Business
Tenaya Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
Dosing of First Patient in Phase 1b Trial of TN-201 On Track to Occur in Q3 2023 Data from Phase 1 Clinical Trial of TN-301 Accepted for Presentation at HFSA
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"Dosing of First Patient in Phase 1b Trial of TN-201 On Track to Occur in Q3 2023 Data from Phase 1 Clinical Trial of TN-301 Accepted for Presentation at HFSA 2023 IND Application for TN-401 Anticipated in Second Half 2023 Second Quarter Cash and Investments of $152 Million; Runway to Fund Operations into First Half 2025 SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results and provided a corporate update for the second quarter ended June 30, 2023. “We are looking ahead to important near-term milestones across all our programs. Dosing the first patient in our first clinical trial for TN-201 will be a significant moment for our company and bring us one step closer to bringing much-needed solutions to those impacted by genetic HCM,” said Faraz Ali, Chief Executive Officer of Tenaya. “We are also looking forward to presenting healthy participant data from our TN-301 small molecule program and filing the IND for our TN-401 gene therapy candidate later this year. Our continued progress is supported by our unwavering commitment to fight heart disease on behalf of individuals and families.” Business and Program UpdatesTN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In April 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Tenaya’s lead gene therapy program, TN-201. Companies with therapies that receive the Fast Track designation are eligible for more frequent communication with the agency and may qualify for Accelerated Approval and Priority Review if relevant criteria are met.Tenaya anticipates dosing its first patient in the “MyPeak-1” Phase 1b multi-center, open-label, dose-escalation clinical trial of TN-201 during the third quarter of 2023 (ClinicalTrials.gov #NCT05836259). The Phase 1b trial is designed to assess the safety, tolerability and pharmacodynamics of a one-time intravenous infusion of TN-201 in symptomatic adults with MYBPC3-associated HCM. Initial data from the MyPeak-1 clinical trial are anticipated in 2024. In July 2023, Tenaya received notification from the U.S. Patent and Trademarks Office (USPTO) th...