• EN

    • -+ 0.00%
    -+ 0.00%
    -+ 0.00%

    Tenaya Therapeutics (TNYA) Is Down 39.7% After FDA Lifts TN-201 Hold and Trial Updates - What's Changed

    Simply Wall St·12/13/2025 15:35:58
    Listen to the news
    • Earlier this month, Tenaya Therapeutics reported that the FDA lifted the clinical hold on its MyPEAK-1 Phase 1b/2a trial of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy and released encouraging interim Phase 1b/2 data for TN-401 in arrhythmogenic right ventricular cardiomyopathy, while also completing a US$60,000,000 composite units offering.
    • Together, the resumed TN-201 trial and early TN-401 signals highlight Tenaya’s push to use AAV9-based gene therapies to address inherited cardiac conditions with no approved genetic treatments.
    • We’ll now examine how the FDA’s removal of the TN-201 clinical hold influences Tenaya’s investment narrative and perceived long-term opportunity.

    These 11 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.

    What Is Tenaya Therapeutics' Investment Narrative?

    For Tenaya, the big picture you need to believe in is that AAV9-based gene therapies can move from early cardiac proof-of-concept to meaningful commercial products before the company’s cash and shareholder patience run thin. The FDA lifting the TN-201 MyPEAK-1 hold directly improves the near-term setup by restoring a key catalyst that had been in doubt, while the early TN-401 RIDGE-1 data adds another potential value driver on the same cardiovascular gene therapy platform. Together with the fresh US$60,000,000 composite units raise, these updates ease immediate financing pressure but also reinforce dilution as an ongoing risk, especially with no revenue and a history of rising losses. In the short term, investor focus now swings back to clinical readouts and cash runway rather than regulatory overhang.

    However, one risk now stands out that many Tenaya shareholders may be underestimating. Our valuation report unveils the possibility Tenaya Therapeutics' shares may be trading at a premium.

    Exploring Other Perspectives

    TNYA 1-Year Stock Price Chart
    TNYA 1-Year Stock Price Chart
    Fourteen fair value estimates from the Simply Wall St Community span roughly US$1 to just under US$10 per share, underlining how far apart opinions sit. Against that backdrop, the recent trial restart, early TN-401 data and repeated equity raises highlight why your view on clinical execution and dilution risk could heavily shape how you see Tenaya’s long term potential.

    Explore 14 other fair value estimates on Tenaya Therapeutics - why the stock might be worth just $0.957!

    Build Your Own Tenaya Therapeutics Narrative

    Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.

    Searching For A Fresh Perspective?

    Don't miss your shot at the next 10-bagger. Our latest stock picks just dropped:

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.