FDA lifts clinical hold on TN-201; TN-401 shows positive interim data in ARVC patients

Tenaya Therapeutics, Inc.

FDA removed clinical hold on MyPEAK-1 trial for TN-201 gene therapy; protocol amendments implemented, dosing to resume.
TN-401 well tolerated at 3E13 vg/kg; no dose-limiting toxicities or thrombotic microangiopathy observed.
Robust transduction and PKP2 protein increase in 2 of 3 patients; vector copy numbers 3.4 and 5.0 per genome.
Clinically meaningful arrhythmia reduction: Patient 1 PVCs -46%, Patient 2 PVCs -89% and NSVT from 78 to 0.
One-year Cohort 1 and early Cohort 2 data for TN-201 and TN-401 expected in first half of 2026.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.