Tenaya Therapeutics announces late-breaking presentations on TN-201 trial results and cellular reprogramming therapy at AHA 2025.
Quiver AI Summary
Tenaya Therapeutics, Inc. announced two late-breaking presentations at the American Heart Association (AHA) 2025 Scientific Sessions, scheduled for November 7-10 in New Orleans. The first presentation will share interim safety and efficacy results from the MyPEAK-1 Phase 1b/2a trial of TN-201, a gene replacement therapy for hypertrophic cardiomyopathy associated with MYBPC3 mutations. This session will occur on Saturday, November 8, 2025. The second presentation, on Sunday, November 9, will highlight preclinical results from a study on cellular reprogramming gene therapy in a pig model of ischemic heart failure. Following the conference, Tenaya will host a webcast on November 10, 2025, to discuss the presented data with investors and analysts. More details will be available on Tenaya's website post-presentation.
Potential Positives
- Two late-breaking oral presentations at the American Heart Association 2025 Scientific Sessions highlight Tenaya Therapeutics' advancements in gene therapy for serious heart conditions.
- The MyPEAK-1 clinical trial results for TN-201 potentially offer significant insights into the safety and efficacy of a new treatment for MYBPC3-associated hypertrophic cardiomyopathy, a major heart disease.
- The upcoming webcast conference call scheduled for November 10, 2025, allows investors to engage directly with Tenaya's management, enhancing transparency and communication.
Potential Negatives
- Interim clinical results highlight the early stage of development for TN-201, which may raise concerns among investors regarding the therapy's long-term efficacy and safety.
- Details on specific outcomes from the interim safety and efficacy results have not been disclosed, potentially leading to uncertainty about the therapy's effectiveness among stakeholders.
- The focus on preclinical animal studies for another treatment (cellular reprogramming) without showing human data could diminish investor confidence in the company's ability to deliver viable therapies.
FAQ
What are the highlights of the MyPEAK-1 clinical trial presentation?
The presentation will showcase interim safety and efficacy results of TN-201 for MYBPC3-associated HCM.
When will Tenaya's presentations at the AHA Scientific Sessions occur?
The MyPEAK-1 presentation is on November 8, and the preclinical study presentation is on November 9, 2025.
How can investors access the conference call regarding the TN-201 data?
Investors can join the conference call on November 10 by accessing it through Tenaya's investor website.
What is the purpose of the cellular reprogramming therapy presented?
The therapy aims to enhance heart function by regenerating cardiac cells after ischemic injury.
Where can I find copies of the presentations from the AHA sessions?
Copies will be available in the “Our Science” and “Investors” sections on Tenaya's website.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$TNYA Insider Trading Activity
$TNYA insiders have traded $TNYA stock on the open market 12 times in the past 6 months. Of those trades, 0 have been purchases and 12 have been sales.
Here’s a breakdown of recent trading of $TNYA stock by insiders over the last 6 months:
- FARAZ ALI (Chief Executive Officer) has made 0 purchases and 4 sales selling 17,722 shares for an estimated $19,621.
- WHITTEMORE TINGLEY (Chief Medical Officer) has made 0 purchases and 4 sales selling 7,990 shares for an estimated $7,631.
- TOMOHIRO HIGA (SVP, Finance) has made 0 purchases and 4 sales selling 4,352 shares for an estimated $4,326.
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$TNYA Hedge Fund Activity
We have seen 40 institutional investors add shares of $TNYA stock to their portfolio, and 66 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CASDIN CAPITAL, LLC removed 6,371,002 shares (-94.6%) from their portfolio in Q2 2025, for an estimated $3,893,956
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$TNYA Analyst Ratings
Wall Street analysts have issued reports on $TNYA in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- HC Wainwright & Co. issued a "Buy" rating on 09/02/2025
- Chardan Capital issued a "Buy" rating on 08/07/2025
To track analyst ratings and price targets for $TNYA, check out Quiver Quantitative's $TNYA forecast page.
$TNYA Price Targets
Multiple analysts have issued price targets for $TNYA recently. We have seen 2 analysts offer price targets for $TNYA in the last 6 months, with a median target of $7.0.
Here are some recent targets:
- Joseph Pantginis from HC Wainwright & Co. set a target price of $5.0 on 09/02/2025
- Geulah Livshits from Chardan Capital set a target price of $9.0 on 08/07/2025
Full Release
Oral Presentation on Saturday to Highlight Interim Safety and Efficacy Results from 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 Investigational
MYBPC3
Gene Replacement Therapy: Interim Clinical Data from MyPEAK-1, a Phase Ib/2a Study Evaluating Safety and Early Efficacy of TN-201 in Adult Patients with
MYBPC3
-Associated Hypertrophic Cardiomyopathy
Session Type:
Late-Breaking Science: Main Event (Oral Presentation)
Session Title:
Forgotten No More: The Current Belle of the Ball? Breakthrough Evolutions in Hypertrophic Cardiomyopathy
Presenting 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 Institute
Presentation 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 Catheter
Session Type:
Late-Breaking Basic Science (Oral Presentation)
Session Title:
Next-Generation Therapies for Ischemic Heart Repair: From Cells to Imaging
Presenting Author:
Kathy Ivey, Senior Vice President of Research, Tenaya Therapeutics
Presentation 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 Webcast
Tenaya 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 the
webcast
. The webcast can be accessed from the investor section of the Tenaya website at www.tenayathera.com.
About Tenaya Therapeutics
Tenaya 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 for
MYBPC3
-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for
PKP2
-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, visit
www.tenayatherapeutics.com
.
Tenaya Contacts
Michelle Corral
VP, Corporate Communications and Investor Relations
[email protected]
Investors
Anne-Marie Fields
Precision AQ
[email protected]
Media
Wendy Ryan
Ten Bridge Communications
[email protected]
