Q'24―
AI Summary
Fulcrum Therapeutics has announced that topline data from its Phase 3 REACH clinical trial will be available in the fourth quarter of 2024. The trial is studying losmapimod as a potential treatment for facioscapulohumeral muscular dystrophy (FSHD), a condition that causes progressive muscle weakness and wasting. Researchers hope the results will show if losmapimod can slow the disease’s progression and improve the quality of life for patients. This study is a key step in the effort to develop effective therapies for FSHD, and the forthcoming data will be closely watched by the medical community. The release of these findings could provide valuable insights into how well losmapimod works in treating FSHD and may influence future treatment plans for those suffering from this challenging condition.
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pociredir - FDA Regulatory Timeline and Events
pociredir is a drug developed by Fulcrum Therapeutics for the following indication: In sickle cell disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- pociredir
- Announced Date:
- May 29, 2025
- Indication:
- In sickle cell disease
Announcement
Fulcrum Therapeutics announced upcoming presentations at the 5th Global Congress on Sickle Cell Disease and the 2025 European Hematology Association Congress.
AI Summary
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company focused on rare genetic diseases, announced upcoming presentations at two major hematology conferences. At the 5th Global Congress on Sickle Cell Disease in Abuja, Nigeria (June 3-6, 2025), the company will share preclinical and early clinical data on pociredir, an oral drug aimed at increasing fetal hemoglobin for treating sickle cell disease. Two poster presentations will focus on both the drug's early results and the design of a Phase 1b, open-label study involving multiple doses in sickle cell patients.
Additionally, at the 2025 European Hematology Association Congress in Milan, Italy (June 12-15, 2025), Fulcrum will present findings from a Phase 1 study examining the pharmacokinetics, pharmacodynamics, and safety of pociredir in healthy adults and in animal models. Copies of these presentations will later be available on the company website.
Read Announcement- Drug:
- pociredir
- Announced Date:
- February 25, 2025
- Indication:
- In sickle cell disease
Announcement
Fulcrum Therapeutics, announced full year of 2024 as well as a business update.
AI Summary
Fulcrum Therapeutics reported its full year 2024 financial results along with an important business update. For 2024, the company ended the year with $241 million in cash, cash equivalents, and marketable securities, supporting a cash runway that extends at least into 2027. The business update highlighted progress on its lead program, pociredir, for treating sickle cell disease. The Phase 1b PIONEER trial is moving forward with strong momentum, having enrolled ten patients in the 12 mg dose cohort so far. Key clinical data is expected to be shared in mid-2025 for the 12 mg cohort and by the end of 2025 for the 20 mg cohort. This advancement signals potential for pociredir to increase fetal hemoglobin levels, which may offer a new oral treatment option and transform the management of sickle cell disease.
Read Announcement
