Press Releases June 2, 2026 04:30 PM

Tenaya Therapeutics to Announce New Interim Data from MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM on Wednesday, June 3, 2026

Tenaya Therapeutics to announce new interim clinical trial data for TN-201 gene therapy targeting MYBPC3-associated hypertrophic cardiomyopathy.

By Nina Shah TNYA

Tenaya Therapeutics will present new interim data from cohorts 1 and 2 of the Phase 1b/2 MyPEAK-1 trial evaluating TN-201, a gene therapy aimed at treating adults with MYBPC3-associated hypertrophic cardiomyopathy (HCM). The company highlights TN-201’s potential to address the genetic root cause of this severe heart condition through a single intravenous infusion, and the therapy has received multiple regulatory designations including Fast Track and Orphan Drug status.

Tenaya Therapeutics to Announce New Interim Data from MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM on Wednesday, June 3, 2026
TNYA

Key Points

  • TN-201 is a gene therapy designed to deliver a functional MYBPC3 gene to heart cells, aiming to halt or reverse hypertrophic cardiomyopathy caused by MYBPC3 mutations.
  • The ongoing MyPEAK-1 Phase 1b/2 trial is generating interim data that will be shared publicly via webcast, signaling progress in clinical development.
  • MYBPC3-associated HCM affects a significant patient population with severe symptoms and currently lacks approved treatments targeting its genetic basis.
  • Sectors impacted include biotechnology, healthcare (cardiovascular therapeutics), and gene therapy markets.

SOUTH SAN FRANCISCO, Calif., June 02, 2026 (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, today announced that it will report new interim data from Cohort 1 and Cohort 2 of the ongoing MyPEAK™-1 Phase 1b/2 trial of TN-201 gene therapy for adults with MYBPC3-associated hypertrophic cardiomyopathy (HCM) on Wednesday, June 3, 2026.

Webcast Details:

Tenaya Therapeutics will host a live webcast to review the new data from MyPEAK™-1 on Wednesday, June 3, 2026 at 8:00 a.m. ET. To access the live event, participants may register here. The live webcast will be available under “Events & Presentations” in the Investors section of Tenaya’s website.

An archived replay of the webcast will be available on the Tenaya website for approximately 30 days following the live event.

About MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
Variants in the Myosin Binding Protein C3 (MYBPC3) gene are the most common genetic cause of hypertrophic cardiomyopathy (HCM), accounting for approximately 20% of the overall HCM population, or 120,000 patients, in the United States alone. MYBPC3-associated HCM is a severe and progressive condition affecting adults, teens, children and infants. Mutations of the MYBPC3 gene result in insufficient expression of a protein, called MyBP-C, needed to regulate heart contraction. The heart becomes hypercontractile and the left ventricle thickens, resulting in symptoms such as chest pain, shortness of breath, palpitations and fainting. Patients whose disease is caused by MYBPC3 mutations are more likely than those with non-genetic forms of HCM to experience earlier disease onset and have high rates of serious outcomes, including heart failure symptoms, arrhythmias, stroke and sudden cardiac arrest or death. There are currently no approved therapeutics that address the underlying genetic cause of HCM.

About TN-201
TN-201 is an adeno-associated virus serotype 9 (AAV9)-based gene therapy designed to address the underlying cause of MYBPC3-associated hypertrophic cardiomyopathy (HCM) by delivering a working MYBPC3 gene to heart muscle cells via a single intravenous infusion and thereby increasing insufficient MyBP-C protein levels with the aim of halting or even reversing disease after a single dose. The U.S. Food and Drug Administration has granted TN-201 Fast Track, Orphan Drug and Rare Pediatric Drug Designations. TN-201 has also received orphan medicinal product from the European Commission.

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); TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC); and TN-301, a highly specific small molecule HDAC6 inhibitor with broad potential clinical utility in cardiac, metabolic and muscular conditions, including heart failure with preserved ejection fraction (HFpEF) and Duchenne muscular dystrophy (DMD). Tenaya has employed a suite of integrated internal capabilities including modality agnostic target discovery and validation, to generate a portfolio of novel medicines based on genetic insights, 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]


Risks

  • The clinical trial is ongoing and interim data may be inconclusive or reveal safety/efficacy concerns.
  • Regulatory approvals remain uncertain despite multiple designations; failure to obtain approval could delay or halt commercialization.
  • The gene therapy approach is novel and may face challenges regarding manufacturing, delivery, long-term effects, and reimbursement.

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