secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2024-06-03T23:59:59+00:00
Accession:  0001558370-24-008865
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Scholar Rock reports positive SRK-181 Phase 1 data across multiple tumors; ccRCC ORR 23.3%
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- SRK-181 + pembrolizumab showed ORR 23.3% in ccRCC, 27.3% in melanoma, 18.2% in HNSCC, 9.1% in UC; no NSCLC response.
- Safety manageable: no Grade 5 AEs; most common AEs were rash, pruritus, fatigue; one Grade 4 dermatitis exfoliative.
- Biomarker analysis in ccRCC: baseline CD8+ infiltration doubled ORR to 40%; elevated Treg levels raised ORR to 50%.
- Company plans end of Phase 1 meeting with FDA and evaluating partnership opportunities for SRK-181.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000155837024008865/0001558370-24-008865-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000155837024008865/srrk-20240603x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-24-008865

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