TNYA

One-Year Cohort 1 Data and Initial Cohort 2 Data from RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC to be Presented at ASGCT 2026 New Data from Both Cohorts of the MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM Expected in the Second Quarter 2026 Preclinical Data at MDA 2026 Highlighted TN-301’s Activity in Duchenne Muscular Dystrophy Disease Models; Distinct Mechanism of HDAC6 Inhibition Supportive of TN-301’s Potential in Multiple Indications Entered Research Collaboration with Alnylam to Identify and Validate Genetic Targets for Cardiovascular Conditions SOUTH SAN FRANCISCO, Calif., May 06, 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 financial results for the first quarter ended March 31, 2026, and provided a corporate update. “We are entering a catalyst-rich period for Tenaya, with multiple clinical milestones expected across our lead gene therapy programs throughout 2026. Building on the encouraging initial readouts we reported in 2025, we believe the additional data expected this year from both TN-201 and TN-401 may support alignment on registrational pathways for these novel gene therapies,” said Faraz Ali, Chief Executive Officer of Tenaya. Mr. Ali continued, “While our focus remains on the advancement of TN-201 and TN-401 for patients suffering from these genetic cardiomyopathies, we also announced meaningful steps in the direction of our next horizon of opportunities to address unmet patient needs and to create value for stockholders. We presented new preclinical data for TN-301, our clinical-stage small molecule candidate, in Duchenne muscular dystrophy adding to the body of compelling preclinical evidence for the broad clinical utility of this molecule in multiple prevalent and rare cardiac and cardiac-adjacent indications. Advancing TN-301 toward a trial in patients reflects our commitment to building a diversified portfolio grounded in mechanistic insight and translational rigor. The recently announced collaboration with Alnylam also reinforces the strength of Tenaya's innovation engine and expands the reach and impact of our modality-agnostic research capabilities.” Business and Program Updates...

Reported Promising Data for TN-201 and TN-401 Gene Therapies in Fourth Quarter of 2025; Additional Data Readouts and Pursuit of Regulatory Alignment for Each Program Planned in 2026 New Research Supports TN-301’s Potential in Multiple Indications; Presented Preclinical Data for TN-301 in Duchenne Muscular Dystrophy Model Entered into Multi-Target Research Collaboration with Alnylam Pharmaceuticals December Financing with Net Proceeds of $55.8M and Anticipated Upfront Payment Extend Cash Runway into Second Half of 2027 SOUTH SAN FRANCISCO, Calif., March 11, 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 financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update. “As we enter 2026, we are energized by the momentum and clinical advances achieved over the past year,” said Faraz Ali, Chief Executive Officer of Tenaya. “The encouraging data presented in 2025 from both of our lead gene therapy programs underscore the transformative potential of our science. In the first half of 2026, we expect to share additional updates, including longer-term follow-up data from the MyPEAK™-1 clinical trial of TN-201 for MYBPC3-associated HCM, as well as one-year Cohort 1 data and early Cohort 2 data from the RIDGE™-1 clinical trial of TN-401 for PKP2-associated ARVC. Over the course of the year, we also plan to pursue regulatory agency alignment on pivotal trial plans for both programs, a critical step toward accelerating the delivery of safe and effective gene therapies to patients with serious cardiac conditions.” Mr. Ali continued, “We are also excited to take modest but important steps to move TN-301 -- our clinical-stage, highly selective, small molecule HDAC6 inhibitor -- forward towards patients. New preclinical data in relevant DMD models that we presented at the recent MDA meeting adds to a growing body of external evidence supporting the potentially broad clinical utility of TN-301 in a range of cardiac and cardiac-adjacent indications with high unmet patient need and large market potential. The recently announced Alnylam collaboration further validates our platform capabilities that originally led to the discovery...

Presentation of MyPEAK-1 Data and the American Heart Association Scientific Sessions Showed Consistent, Deeper, and Durable Improvement in Measures of Hypertrophy for Cohort 1 Patients Initial TN-201 Cohort 2 Data Demonstrated Early Dose Responsive Increases in TN-201 Transduction and MyBP-C Protein Expression Completed Dosing in Cohort 2 of RIDGE™-1 Trial of TN-401 for PKP2-associated ARVC; Cohort 1 Data On Track for Fourth Quarter Company Presentation Tenaya Management to Review New MyPEAK-1 Data on Webcast Call for Analysts and Investors Today at 8:00 a.m. EST SOUTH SAN FRANCISCO, Calif., Nov. 10, 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, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. “Throughout the third quarter, we made important steps advancing our two lead gene therapy programs to provide transformative treatments to patients with serious genetic cardiomyopathies,” said Faraz Ali, Chief Executive Officer of Tenaya. “TN-201 and TN-401 each received positive recommendations from their respective Data Safety Monitoring Boards to advance into the dose expansion cohorts reflecting confidence in each product’s emerging safety profile. We were particularly pleased with the positive safety and promising clinical data presented on TN-201 as a potential treatment for MYBPC3-associated HCM at the recent AHA Scientific Sessions. We also look forward to sharing meaningful safety and interim biopsy and efficacy data from the RIDGE-1 trial of TN-401 for patients with PKP2-associated ARVC in the coming weeks.” Business and Program Updates TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) New data from the Phase 1b/2a MyPEAK-1 clinical trial of TN-201 were presented by Milind Desai, M.D., M.B.A., director of the Hypertrophic Cardiomyopathy Center at Cleveland Clinic and vice chair, Heart Vascular Thoracic Institute, Cleveland Clinic as a late-breaking oral presentation at the American Heart Association (AHA) Scientific Sessions on Saturday, November 8, 2025. The AHA presentation included updated data from Cohort 1 patients at ≥52-weeks of follow-up, as well as safety and available...

