Tenaya Therapeutics (NASDAQ: TNYA) Unveils Strategic Priorities and Milestones for 2026

Key Developments and Future Directions

SOUTH SAN FRANCISCO, Calif. — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company focused on developing potentially curative therapies for heart diseases, has announced important updates regarding its clinical programs and strategic priorities for 2026. With a successful 2025 behind it, Tenaya aims to build on its achievements and advance its gene therapy initiatives.

2025 Highlights and 2026 Objectives

According to CEO Faraz Ali, “2025 was a momentous year for Tenaya as we demonstrated early evidence of safety and potentially disease-modifying activity for our programs targeting MYBPC3-associated hypertrophic cardiomyopathy (HCM) and PKP2-associated arrhythmogenic cardiomyopathy (ARVC).” These promising results offer hope to patients facing serious heart conditions with limited treatment options.

In 2026, Tenaya anticipates several key milestones:

• Interim data release for Cohort 2 of TN-201 in the MyPEAK-1 trial.
• One-year data from Cohort 1 and early data from Cohort 2 of the RIDGE-1 study.
• Regulatory alignment on pivotal studies for TN-201 and TN-401.

Clinical Development Updates

TN-201: Addressing MYBPC3-Associated HCM

Tenaya expects to report interim data for patients receiving the TN-201 gene therapy for HCM in the first half of 2026. This includes the performance of patients from Cohort 2 who were dosed at 6E13 vg/kg and newer insights from Cohort 1, which had patients receiving 3E13 vg/kg doses.

Key Findings from MyPEAK-1 Trial

In the MyPEAK-1 clinical trial, early results indicated:

• TN-201 was well tolerated with no dose-limiting toxicities.
• Patients successfully tapered off immunosuppressive medication.
• MyBP-C protein levels significantly increased, especially at higher doses.
• Improvement in survival-related parameters was noted amongst patients.

Data has been prominently presented at the 2025 American Heart Association Annual Scientific Sessions.

TN-401: Advancing Treatment for ARVC

The RIDGE-1 Phase 1b/2 clinical trial of TN-401 for PKP2-associated ARVC is also progressing, with a Data Safety Monitoring Board (DSMB) set to evaluate safety data in early 2026. Key findings to date include:

• Well tolerated dose at 3E13 vg/kg with manageable adverse events.
• Robust expression and safety profile demonstrated within eight weeks.

Tenaya plans to release one-year data for Cohort 1 along with initial results from Cohort 2 later in 2026.

Financial Position and Funding

At the end of Q3 2025, Tenaya reported $56.3 million in cash and investments. Following a successful public offering that raised an additional $60 million in December 2025, the company affirms that its financial resources are projected to sustain operations through mid-2027.

Understanding TN-201 and TN-401 Therapies

Both TN-201 and TN-401 are designed to address genetic causes of severe heart diseases. TN-201 utilizes an adeno-associated virus serotype 9 (AAV9) gene therapy to deliver a functional MYBPC3 gene to heart muscle cells, with the goal of reversing HCM. Similarly, TN-401 aims to treat ARVC caused by PKP2 mutations.