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Tenaya Therapeutics Announces New Clinical Data for TN-201 Gene Therapy will be Featured in Late-Breaking Presentation at the American Heart Association Scientific Sessions 2025

Key Takeaway: Tenaya Therapeutics announced that new clinical data for TN-201 gene therapy will be presented at the AHA 2025 Scientific Sessions. The presentations will cover interim safety and efficacy results from the MyPEAK-1 Phase 1b/2a trial for MYBPC3-associated hypertrophic cardiomyopathy, as well as results from a preclinical study on ischemic heart failure. A conference call is scheduled for November 10, 2025, to discuss these findings.
Price reaction · baseline $1.38 (2025-11-04 close) · hit after-hours · 2 other TNYA headline(s) in the window, move may be shared
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POSITIVE FACTORS

  • Interim results show safety and efficacy for TN-201 in HCM patients.
  • Late-breaking presentations at AHA highlight innovative gene therapy approaches.
  • Management will discuss promising data in an upcoming conference call.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+67%
120-day peak, hindsight
Typical move
12%
average across 5 past catalysts
Cash runway
~66 mo
Minimal dilution risk
Lead asset
TN-401
Phase 1 · Arrhythmogenic Right Ventricular Cardiomyopathy

Full Press Release Details

Oral Presentation on Saturday to Highlight Interim Safety and Efficacy Resultsfrom the MyPEAK™-1 Phase 1b/2a Clinical Trial in Adults with MYBPC3-Associated Hypertrophic Cardiomyopathy
Second Late-Breaking Presentation on Sunday to Showcase Results of Cellular Reprogramming Gene Therapy Treatment in Pig Model of Ischemic Heart Failure
Tenaya Management to Host Webcast Conference Call on Monday,November 10, 2025, to Review MyPEAK-1 Data
SOUTH SAN FRANCISCO, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced two late-breaking oral presentations at the American Heart Association (AHA) 2025 Scientific Sessions taking place November 7-10, 2025, in New Orleans, Louisiana.
The AHA presentation of new TN-201 clinical data will include interim safety and efficacy results from dose cohorts 1 and 2 in the MyPEAK-1 Phase 1b/2a clinical trial of TN-201. TN-201 is being developed for the potential treatment of myosin-binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM), a condition caused by insufficient levels of myosin-binding protein C (MyBP-C).
Details of the TN-201 clinical data presentation are as follows:
Abstract Title:TN-201, an InvestigationalMYBPC3Gene Replacement Therapy: Interim Clinical Data from MyPEAK-1, a Phase Ib/2a Study Evaluating Safety and Early Efficacy of TN-201 in Adult Patients withMYBPC3-Associated Hypertrophic CardiomyopathySession Type:Late-Breaking Science: Main Event (Oral Presentation)Session Title:Forgotten No More: The Current Belle of the Ball? Breakthrough Evolutions in Hypertrophic CardiomyopathyPresenting Author:Milind Y Desai, M.D., MBA, director of the Hypertrophic Cardiomyopathy Center at Cleveland Clinic and vice chair of Cleveland Clinic’s Heart, Vascular & Thoracic InstitutePresentation Date & Time:Saturday, November 8, 2025, from 10:25 am – 10:35 am CT
Tenaya will also present results from a preclinical study of its cellular reprogramming treatment in a pig model of ischemic heart failure. The goal of reprogramming gene therapy is to improve heart function following ischemic injury through cardiac cell regeneration. Details for this late-breaking presentation are below:
Abstract Title:First Demonstration of Significant and Durable Improvement of Cardiac Function in Pig Model of Ischemic Heart Failure with Direct Reprogramming Delivered Precisely to Infarct Border via Guided Intramyocardial Injection CatheterSession Type:Late-Breaking Basic Science (Oral Presentation)Session Title:Next-Generation Therapies for Ischemic Heart Repair: From Cells to ImagingPresenting Author:Kathy Ivey, Senior Vice President of Research, Tenaya TherapeuticsPresentation Date & Time:Sunday, November 9, 2025, from 8:00 am – 8:10 am CT
Copies of the presentations at AHA Scientific Sessions 2025 will be available in the “Our Science” and “Investors” sections of the company’s website following each late-breaking session.
Conference Call and WebcastTenaya management will host a conference call on Monday, November 10, 2025, at 8:00 a.m. ET/5:00 a.m. PT to discuss the TN-201 data being presented at the upcoming American Heart Association Scientific Sessions 2025.  Investors and analysts are invited to participate by joining thewebcast. The webcast can be accessed from the investor section of the Tenaya website at www.tenayathera.com.
About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy forMYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy forPKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visitwww.tenayatherapeutics.com.

Tenaya ContactsMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com

InvestorsAnne-Marie FieldsPrecision AQannemarie.fields@precisionaq.com

Frequently Asked Questions

What is TN-201 used for?

TN-201 is a gene therapy being developed for MYBPC3-associated hypertrophic cardiomyopathy.

When will the AHA 2025 presentations take place?

The presentations will occur on November 8 and 9, 2025, at the AHA Scientific Sessions.

How can I access the conference call?

The conference call can be accessed via the investor section of Tenaya's website.

What are the key findings from the MyPEAK-1 trial?

The trial's interim results will highlight safety and efficacy for TN-201 in patients.

Last updated: Nov 4, 2025