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Tenaya Therapeutics, Inc. (NASDAQ: TNYA) is a clinical-stage biotechnology company dedicated to discovering, developing, and delivering potentially curative therapies that address the underlying causes of heart disease. Founded in 2016 and headquartered in South San Francisco, Tenaya Therapeutics leverages its integrated platforms in Gene Therapy, Cellular Regeneration, and Precision Medicine to advance a pipeline of novel therapeutic candidates targeting both rare genetic cardiovascular disorders and more prevalent heart conditions.
Tenaya's flagship programs include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor for heart failure with preserved ejection fraction (HFpEF). In late October 2023, the company announced the U.S. FDA clearance of its Investigational New Drug (IND) application for TN-401, initiating the RIDGE-1 Phase 1b clinical trial to evaluate its safety, tolerability, and efficacy.
Tenaya is a preclinical-stage company but has made significant strides. Its gene therapy TN-401 aims to treat ARVC by delivering a fully functional PKP2 gene to restore protein levels necessary for heart muscle function. The company also focuses on genetic mutations responsible for heart diseases, aiming to reverse or halt disease progression efficiently.
The company’s commitment to innovation extends to its robust pipeline and strategic collaborations, ensuring progress in addressing unmet needs in cardiac care. With a fully operational Genetic Medicines Manufacturing Center, Tenaya can produce clinical trial material at scale, highlighting its readiness to transition groundbreaking research into clinical applications.
For the latest updates, detailed financial results, and corporate announcements, visit their official website at www.tenayatherapeutics.com.
Tenaya Therapeutics (NASDAQ: TNYA) reported its Q1 2024 financial results, revealing a net loss of $32.2 million, or $0.40 per share. The company raised $47 million in net proceeds, extending its cash runway to the second half of 2025. R&D expenses were $25.1 million, slightly down from $25.6 million in Q1 2023, while G&A expenses remained flat at $8.7 million.
Tenaya continues to focus on its gene therapy programs, expecting initial data from its TN-201 Phase 1b trial in H2 2024 and has activated clinical sites for its TN-401 Phase 1b trial. In line with cost containment measures, Tenaya plans to cut its workforce by 22%.
Recent academic publications highlight the potential of their TN-301 for heart failure and TN-401 for ARVC. With strategic hires and ongoing innovations, Tenaya aims to meet critical milestones in its clinical programs.
Tenaya Therapeutics, Inc. will showcase its advances in capsid engineering, gene editing, and manufacturing at the ASGCT 27th Annual Meeting. The company will present seven abstracts highlighting its capabilities in genetic medicines for heart disease. Tenaya's pipeline includes clinical-stage gene therapies for cardiomyopathies and research on gene therapy, gene editing, and cardiac cell regeneration using AAV as a delivery vehicle. The presentations will cover capsid engineering insights, gene editing efforts, and manufacturing process optimizations to improve AAV-based gene therapies' safety and efficacy.
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