Losmapimod

Sanofi reports 15.7% Q3 sales growth, driven by vaccine sales and strong business performance, raising 2024 EPS guidance. Dupixent sales up 23.8%, with full-year target confirmed at €13 billion. Pharma launches grew 67.1%, led by ALTUVIIIO, Nexviazyme, and Rezurock. Vaccines sales increased 25.5%, boosted by flu sales and Beyfortus. Opella sales rose 7.9%, supported by Qunol acquisition. R&D expenses grew 12.7%, while SG&A expenses grew 6.4%. Business EPS at €2.86, up 12.2% reported and 17.6% at CER. Four regulatory approvals and four positive phase 3 data readouts achieved. Negotiations underway to transfer a controlling stake of Opella to CD&R. 2024 business EPS guidance upgraded to low single-digit growth at CER.

Losmapimod, an investigational medication from Fulcrum Therapeutics, failed to significantly outperform a placebo in improving upper limb function and other clinical measures in people with facioscapulohumeral muscular dystrophy (FSHD) in the REACH Phase 3 trial. The company plans to stop developing losmapimod and focus on other clinical programs.

Moderna revised its break-even forecast from 2026 to 2028, leading to significant R&D cuts and a downgrade in stock ratings by firms like Jefferies and J.P. Morgan. The company plans to focus on 10 pipeline candidates, halting development of five programs, and expects a compounded annual growth rate of over 25% from 2026 to 2028.

Fulcrum Therapeutics' stock dropped >60% after its Phase 3 REACH trial for losmapimod, a potential FSHD treatment, missed its primary endpoint, leading to the suspension of the program.

Fulcrum Therapeutics' experimental drug losmapimod failed a Phase 3 trial for muscular dystrophy FSHD, leading to suspension of its development. Despite positive signs in previous tests, losmapimod missed its main objective and secondary goals. Fulcrum's shares dropped 60%, and the company will focus on its sickle cell disease treatment, expecting Phase 1 data next year. The FDA previously suspended testing of the sickle cell therapy for six months.

Losmapimod failed to improve reachable workspace (RWS) in FSHD patients at week 48, leading Fulcrum to suspend its development. Despite this, Fulcrum maintains a robust cash position to advance other therapies, including pociredir for sickle cell disease.