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FDA Lifts Hold on Tenaya’s MyPEAK-1 Trial

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FDA Lifts Hold on Tenaya’s MyPEAK-1 Trial

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Tenaya Therapeutics ( (TNYA) ) just unveiled an update.

On December 11, 2025, Tenaya Therapeutics announced that the FDA lifted the clinical hold on its MyPEAK-1 trial for TN-201 gene therapy, following amendments to the study protocol. The company also shared interim data from its RIDGE-1 trial for TN-401, showing promising safety and efficacy results, with no dose-limiting toxicities and improvements in electrical instability in patients.

The most recent analyst rating on (TNYA) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on Tenaya Therapeutics stock, see the TNYA Stock Forecast page.

Spark’s Take on TNYA Stock

According to Spark, TipRanks’ AI Analyst, TNYA is a Underperform.

Tenaya Therapeutics’ overall score is primarily impacted by its financial performance, characterized by pre-revenue status and high cash burn due to R&D expenses. Technical indicators highlight a bearish trend, with the stock trading below key moving averages and near oversold conditions. Valuation metrics reflect non-profitability and lack of dividend yield, typical for early-stage biotech firms.

To see Spark’s full report on TNYA stock, click here.

More about Tenaya Therapeutics

Tenaya Therapeutics is a clinical-stage biotechnology company focused on developing potentially curative therapies for heart disease. Their pipeline includes gene therapies like TN-201 for MYBPC3-associated hypertrophic cardiomyopathy and TN-401 for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, as well as other treatments for heart failure and related conditions.

Average Trading Volume: 3,518,258

Technical Sentiment Signal: Hold

Current Market Cap: $234.8M

Learn more about TNYA stock on TipRanks’ Stock Analysis page.

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