Tenaya Therapeutics, Inc. Stock Price, News & Analysis

Tenaya Therapeutics (NASDAQ: TNYA) presented interim data from MyClimb™, the largest natural history study of pediatric patients with MYBPC3-associated hypertrophic cardiomyopathy (HCM), at the European Society of Cardiology Congress 2025. The study analyzed 213 participants from 27 centers across multiple countries.

Key findings revealed that 93% of participants had nonobstructive HCM, which currently lacks approved treatments. The study identified three genetic inheritance patterns with distinct risk profiles: Homozygous patients typically died or needed heart transplant before age one, Compound Heterozygous patients showed severe symptoms with 27% requiring transplant or dying, and Heterozygous patients had later onset but still significant complications.

Importantly, Left Ventricular Mass Index (LVMI) emerged as a significant predictor of risk, with every 10-unit increase associated with a 10% higher hazard of serious events, potentially serving as a surrogate marker for future gene therapy studies.

Tenaya Therapeutics (NASDAQ: TNYA), a clinical-stage biotech company focused on developing curative therapies for heart disease, has announced its participation in the upcoming Canaccord Genuity 45th Annual Growth Conference. The company's CEO, Faraz Ali, will engage in a fireside chat on Tuesday, August 12, 2025 at 11:30 am ET.

Investors can access the live webcast through Tenaya's website's Investor section, with a replay available for approximately 30 days after the event.

Tenaya Therapeutics (NASDAQ: TNYA) reported significant progress in its Q2 2025 clinical trials for genetic cardiomyopathies. The company completed enrollment in Cohorts 1 and 2 of the MyPEAK-1 trial for TN-201 (MYBPC3-associated HCM) and received positive DSMB safety reviews enabling expansion cohorts. For TN-401 (PKP2-associated ARVC), Cohort 1 enrollment is complete and the first patient in Cohort 2 has been dosed following DSMB recommendation.

Key financial metrics include $71.7 million in cash and equivalents, with runway extending into H2 2026. Q2 2025 showed a net loss of $23.3 million ($0.14 per share), improved from $29.4 million loss in Q2 2024. The company expects important data readouts for both TN-201 and TN-401 in Q4 2025.

Tenaya Therapeutics (NASDAQ: TNYA) announced positive safety reviews from independent Data Safety Monitoring Boards (DSMBs) for its two cardiovascular gene therapy clinical trials. The MyPEAK-1 trial for TN-201 treating MYBPC3-associated hypertrophic cardiomyopathy has completed enrollment in both dose cohorts, with follow-up data expected in Q4 2025. Early results showed robust RNA expression and improved heart failure symptoms in Cohort 1 patients.

The RIDGE-1 trial for TN-401, targeting PKP2-associated arrhythmogenic right ventricular cardiomyopathy, has dosed its first patient in Cohort 2 at 6E13 vg/kg. Initial Cohort 1 data is expected in Q4 2025. Both trials received endorsements to proceed with expansion cohorts, highlighting favorable safety profiles.

Tenaya Therapeutics (NASDAQ: TNYA), a clinical-stage biotech company focused on heart disease therapies, has granted stock options to three new non-executive employees. The inducement grants total 461,000 shares of common stock with an exercise price of $0.4373 per share, matching Tenaya's closing price on May 15, 2025. The options have a 10-year term and follow a four-year vesting schedule: 25% vests after one year, followed by monthly vesting of 1/48th of shares. These grants were made under the company's 2024 Inducement Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4).

Tenaya Therapeutics (NASDAQ: TNYA) will present five abstracts at the ASGCT 2025 Annual Meeting showcasing advancements in genetic medicine for heart disease. Key highlights include: 1. Enhanced Capsid Engineering: Development of novel AAV capsids outperforming AAV9 in cardiomyocyte targeting and cardiac gene therapy delivery. 2. Prime Editing Progress: Successfully demonstrated a dual-vector prime editing prototype for RBM20-related dilated cardiomyopathy (DCM), showing improved cardiac function in mouse models. 3. TN-501 Development: Preclinical studies of their Cas9 gene editing therapy for PLN-R14del-associated DCM showed effective prevention of protein aggregation and improved cardiac function at low doses. 4. Manufacturing Improvements: Established Sf9/rBV-based processes at 1000L scale and developed a proprietary HEK293-based system with improved yields and lower costs.

Tenaya Therapeutics (NASDAQ: TNYA) reported encouraging Q1 2025 results and clinical progress. The company shared positive interim data from the MyPEAK-1 trial of TN-201 for MYBPC3-associated HCM, showing good safety profile and improvements in patient conditions. The RIDGE study for PKP2-associated ARVC demonstrated significant disease burden and unmet needs.

Key financial highlights include $88.2 million in cash and investments as of March 31, 2025, plus $48.8 million raised through a public offering. The company reported a net loss of $26.9 million ($0.24 per share) and implemented cost-cutting measures to extend cash runway into H2 2026. R&D expenses were $21.1 million, down from $25.1 million year-over-year.

Important upcoming milestones include data readouts for both TN-201 and TN-401 clinical programs in H2 2025, with patient enrollment on track for both studies.

Tenaya Therapeutics (NASDAQ: TNYA) has presented interim data from its RIDGE™ natural history study of PKP2-associated ARVC at Heart Rhythm 2025. The study, involving over 175 participants, is the largest of its kind focusing on arrhythmogenic right ventricular cardiomyopathy caused by PKP2 gene mutations.

Key findings from 144 analyzed patients reveal:

• 83% of participants showed high-risk PVC counts despite standard treatments
• 60% demonstrated disease progression in heart function
• 93% show AAV9 neutralizing antibody titers ≤1:40, indicating eligibility for TN-401 gene therapy

The company is developing TN-401, a gene replacement therapy using AAV9 capsid to deliver functional PKP2 genes to heart muscle cells. Tenaya plans to report safety and biopsy data from the first cohort of the RIDGE-1 clinical trial in H2 2025.

Tenaya Therapeutics (NASDAQ: TNYA) presented interim data from its MyPEAK-1 Phase 1b/2 clinical trial of TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), at ACC.25. The trial's first cohort showed promising results with the 3E13 vg/kg dose:

• All three patients achieved NYHA Class I status, improving from their baseline severe condition
• Two patients showed improvements in hypertrophy measures
• Biopsy data confirmed robust TN-201 DNA presence and RNA expression
• MyBP-C protein levels increased in two patients
• Treatment was generally well-tolerated with mostly mild adverse events

The company is currently enrolling Cohort 2 patients at a higher dose of 6E13 vg/kg, with completion expected in 1H25 and initial data reporting in 2H25.