Welcome to our dedicated page for Tenaya Therapeutics news (Ticker: TNYA), a resource for investors and traders seeking the latest updates and insights on Tenaya Therapeutics stock.
Tenaya Therapeutics, Inc. (NASDAQ: TNYA) is a clinical-stage biotechnology company focused on discovering, developing and delivering potentially curative therapies that address the underlying drivers of heart disease. The Tenaya Therapeutics news feed highlights company announcements, clinical data updates and financial disclosures related to its gene therapy and small molecule programs for genetic cardiomyopathies and heart failure.
News about Tenaya frequently centers on TN-201, its AAV9-based gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), and TN-401, its AAV9-based gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Company press releases provide interim safety, biopsy and early efficacy results from the MyPEAK-1 and RIDGE-1 Phase 1b/2 clinical trials, including observations on protein expression, arrhythmia measures and biomarkers.
Investors and followers of TNYA can also find updates on regulatory interactions, such as FDA designations and clinical hold communications, as well as information on Tenaya’s capital-raising activities through public offerings described in SEC filings and related press releases. Additional news items cover participation in scientific and investor conferences, late-breaking presentations at major cardiology and gene therapy meetings, and publications that describe Tenaya’s research platforms and preclinical findings.
This page aggregates these disclosures so readers can review Tenaya Therapeutics’ latest reported milestones, from clinical trial progress for TN-201 and TN-401 to developments in its broader pipeline, including the TN-301 small molecule HDAC6 inhibitor and early-stage preclinical programs. For those tracking TNYA, the news stream offers a consolidated view of how the company reports advancing its mission to address genetic drivers of heart disease.
Tenaya Therapeutics (NASDAQ: TNYA) outlined 2026 priorities and clinical milestones for its two lead gene therapies for inherited cardiomyopathies. The company expects interim and longer-term MyPEAK-1 (TN-201 for MYBPC3 HCM) and RIDGE-1 (TN-401 for PKP2 ARVC) data in H1 and H2 2026, plans to pursue regulatory alignment for pivotal studies during 2026, and reported raising $60 million in Dec 2025 to supplement a $56.3 million Q3 2025 cash balance, collectively expected to fund operations through mid-2027.
Earlier interim data showed tolerability, increased MyBP-C protein, biopsy transduction, and early clinical improvements in small cohorts.
Tenaya Therapeutics (Nasdaq: TNYA) priced an underwritten public offering of 50,000,000 units at $1.20 per unit for gross proceeds of $60.0 million before discounts, commissions and expenses. Each unit consists of one share of common stock and a warrant to purchase one share at an exercise price of $1.50; warrants expire five years from issuance and are immediately exercisable.
The company intends to use net proceeds to fund development of clinical and early-stage candidates, particularly TN-201 and TN-401, and for working capital. Closing is expected on or about December 15, 2025, subject to customary conditions.
Tenaya Therapeutics (Nasdaq: TNYA) announced on December 11, 2025 that it intends to offer and sell units consisting of common stock and warrants to purchase common stock, and may offer pre-funded units (pre-funded warrants plus warrants) to certain investors.
All securities will be sold by Tenaya, the pre-funded warrants (if used) will be immediately exercisable and will not expire, and the offering is subject to market conditions with no assurance as to completion, size, or terms. Leerink Partners and Piper Sandler are joint bookrunning managers. The offering will be conducted under a previously declared effective Form S-3 and a preliminary prospectus supplement will be filed with the SEC.
Tenaya Therapeutics (NASDAQ:TNYA) announced the U.S. Food and Drug Administration has removed the clinical hold on the MyPEAK-1 Phase 1b/2a trial of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy.
The company said all FDA concerns were addressed and protocol amendments are being implemented with sites to standardize patient monitoring and immunosuppressive management before resuming dosing. The prophylactic prednisone and sirolimus regimen remains unchanged; amendments formalize shorter durations and lower cumulative doses between cohorts despite a higher TN-201 dose.
Tenaya highlighted Cohort 1 data at ≥52 weeks and Cohort 2 data at 12- and 26-weeks presented at the American Heart Association Scientific Sessions and published in Cardiovascular Research. The DSMB previously endorsed continued enrollment and no new safety concerns have been reported. The company does not expect the hold to affect data milestones or timelines.
