secwatch.observer — SEC 8-K summary
======================================

Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2026-05-07T23:59:59+00:00
Accession:  0001104659-26-056655
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Scholar Rock reports Q1 net loss $105.5M; FDA accepts apitegromab BLA with Sep 30 PDUFA
--------------------------------------------------------------------------------

- FDA accepted apitegromab BLA for SMA; PDUFA action date Sep 30, 2026; two fill-finish facilities included.
- Cash of $479.9M as of Mar 31, 2026, includes $100M debt draw and $98M ATM proceeds.
- Q1 2026 net loss $105.5M ($0.83 per share) vs $74.7M ($0.67) in Q1 2025; no revenue.
- R&D expense $51.8M, G&A $50.2M; stock-based compensation $18.2M.
- Pipeline: Phase 2 OPAL trial enrolling; FORGE FSHD trial on track for mid-2026; SRK-439 Phase 1 data H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926056655/0001104659-26-056655-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926056655/srrk-20260507x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-056655

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer