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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) announced the presentation of preclinical data for its TN-301 program at the European Society of Cardiology Heart Failure conference scheduled for May 21-24, 2022. TN-301, an HDAC6 inhibitor, is in development for heart failure with preserved ejection fraction (HFpEF), a condition affecting over three million patients in the U.S. The data reveals TN-301's ability to reduce cardiac fibrosis and enhance mitochondrial function, showing comparable efficacy to empagliflozin. An IND application to the FDA is anticipated in the second half of 2022.
Tenaya Therapeutics (TNYA) announced significant updates in its recent quarterly report. The company received Orphan Medicinal Product designation for TN-201, aimed at treating genetic hypertrophic cardiomyopathy. TN-401 showed promising preclinical results at Heart Rhythm 2022 for genetic arrhythmogenic right ventricular cardiomyopathy. Financially, Tenaya reported a net loss of $31.1 million or $0.75 per share for Q1 2022, with cash reserves of $213.5 million, expected to last until at least H2 2023.
Tenaya Therapeutics (NASDAQ: TNYA) announced preclinical data presentations for its gene therapy candidates, TN-401 and DWORF, at the ASGCT 25th Annual Meeting in Washington, D.C., on May 16-19, 2022. TN-401 targets PKP2 gene mutations linked to arrhythmogenic right ventricular cardiomyopathy (ARVC), potentially affecting over 70,000 U.S. patients. Tenaya plans to file an Investigational New Drug application for TN-401 in 2023. The DWORF program, aimed at genetic dilated cardiomyopathy, is currently in candidate selection. The press also highlighted advancements in capsid engineering to improve gene therapy delivery.
Tenaya Therapeutics (TNYA) announced that its TN-401 gene therapy program for arrhythmogenic right ventricular cardiomyopathy (ARVC) will present preclinical results at the Heart Rhythm Society's annual meeting on May 1, 2022. TN-401 addresses PKP2 gene mutations affecting over 70,000 patients in the U.S., designed to deliver a healthy PKP2 gene via a single intravenous dose. The company is on track to submit an Investigational New Drug application (IND) in 2023 and plans to support a global study for ARVC.
Tenaya Therapeutics (NASDAQ: TNYA) announces participation in two investor conferences focusing on heart disease therapies. Key events include:
- H.C. Wainwright Gene Therapy and Gene Editing Conference: March 30, 2022, 7:00 a.m. ET (on demand)
- Chardan 6th Annual Genetic Medicines Manufacturing Summit: April 26, 2022, 1:00 p.m. ET
Webcasts for both fireside chats will be accessible on Tenaya’s website for about 30 days post-conference.
Tenaya Therapeutics, Inc. (NASDAQ: TNYA) reported significant progress in 2021, marking milestones in research and manufacturing as it transitions into a clinical-stage company. The fourth-quarter report indicated a net loss of $72.7 million, or $4.10 per share, compared to $38.4 million, or $39.50 per share, in 2020. The company strengthened its leadership team with notable appointments and expects to submit several IND applications to the FDA in 2022 and 2023. As of December 31, 2021, Tenaya's cash reserves stood at $251.3 million, supporting operations into the second half of 2023.
Tenaya Therapeutics, a biotechnology firm focused on heart disease therapies, has announced its participation in several investor conferences. Key events include the Cowen 2nd Annual Genetic Medicines Summit on February 3, 2022, and the SVB Leerink Global Healthcare Conference on February 18, 2022. The company aims to develop curative treatments addressing genetic and prevalent heart conditions through gene therapy, cellular regeneration, and precision medicine. Founded by leading scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is committed to advancing heart disease treatment.
Tenaya Therapeutics (NASDAQ:TNYA) has selected TN-401 as a candidate gene therapy for treating genetic Arrhythmogenic Right Ventricular Cardiomyopathy (gARVC) caused by PKP2 gene mutations, which affect over 70,000 patients in the U.S. Additionally, the company plans to submit IND applications for TN-201 and TN-301 in the latter half of 2022. Tenaya has appointed Jennifer Drimmer as General Counsel, bringing over 17 years of experience. The company aims to advance several therapeutic candidates towards clinical trials while enhancing its operational capabilities.
Tenaya Therapeutics (NASDAQ: TNYA) announced two key appointments: Karah Parschauer to its Board of Directors and Joanna Auch as Senior VP of People and Culture. These appointments aim to strengthen Tenaya's leadership amid its transition to a public company with over 100 employees. CEO Faraz Ali highlighted that both individuals bring valuable experience and will enhance the company's capabilities in drug development for heart disease. Parschauer has extensive biopharmaceutical experience and previously held roles at Ultragenyx, while Auch has over 15 years in HR.
Tenaya Therapeutics, Inc. (NASDAQ:TNYA) announced significant changes to its Board of Directors, with the appointment of Dr. June Lee, who brings extensive experience in cardiovascular drug development. Dr. Lee was previously the Founder and CEO of Esker Therapeutics and held senior roles at MyoKardia and Genentech. She succeeds Dr. JJ Kang, who steps down after five years to focus on other ventures. The move reflects Tenaya's evolution towards becoming a clinical-stage company as it aims to advance therapies for heart disease.
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