Business
Tenaya Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update
TN-201 Received Fast Track Designation from the FDA Dosing Complete in Phase 1 Clinical Trial of TN-301; Data Expected in Second Half 2023 Renowned
About this update from Tenaya Therapeutics, Inc.
[{"type":"text","content":"TN-201 Received Fast Track Designation from the FDA Dosing Complete in Phase 1 Clinical Trial of TN-301; Data Expected in Second Half 2023 Renowned Researchers Drs. Christine Seidman and Alex Marson Join Scientific Advisory Board Announces Formation of Technical Advisory Board with Deep Expertise in Gene Therapy Manufacturing SOUTH SAN FRANCISCO, Calif., May 10, 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 first quarter ended March 31, 2023. “Tenaya is making meaningful progress across multiple fronts of our business while maintaining a solid cash position. We are pleased to have recently received Fast Track designation for TN-201 and completed dosing in our Phase 1 trial of TN-301. We remain on track to achieve our 2023 development and regulatory milestones for TN-201, TN-301 and TN-401, including the release of clinical data for TN-301 in the second half of 2023,” said Faraz Ali, Chief Executive Officer of Tenaya. “In addition to our focus on achieving near-term catalysts, we continue to invest in our future. We look forward to highlighting the depth and breadth of our core capabilities at the upcoming ASGCT conference. We have also added leading industry and academic experts to our Scientific Advisory Board and to our newly created Technical Advisory Board. These efforts will collectively help Tenaya lay the foundation for commercial-ready manufacturing for our existing product candidates and support the expansion of Tenaya’s pipeline into new modalities, including gene editing, so that we can bring the promise of genetic medicines to individuals and families fighting heart disease.” Business and Program Updates TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)Tenaya received notification that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to TN-201. The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates intended to treat serious conditions and for which nonclinical data demonstrates the potential to address unmet medical need. In January 2023, the FDA n...