secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2023-06-30T23:59:59+00:00
Accession:  0001157523-23-001060
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Scholar Rock reports 36-month TOPAZ data: sustained motor function and safety; Phase 3 on track
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- Mean HFMSE change from baseline at 36 months: +4.0 points (95% CI 1.0-6.9, N=28).
- Mean RULM change from baseline at 36 months: +2.4 points (95% CI 1.1-3.7, N=27).
- PEDI-CAT daily activity +2.2; PROMIS-Fatigue -4.6 at 36 months, consistent with motor gains.
- Safety: 198 patient-years exposure; >90% remained on study; no new safety signals or ADA.
- Phase 3 SAPPHIRE enrollment expected to complete Q3 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000115752323001060/0001157523-23-001060-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000115752323001060/a53438186.htm
  HTML page:      https://secwatch.observer/filing/0001157523-23-001060

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