Aug 05, 2026 —
Tenaya Therapeutics reported second-quarter 2026 financial results and provided updates on its pipeline of therapies targeting the underlying causes of heart disease, including two investigational AAV gene therapies for inherited cardiomyopathies.
The company highlighted positive interim data shared in the second quarter from MyPEAK™-1, evaluating TN-201 in MYBPC3-associated hypertrophic cardiomyopathy, and RIDGE™-1, evaluating TN-401 in PKP2-associated arrhythmogenic right ventricular cardiomyopathy, or ARVC. Tenaya expects additional data releases and updates on regulatory discussions for both programs in the fourth quarter of 2026.
TN-201 is being developed as a gene therapy for patients with hypertrophic cardiomyopathy caused by mutations in MYBPC3. In June 2026, Tenaya reported interim safety and efficacy data from the ongoing MyPEAK-1 Phase 1b/2 trial, including 78 to 104 weeks of follow-up for three patients treated at 3E13 vg/kg and 26 to 52 weeks of follow-up for four patients treated at 6E13 vg/kg.
As of the May 2026 data cutoff, all six evaluable patients achieved reductions in one or more echocardiographic measures of hypertrophy, suggesting cardiac remodeling. All six also showed improvement in one or more measures of symptom burden, including New York Heart Association classification or Kansas City Cardiomyopathy Questionnaire scores.
TN-201 was generally well tolerated across both dose cohorts among the seven patients with reported safety data. No dose-limiting toxicities were observed, and all patients had tapered off immunosuppressive medicines.
Tenaya has completed enrollment needed in MyPEAK-1 to characterize dose response and inform dose selection for late-stage trials. The program has received PRIority MEdicine, or PRIME, designation from the European Medicines Agency and has been accepted into the FDA’s Rare Disease Evidence Principles, or RDEP, process for severe pediatric patients.
TN-401 is being developed as a gene therapy for PKP2-associated ARVC. At the ASGCT Annual Meeting, Tenaya presented interim data from the ongoing RIDGE-1 Phase 1b/2 trial, including three patients treated at 3E13 vg/kg with 32 to 52 weeks of follow-up and three patients treated at 6E13 vg/kg with 20 to 32 weeks of follow-up.
Treatment with TN-401 at either dose resulted in meaningful improvements in electrical stability. Premature ventricular contraction counts decreased in all patients by a mean of 64% from baseline. Two patients who entered the study with high rates of non-sustained ventricular tachycardia experienced substantial reductions as early as Week 20.
TN-401 was generally well tolerated at both doses, with no dose-limiting toxicities observed. All patients had tapered off immunosuppressive medicines as of the April 2026 data cutoff. Tenaya has also completed enrollment needed in RIDGE-1 to characterize dose response and inform late-stage dose selection, and the program received EMA PRIME designation in May 2026.
Tenaya is engaging with regulators on late-stage pivotal trial planning for both TN-201 and TN-401 and plans to provide updates on these discussions in the fourth quarter of 2026.
The company is also advancing TN-301, a small-molecule HDAC6 inhibitor being developed for potential treatment of heart failure with preserved ejection fraction and related cardiac, metabolic, or muscular diseases. Tenaya plans to initiate at least one company-sponsored proof-of-activity Phase 2 trial in the second half of 2027.
As of June 30, 2026, Tenaya reported $78.1 million in cash and cash equivalents, including a $10 million upfront payment from its Alnylam collaboration. The company expects its current cash position to fund planned operations through the third quarter of 2027.