Enrollment Complete in Cohorts 1 and 2 of MyPEAK™-1 Phase 1b/2 Trial of TN-201 for MYBPC3-associated HCM; Positive DSMB Safety Review Enables Enrollment of Expansion Cohorts Cohort 1 of RIDGE™-1 Phase 1b Trial of TN-401 Enrolled and First PKP2-associated ARVC Patient Dosed in Cohort 2 Following DSMB Recommendation to Dose Escalate and Expand Data Readouts from Both TN-201 and TN-401 Clinical Programs Planned for the Fourth Quarter of 2025 Cash Runway into Second Half of 2026 SOUTH SAN FRANCISCO, Calif., Aug. 06, 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, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. “During the first half of 2025, we achieved target enrollment in our ongoing gene therapy clinical trials of TN-201 for MYBPC3-associated HCM and of TN-401 for PKP2-associated ARVC. The subsequent positive recommendations for dose escalation and/or expansion from each trial’s independent Data Safety Monitoring Board following a review of all available safety data for TN-201 and TN-401 are critical milestones in our mission to address two of the most common and deadly genetic cardiomyopathies,” said Faraz Ali, Chief Executive Officer of Tenaya. “We look forward to sharing meaningful new data readouts for both TN-201 and TN-401 in the fourth quarter of 2025 that will bring us closer to delivering potentially transformative therapies to patients.” Business and Program Updates TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In May, Tenaya completed enrollment and dosing of three patients at the 6E13 vg/kg dose level (Cohort 2) in the MyPEAK™-1 Phase 1b/2 clinical trial of TN-201 for MYBPC3-associated HCM. Following a review of all available safety data, the independent Data Safety Monitoring Board (DSMB) for the MyPEAK-1 trial determined that TN-201 had an acceptable safety profile to enroll dose expansion cohorts at either the 3E13 vg/kg or 6E13 vg/kg dose level. Tenaya currently anticipates enrolling patients in the 6E13 vg/kg dose expansion cohort. MyPEAK-1 is a multi-center, open-label, dose-escalation trial designed to assess safety, tolerability and clinical efficacy of a one-...

Interim Data from Low Dose Cohort in MyPEAKTM-1 Clinical Trial of TN-201 Showed Encouraging Safety Profile, Transduction and Expression, Plus Improvements in Hypertrophy and NYHA Classification RIDGE Natural History and Seroprevalence Study Highlights Significant Disease Burden and Unmet Need Among Adults with PKP2-associated ARVC Data Readouts for TN-201 and TN-401 Clinical Programs On Track for the Second Half of 2025 Cash Runway Extended into Second Half of 2026 SOUTH SAN FRANCISCO, Calif., May 07, 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, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. “2025 is off to a strong start for Tenaya as we delivered positive data from our MyPEAK-1 clinical trial evaluating TN-201 for the potential treatment of MYBPC3-associated HCM, shared new findings from the RIDGE natural history study of adults with PKP2-associated ARVC, and extended our cash runway into the second half of 2026,” said Faraz Ali, Chief Executive Officer of Tenaya. “We are pleased to report that patient enrollment is on track for both the MyPEAK-1 study for TN-201 and the RIDGE-1 study for TN-401 as we drive both programs toward meaningful clinical readouts in the second half of this year. We have also taken important steps to focus our financial resources on clinical execution to help ensure we can take TN-201 and TN-401 through to important clinical milestones in 2026.” Program and Business Updates TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In March 2025, Tenaya shared new interim data from the first cohort enrolled in the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 in a Late-Breaker presentation at the 2025 American College of Cardiology Scientific Sessions. New data from the first three patients showed that TN-201 was well tolerated at a dose of 3E13 vg/kg. Biopsy results from all three patients demonstrated robust DNA transduction and RNA expression similar to or greater than ranges observed in other AAV cardiac gene therapy trials. TN-201 RNA and myosin binding protein C (MyBP-C) protein levels increased over time in Patients 1 and 2 for whom serial biopsies were...