Today, 19 March 2026, Roche announced that they have made the difficult decision not to advance emugrobart (an investigational anti-myostatin antibody, also known as GYM329) into Phase III development in FSHD.
The decision to stop clinical activities for emugrobart in FSHD follows a rigorous assessment of the data from the MANOEUVRE (NCT05548556) clinical study – a Phase II trial designed to evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of emugrobart, in people aged 18-65 years with FSHD.
Unfortunately, emugrobart did not consistently deliver the hoped for improvements in muscle growth and function in people living with FSHD. This decision was not the result of any safety findings.
While this news may be disappointing, it is expected to offer valuable insights for both the FSHD patient community and future research.
FSHD Europe wishes to thank Roche for their dedication in advancing clinical trials and for the constructive and collaborative partnership throughout this journey.
We would also like to express our sincere appreciation to all the patients who took part in the Roche studies. Your contribution is invaluable.
FSHD Europe remains fully committed to our shared mission of progressing towards an effective treatment for FSHD.
If you have any questions:
- Study participants: Please contact your treating physician. If needed, they can reach out to Roche.
- Community/advocates: Please send your questions to info@fshd-europe.info, FSHD Europe will liaise with the company.
