FDA places clinical hold on Tenaya's Phase 1b/2a TN-201 trial due to protocol amendment request

Tenaya Therapeutics, Inc.

FDA requests protocol amendment to standardize patient monitoring and immunosuppression management across trial sites.
Clinical hold based on data previously reviewed by DSMB in summer 2025; DSMB found acceptable safety profile for expansion cohorts.
TN-201 generally well tolerated; no new meaningful safety events since DSMB review.
Tenaya working collaboratively with FDA to resolve hold; expects no impact on data milestones or development timelines.
Company intends to resume dosing once protocol changes are implemented at trial sites.

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