Keros Therapeutics Announces ALS Trial Collaboration and Presents New Phase 1 Data

KROS
March 09, 2026

Keros Therapeutics announced a partnership with the Sean M. Healey & AMG Center for ALS at Mass General Brigham to design a Phase 2 clinical trial of its lead candidate rinvatercept in amyotrophic lateral sclerosis (ALS) patients. The collaboration leverages the Center’s biomarker‑driven, personalized trial platform to identify ALS subgroups most likely to respond to rinvatercept’s myostatin and activin‑A inhibition, marking the first formal clinical partnership for the drug beyond its Duchenne muscular dystrophy (DMD) program.

In addition, Keros presented further Phase 1 data from its rinvatercept study at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference. The data confirm target engagement, safety, and favorable pharmacokinetics in healthy volunteers, supporting the company’s plan to advance rinvatercept into two Phase 2 trials—one in DMD and the other in ALS.

"We are pleased to present additional data that further underscore the wide‑ranging therapeutic potential of rinvatercept. These data continue to reinforce the potential of rinvatercept to treat neuromuscular diseases, and our focus remains on advancing the rinvatercept program into two Phase 2 clinical trials, one in Duchenne muscular dystrophy (“DMD”) and one in amyotrophic lateral sclerosis (“ALS”)." – Jasbir S. Seehra, President and Chief Executive Officer of Keros.

The announcement follows Keros’ FY 2025 financial results, which showed a net income of $87.0 million—a turnaround from a $187.4 million loss in FY 2024—largely driven by license revenue from Takeda. The company ended 2025 with $287.4 million in cash and cash equivalents, providing a substantial buffer to fund ongoing development.

Market reaction to the announcement was mixed, reflecting the contrast between the positive clinical news and a recent Q4 earnings miss that included a revenue decline and analyst guidance revisions. Investors weighed the potential of rinvatercept against near‑term financial headwinds, resulting in a nuanced response to the news.

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