Tenaya Therapeutics (NASDAQ: TNYA) reported interim RIDGE-1 Phase 1b/2 data for TN-401 gene therapy in adults with PKP2-associated ARVC as of an October 2025 data cut-off.
Key findings: 3 patients dosed at 3E13 vg/kg (20–40 weeks follow-up); TN-401 was well tolerated with no dose-limiting toxicities; robust cardiac transduction and high mRNA expression (1.4x104–2.9x105 copies/µg RNA) detected by Week 8; mean PKP2 protein rose ~10% in Patients 1–2 at Week 8; clinically meaningful PVC reductions of 46% and 89% in Patients 1 and 2, respectively.
Tenaya Therapeutics (NASDAQ: TNYA) reported Q3 2025 results and clinical updates on Nov 10, 2025. Cash, cash equivalents and marketable securities were $56.3M, which management says supports operations into the second half of 2026. Q3 operating trends showed lower expenses: R&D $15.4M (Q3 2024: $20.4M) and G&A $5.6M (Q3 2024: $6.4M). Net loss narrowed to $20.3M or $0.12 per share versus $25.6M ($0.30) year-ago.
Clinically, Tenaya presented MyPEAK-1 (TN-201) ≥52-week Cohort 1 data showing durable, dose-dependent MyBP-C protein increases and deeper reductions in hypertrophy measures; MyPEAK-1 is on a protocol-driven clinical hold while an amendment and standardized immunosuppression measures are implemented. RIDGE-1 (TN-401) dosing completed in Cohort 2 (three patients at 6E13 vg/kg); Cohort 1 data expected before year-end 2025.
Tenaya Therapeutics (NASDAQ: TNYA) presented interim MyPEAK-1 Phase 1b/2a data for TN-201 on Nov 8, 2025. Single-dose TN-201 at 3E13 vg/kg and 6E13 vg/kg was generally well tolerated with no dose-limiting toxicities and manageable immunosuppression.
Key efficacy signals: average MyBP-C protein +4% in Cohort 1 at Week 52, early +14% MyBP-C in a Cohort 2 patient at Week 12, LVPWT reductions 21%–39%, LVMI reductions 12%–22% in two Cohort 1 patients, and Cardiac Troponin I declines 48%–74%. Two treatment-related serious AEs were reported; reversible liver enzyme elevations were the most common AE.
Tenaya Therapeutics (NASDAQ: TNYA) announced two late-breaking oral presentations at the American Heart Association Scientific Sessions 2025 on November 8–9, 2025 highlighting new clinical and preclinical data.
Key items: interim safety and efficacy results from dose cohorts 1 and 2 of the MyPEAK-1 Phase 1b/2a study of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy will be presented on Nov 8, 2025, 10:25–10:35 am CT by Milind Y Desai, M.D., MBA. A separate late-breaking oral presentation of a cellular reprogramming gene therapy showing significant and durable improvement in cardiac function in a pig ischemic heart failure model will be presented on Nov 9, 2025, 8:00–8:10 am CT by Kathy Ivey.
Tenaya will host a webcast and conference call on Nov 10, 2025 at 8:00 am ET to discuss MyPEAK-1 data; presentations will be posted on the company website after each session.
Tenaya Therapeutics (NASDAQ: TNYA) announced that CEO Faraz Ali will participate in a fireside chat at the H.C. Wainwright Genetic Medicines Virtual Conference on October 14, 2025. Company management will hold virtual 1x1 meetings on October 15, 2025. The fireside chat will be webcast and accessible from the Investors section of Tenaya's website, with an archived replay available for approximately 30 days after the conference.
Tenaya Therapeutics (NASDAQ: TNYA) announced CEO Faraz Ali will participate in investor and industry conferences in October 2025. Key events: Cell & Gene Meeting on the Mesa on October 6 with a panel at 8:00–9:00 AM MT and a company presentation at 12:00–12:15 PM MT; and the Chardan Annual Genetic Medicines Conference on October 21 with a panel 12:00–12:40 PM ET titled "In Vivo Gene Therapies for Genetic Cardiac Diseases."
The Chardan panel will be webcast live and an archived replay will be available on Tenaya's investor website for ~30 days.
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