Scholar Rock Inc
1 products tracked · names used in filings: Scholar Rock Inc, Scholar Rock Holding Corp
Upcoming milestones
No upcoming milestones listed.
Recent milestones
FDA approves Isembyld (apitegromab-mstn), a new medicine
Scholar Rock Inc; BLA761463; New biologic, Priority review; injectable · source
Scholar Rock Holding Corp: PDUFA target action date
Scholar Rock Holding Corp (SRRK); "…eded to support its business activities; its ability to receive priority or expedited regulatory review or to obtain regulatory approval of apitegromab; its ability to expand globally and the anticipated commercial launch in the United States of apitegromab in 2026; as well as those risks more fully discussed in…"; filed 2026-05-07 · source
apitegromab: PDUFA target action date (spinal muscular atrophy (SMA))
Scholar Rock Holding Corp (SRRK); apitegromab; BLA; status: set; "…FDA accepted the apitegromab BLA under priority review with a PDUFA target action of September 22, 2025; finalizing U.S."; filed 2025-08-06 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Isembyld apitegromab-mstn | Approved | 2026-09-11 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.