secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2026-03-03T23:59:59+00:00
Accession:  0001104659-26-022547
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Scholar Rock reports FY2025 net loss $378M; BLA resubmission expected in 2026 after FDA reinspection
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- Net loss $377.9M for 2025 ($3.29 per share) vs $246.3M in 2024; no revenue; cash $367.6M at Dec 31.
- Apitegromab BLA resubmission planned for 2026 after successful FDA reinspection of Catalent Indiana facility.
- Secured up to $550M non-dilutive debt facility with Blue Owl Capital; $100M drawn to retire prior debt.
- EMA decision on apitegromab MAA expected mid-2026; European launch (starting Germany) in H2 2026.
- Phase 2 FORGE trial for FSHD on track for mid-2026; SRK-439 Phase 1 topline data expected H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926022547/0001104659-26-022547-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926022547/srrk-20260303x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-022547

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