Tenaya Therapeutics, Inc. ((TNYA)) announced an update on their ongoing clinical study.
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Tenaya Therapeutics, Inc. is conducting a pivotal clinical study titled First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-201, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Myosin Binding Protein C Transgene, in Adults With MYBPC3 Mutation-associated Hypertrophic Cardiomyopathy (HCM). The study aims to evaluate the safety and tolerability of TN-201 in adults with symptomatic hypertrophic cardiomyopathy (HCM) caused by MYBPC3 gene mutations, marking a significant step in addressing this genetic heart condition.
The intervention being tested is TN-201, a genetic therapy delivered as a single intravenous dose. TN-201 is a recombinant adeno-associated virus serotype 9 (AAV9) containing the Myosin Binding Protein C (MYBPC3) transgene, designed to target the underlying genetic cause of HCM.
This study is interventional, non-randomized, and open-label, with a sequential intervention model. It consists of two escalating dose cohorts, aiming to enroll between 6 and 30 patients. The primary purpose is treatment, with no masking involved, allowing all participants to receive the active drug.
The study began on April 18, 2023, and is currently recruiting. The primary completion and estimated completion dates are yet to be disclosed, with the last update submitted on July 10, 2025. These timelines are crucial for tracking the study’s progress and potential market entry.
The advancement of this study could significantly impact Tenaya Therapeutics’ stock performance, as successful results may enhance investor confidence and position the company as a leader in genetic therapies for cardiac conditions. Competitors in the genetic therapy space will be closely monitoring these developments.
The study is ongoing, and further details are available on the ClinicalTrials portal.