Fulcrum Therapeutics Receives Termination Notice from Sanofi Ending Collaboration Agreement for Losmapimod

Fulcrum Therapeutics, Inc. (NASDAQ: FULC) recently disclosed in an 8-K filing that it received written notice from Genzyme Corporation, a Sanofi subsidiary, regarding the termination of their collaboration and license agreement dated May 11, 2024. This agreement granted Sanofi certain intellectual property rights to commercialize losmapimod, an oral small molecule designed for treating facioscapulohumeral muscular dystrophy (FSHD) outside the United States.

The termination notice, received on December 18, 2024, specifies that the agreement will end for convenience, with the termination becoming effective on April 17, 2025, following 120 days from the receipt of the notice by Fulcrum. Until the termination date, both parties will continue fulfilling their respective obligations as outlined in the agreement. Ultimately, once terminated, Fulcrum will cease to receive further milestone payments, royalties, or reimbursement for global development costs.

The collaboration entailed Fulcrum conducting Phase 3 clinical trials for losmapimod under a mutually agreed global development plan, sharing global development costs equally with Sanofi. Sanofi held the rights to conduct certain development activities primarily aimed at regulatory approval outside the U.S., while Fulcrum maintained sole manufacturing rights for its activities and commercialization within the United States.

As per the agreement terms, Sanofi initially made an $80 million upfront payment to Fulcrum, with the potential for up to an additional $975 million in specified regulatory and sales-based milestones. Furthermore, Fulcrum was slated to receive royalties ranging from the low-teens to the mid-twenties based on net sales of losmapimod outside the U.S., payable on a product-by-product basis within a specified royalty term.

The complete details of the terminated agreement can be referenced in the exhibit attached to Fulcrum’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2024.

Following the termination notice, Fulcrum Therapeutics is set to move forward beyond the agreement with Sanofi, adhering to the terms outlined in the termination notice.

This filing was made as required by Item 1.02 of Form 8-K, notifying shareholders and stakeholders of this significant development in Fulcrum Therapeutics’ business operations.

For further details and information, interested parties are encouraged to refer to the official filings available on the Securities and Exchange Commission website.

The Financial Statements and Exhibits under Item 9.01 of the filing pertain to the details of the terminated agreement and related financial disclosures.

This news piece serves as a factual representation of the recent development concerning Fulcrum Therapeutics and Sanofi’s collaboration termination for losmapimod.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Fulcrum Therapeutics’s 8K filing here.

Fulcrum Therapeutics Company Profile

Fulcrum Therapeutics, Inc, a clinical-stage biopharmaceutical company, focuses on developing products for improving the lives of patients with genetically defined diseases in the areas of high unmet medical need in the United States. Its product candidates are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy is under phase III clinical trial; and pociredir, a fetal hemoglobin inducer for the treatment of sickle cell disease and beta-thalassemia is under phase I clinical trial.