BriefIQ Markets · 8-K
FDA Approves ISEMBYLD for SMA, Creating a Major Commercial Milestone with Added Safety Obligations
Key Facts
- On September 14, 2026, Scholar Rock announced that the FDA approved ISEMBYLD (apitegromab-mstn) for adults and children aged 2 years and older with spinal muscular atrophy who are receiving an SMN2-targeted treatment.
- The FDA requested that Scholar Rock submit all serious and non-serious domestic and foreign fracture cases as 15-day alert reports; the company said it intends to comply.
Source
Filing details
- Form
- 8-K
- Symbol
- SRRK
- Company
- Scholar Rock Holding Corp
- CIK
- 0001727196
- Accession number
- 0001104659-26-107721
- SEC filing date
- 2026-09-15
- SEC acceptance time
- 2026-09-15T12:30:50+00:00
- RSS publication time
- 2026-09-15T12:30:50+00:00
- BriefIQ published
- 2026-09-15T12:52:19.467265+00:00
- Reporting period
- 2026-09-15