---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-037350"
form_type: "8-K"
ticker: "SRRK"
cik: "0001727196"
company_name: "Scholar Rock Holding Corp"
filed_at: "2026-03-31T23:59:59+00:00"
generated_at: "2026-05-15T08:11:51.324542+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Scholar Rock resubmits BLA for apitegromab SMA; PDUFA goal late Sept 2026

## Summary
- Resubmission follows Sep 2025 CRL related to Catalent Indiana facility; no other approvability concerns cited.
- FDA acceptance expected within 30 days; review up to 6 months; PDUFA decision target late September 2026.
- Includes second U.S. fill-finish facility after positive Type C meeting on March 3, 2026.
- European MAA for apitegromab progressing; decision anticipated mid-2026.
- CEO David L. Hallal expects U.S. and European approvals and launches this year.

## SEC filing metadata
- accession: 0001104659-26-037350
- form_type: 8-K
- ticker: SRRK
- cik: 0001727196
- company_name: Scholar Rock Holding Corp
- filed_at: 2026-03-31T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/0001104659-26-037350-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/tm2610664d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-037350
- JSON: https://secwatch.observer/filing/0001104659-26-037350.json
- Plain text: https://secwatch.observer/filing/0001104659-26-037350.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.