secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2026-08-06T11:10:15+00:00
Accession:  0001193125-26-336715
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Scholar Rock Q2 net loss $109.9M; apitegromab BLA on track for FDA decision by Sept 30, 2026
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- Net loss of $109.9M ($0.84 per share) vs $110.0M ($0.98) in Q2 2025; no revenue recorded.
- Cash, equivalents, and marketable securities of $492.1M as of June 30, 2026, including $62.8M net from ATM.
- Apitegromab BLA for SMA under FDA review with two fill-finish facilities; PDUFA date Sept 30, 2026; ample supply for launch.
- Initiated Phase 2 FORGE trial in FSHD (approx 60 patients, primary endpoint LMV at 12 months).
- Engaging with EMA on apitegromab MAA; FDA inspection classification of Catalent Indiana pending.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/0001193125-26-336715-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-20260806.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-336715

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