secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2024-10-07T23:59:59+00:00
Accession:  0001104659-24-106461
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Apitegromab meets Phase 3 primary endpoint in SMA; Scholar Rock plans BLA/MAA filing Q1 2025
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- Primary endpoint met: apitegromab improved HFMSE vs placebo (mean diff 1.8 points, p=0.0192) in patients ages 2-12.
- 30.4% of apitegromab patients had >3 point HFMSE improvement vs 12.5% on placebo.
- Benefit observed from first time point at 8 weeks, sustained to 52 weeks.
- Safety profile consistent with prior trials; no SAEs related to apitegromab.
- Company plans to submit BLA to FDA and MAA to EMA in Q1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465924106461/0001104659-24-106461-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465924106461/tm2425688d7_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-106461

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