Apitegromab 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. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Apitegromab is marketed as ISEMBYLD (apitegromab-mstn); the events below include those tracked under the brand name. FDA approval tracked on pdufa.bio: spinal muscular atrophy (SMA), adults and children 2 years and older already on an SMN2-targeted treatment (approved Sep 11, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Scholar Rock Holding Corporation (SRRK). Approval record: 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Redmile Group | 4,311,092 | $237.1 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Apitegromab; 2 FDA decisions are 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 Apitegromab is FDA-approved for spinal muscular atrophy (SMA), adults and children 2 years and older already on an SMN2-targeted treatment (approved Sep 11, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Scholar Rock Holding Corporation (SRRK).
Yes. The FDA approved an application for Apitegromab 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.