Tenaya reports Q3 net loss $20.3M; FDA places clinical hold on TN-201 MyPEAK-1 trial

Tenaya Therapeutics, Inc.

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.

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