Roche has announced that it will discontinue development of GYM329 (also known as emugrobart or RO7204239), an investigational anti‑myostatin treatment that had been in clinical trials for both spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy (FSHD).
Roche Ends Clinical Trials of GYM329 for SMA and FSHD
The decision follows detailed reviews of data from the MANOEUVRE Phase II trial in FSHD and the MANATEE Phase II/III programme in SMA.
In a community letter shared with SMA and FSHD groups, Roche explained that although emugrobart was safe for participants, the data did not demonstrate the meaningful clinical benefit needed to continue the studies. As a result, all ongoing trials and related extension studies will now wind down.
This news will understandably be disappointing for families and individuals who had been hopeful about the potential of emugrobart. Research into SMA and FSHD continues across many laboratories and companies worldwide, and organisations remain committed to supporting the development of effective treatments.
Anyone who took part in an emugrobart clinical trial is encouraged to contact their clinical trial site directly. Staff there can provide personalised information about next steps, timelines, and follow‑up care.
Read Roche’s letter to the SMA community and FSHD community.