Tenaya Therapeutics, Inc. (TNYA) announced new interim data from its ongoing MyPEAK-1 Phase 1b/2 trial evaluating TN-201, an investigational gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM). The results were presented today, showing consistent signs of cardiac remodeling and symptom improvement across all evaluable patients.
About the Condition
MYBPC3-associated HCM is a genetic form of hypertrophic cardiomyopathy caused by insufficient levels of myosin-binding protein C (MyBP-C), leading to thickening of the heart muscle and impaired function. Patients often experience chest pain, shortness of breath, and fatigue, with limited treatment options that address the underlying genetic cause.
About the MyPEAK-1 Trial
The MyPEAK-1 study is designed to assess the safety and efficacy of a single infusion of TN-201 at two dose levels. As of the May 2026 data cutoff, six patients evaluable for efficacy endpoints showed improvements in multiple clinical parameters, including echocardiographic measures of hypertrophy and symptom burden. Three patients, including two forms of the higher-dose cohort, demonstrated improved exercise capacity.
Tenaya reported that benefits among Cohort 1 patients were sustained for up to two years, while Cohort 2 patients showed greater symptom relief and improved cardiac function at earlier timepoints. These findings suggest durable and dose-responsive effects of TN-201.
Expert Commentary
Whit Tingley, CMO, noted that reductions in left ventricular mass indicate cardiac remodelling over time, a key marker of disease improvement. He added that early signals at the higher dose point to more substantial changes occurring sooner, reinforcing confidence in TN-201's potential benefit for patients with severe disease.
Regulatory and Next Steps
TN-201 has been granted PRIME designation by the European Medicines Agency and accepted into the FDA's Rare Disease Evidence Principles process for its pediatric indication. Tenaya plans to continue follow-up and expand enrolment to further characterization long-term outcomes.
TNYA has traded between $0.48 and $2.35 over the past year. The stock closed Tuesday's trading at $0.79, down 9.20%. In pre-market trading the stock is at $0.87, up 10.75%.
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