19 March 2026
Overnight, Roche has shared with the FSHD community that it will discontinue its Phase II MANOEUVRE trial GYM329 or RO7204239 in Facioscapulohumeral Muscular Dystrophy (FSHD).
While disappointing, particularly for participants and clinical teams, this is a normal part of therapeutic development. Each study, regardless of outcome, advances our understanding and moves the field forward.
Importantly, this does not change the momentum in FSHD. The global pipeline remains strong and increasingly diverse, with multiple programs targeting the root cause of disease, alongside therapies designed to preserve muscle function and improve quality of life. Each trial, successful or not, brings us closer to effective treatments.
At FSHD Global, we remain focused on accelerating clinical trial readiness and ensuring equitable patient access.
We thank all trial participants and investigators for their invaluable contribution.
The work continues.
Frequently Asked Questions
What was the MANOEUVRE Phase II study?
The MANOEUVRE Phase II clinical study was set up to assess the safety, effectiveness, tolerability, and biological activity of emugrobart an investigational antibody that targets myostatin as a potential treatment for people aged 18–65 living with FSHD.
Why was the MANOEUVRE study stopped? Were there any safety concerns?
The decision to stop the MANOEUVRE Phase II study was not related to any safety concerns. Emugrobart was well tolerated by participants, with no serious side effects reported and no patients withdrawing from treatment as a result.
The study was discontinued after a thorough review of the results, which indicated that emugrobart did not reliably improve motor function in participants compared to those receiving a placebo.