Tenaya reports Q3 2026 results, RMAT designation for TN-401, pivotal trial updates due by year end

Tenaya Therapeutics announced its third quarter 2026 financial results and business update on November 4, 2026. In September 2026, the FDA granted Regenerative Medicine Advanced Therapy designation to TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, based on positive interim data from the ongoing RIDGE-1 Phase 1b/2 trial.¹

For TN-401, the company expects to report additional interim data from RIDGE-1 by year end, covering one-year results for Cohort 2 and two-year durability data for Cohort 1.¹ Tenaya management has been meeting with regulators on late-stage pivotal trial planning for TN-401, and plans to share an update on that feedback along with the new data by year end.¹

For TN-201, a gene therapy aimed at MYBPC3-associated hypertrophic cardiomyopathy, the company plans to disclose longer-term MyPEAK-1 trial results by year end, including one-year data for Cohort 2 and two-year durability data for Cohort 1.¹ Tenaya also said it is continuing talks with regulators, with another meeting planned to discuss a potential late-stage pivotal trial design for TN-201, and intends to give an update by year end.¹

On TN-301, an HDAC6 inhibitor being developed for HFpEF and related conditions, the company is doing study-enabling work ahead of Phase 2 trials and intends to start at least one company-sponsored Phase 2 study in the second half of 2027.¹

On finances, Tenaya held $66.8 million in cash and cash equivalents as of September 30, 2026, which it said should fund operations into the fourth quarter of 2027.¹ Net loss for the quarter was $18.9 million, or $0.08 per share, compared with a $20.3 million loss, or $0.12 per share, in the same period of 2025.¹