UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
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| Item 8.01 | Other Events |
On September 12, 2024, Fulcrum Therapeutics, Inc., or Fulcrum, issued a press release announcing topline results from its Phase 3 REACH clinical trial of losmapimod in facioscapulohumeral muscular dystrophy, or FSHD. As announced, Fulcrum’s Phase 3 REACH trial did not achieve its primary endpoint of change from baseline in relative surface area with losmapimod compared to placebo. In addition, secondary endpoints did not achieve nominal statistical significance. The safety and tolerability profile of losmapimod was consistent with previously reported studies.
A copy of the press release is filed as Exhibit 99.1 hereto and incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Press release dated September 12, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| FULCRUM THERAPEUTICS, INC. | ||||||
| Date: September 12, 2024 | By: | /s/ Alex C. Sapir | ||||
| Name: | Alex C. Sapir | |||||
| Title: | President and Chief Executive Officer | |||||