ISEMBYLD (apitegromab-mstn) is a Scholar Rock Holding Corporation program in Spinal muscular atrophy (SMA), adults and children 2 years and older already on an SMN2-targeted treatment. The FDA approved it on Sep 11, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Spinal muscular atrophy (SMA), adults and children 2 years and older already on an SMN2-targeted treatment. Sponsor: Scholar Rock Holding Corporation (SRRK). Review status: The FDA approved ISEMBYLD (apitegromab-mstn) on September 11, 2026, 19 days before the September 30 goal date Scholar Rock had stated. It is the first muscle-targeted treatment for SMA, approved for adults and children 2 years and older who are already receiving an SMN2-targeted therapy. The BLA had been resubmitted on March 31, 2026 after a September 2025 CRL tied to a third-party fill-finish facility rather than to the drug itself. Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for ISEMBYLD (apitegromab-mstn); 1 FDA decision is on record below.
On Sep 11, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records ISEMBYLD (apitegromab-mstn) is under review or in development for Spinal muscular atrophy (SMA), adults and children 2 years and older already on an SMN2-targeted treatment.
Scholar Rock Holding Corporation (SRRK).
Yes. The FDA approved an application for ISEMBYLD (apitegromab-mstn) on Sep 11, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.