SOUTH SAN FRANCISCO, Calif. — January 9, 2026 — Leads & Copy — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company focused on discovering and developing curative therapies for heart disease, has provided an update on its clinical development programs and strategic priorities for 2026.
The company aims to build on positive interim TN-201 results from 2025 in the first half of 2026 with longer-term follow-up data for cohorts 1 and 2 from the MyPEAK™-1 trial of adults with MYBPC3-associated HCM. Tenaya also expects to report one-year Cohort 1 data and early Cohort 2 data from the RIDGE™-1 study of TN-401 for PKP2-associated ARVC in the first half of 2026 and plans to pursue alignment on regulatory pathways for lead gene therapy programs in 2026.
Tenaya raised $60 million in 4Q25 to support operations through mid-2027.
According to Faraz Ali, Chief Executive Officer of Tenaya, 2025 was a momentous year, with early evidence of safety and potential disease-modifying activity demonstrated for gene therapy programs targeting MYBPC3-associated hypertrophic cardiomyopathy and PKP2-associated arrhythmogenic cardiomyopathy.
Ali noted that these results offer hope for patients with inherited heart conditions. The additional capital raised will advance both programs through key clinical milestones in 2026, including more mature data readouts. Tenaya remains focused on delivering potentially curative therapies for individuals with serious genetic heart diseases.
In the first half of 2026, Tenaya expects to share interim data for Cohort 2 patients dosed with 6E13 vg/kg of TN-201, and updates from Cohort 1 patients who received 3E13 vg/kg doses of TN-201 in the MyPEAK-1 Phase 1b/2 clinical trial.
One-year Cohort 2 data and two-year Cohort 1 data from MyPEAK-1 are anticipated in the second half of 2026. Tenaya plans to pursue regulatory alignment on TN-201 pivotal studies during 2026, with an update in the second half of the year.
In November 2025, Tenaya presented data from the MyPEAK-1 trial, including safety, biopsy, and indicators of efficacy results for three patients in Cohort 1 with follow-up ranging from Week 52-78, and initial safety data and biopsy and efficacy results for Cohort 2 patients as of the July 2025 data cut off. TN-201 was generally well tolerated at both dose levels. No dose-limiting toxicities were observed, and all patients successfully tapered off immunosuppressive medicine.
MyBP-C protein levels increased over time, with a substantial increase at the higher dose in Cohort 2. Multiple parameters associated with risk of complications and/or survival improved among a majority of patients with greater than 26 weeks of follow-up.
The data were presented at the 2025 American Heart Association Annual Scientific Sessions and published in Cardiovascular Research.
Seven patients have been enrolled in the MyPEAK-1 trial. Following protocol amendments in alignment with FDA input, Tenaya expects to resume enrollment in the 6E13 vg/kg dose expansion cohort to generate additional data in 2026.
In the first quarter of 2026, the DSMB for the RIDGE-1 Phase 1b/2 clinical trial of TN-401 is expected to convene. The DSMB will review safety data for the three patients dosed at 3E13 vg/kg (Cohort 1) and three patients dosed at 6E13 vg/kg (Cohort 2,) dose levels. Following the DSMB review, Tenaya plans to continue to enroll patients in RIDGE-1 at one or both dose levels.
Tenaya expects to present one-year data for Cohort 1 and initial Cohort 2 data in the first half of 2026. Additional Cohort 2 data is anticipated in the second half of 2026. The company plans to pursue regulatory alignment on TN-401 pivotal studies in the second half of 2026 and to share an update by year-end, as available.
In December 2025, Tenaya presented initial Cohort 1 data in the RIDGE-1 clinical trial. The data included safety, biopsy and arrhythmia results from Cohort 1 as of the October 2025 data cut off, with follow-up ranging from 20-40 weeks post-dose. TN-401 was well tolerated at the 3E13 vg/kg dose, and no dose-limiting toxicities were observed. Adverse events were generally mild, asymptomatic and manageable and deemed unrelated to TN-401 treatment.
Biopsies demonstrated robust transduction and expression in all patients within first eight weeks. Clinically meaningful improvements in electrical instability were observed in the first two patients with greater than six months follow-up after TN-401 dosing. Enrollment and dosing of Cohort 2 is complete with no new serious AEs related to TN-401 reported to date.
In July 2025, the RIDGE-1 trial DSMB reviewed all available data and endorsed dose escalation to the 6E13 vg/kg level and expanding enrollment of Cohort 1, per protocol.
Tenaya ended the third quarter of 2025 with $56.3 million in cash, cash equivalents and investments in marketable securities. With the additional proceeds of $60 million from the December 2025 public offering, the company expects that such resources will be sufficient to fund planned operations through mid-2027.
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com
Source: Tenaya Therapeutics
