secwatch.observer — SEC 8-K summary
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Issuer:     Tenaya Therapeutics, Inc. (TNYA)
CIK:        0001858848
Form:       8-K
Filed at:   2025-11-10T23:59:59+00:00
Accession:  0001193125-25-273230
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tenaya reports Q3 net loss $20.3M; FDA places clinical hold on TN-201 MyPEAK-1 trial
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- Net loss $20.3M ($0.12/share) vs $25.6M ($0.30) in Q3 2024; cash $56.3M, sufficient into H2 2026.
- FDA placed clinical hold on MyPEAK-1 trial of TN-201 (MYBPC3 HCM) after proactive FDA outreach; company expects resolution without impacting timelines.
- New TN-201 data at AHA: Cohort 1 patients at ≥52 weeks showed durable reductions in hypertrophy and biomarkers; dose-dependent MyBP-C protein expression.
- TN-401 (PKP2 ARVC) completed dosing in Cohort 2 (6E13 vg/kg); DSMB positive for expansion; Cohort 1 data expected Q4 2025.
- DSMB recommended dose expansion for TN-201 after positive safety review; no new meaningful safety events since review.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1858848/000119312525273230/0001193125-25-273230-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1858848/000119312525273230/tnya-20251110.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-273230

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