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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 (TNYA) has extended its cash runway to mid-2024, concluding Q3 2022 with $149.5 million in cash and equivalents. The company initiated dosing for its Phase 1 clinical trial of TN-301, with results anticipated in 2023. Tenaya also plans to submit an Investigational New Drug application for TN-201 by year-end 2022 and received a patent for TN-201, expiring no earlier than 2041. R&D expenses totaled $23.8 million, with a net loss of $30.7 million, or $0.74 per share.
Tenaya Therapeutics (NASDAQ: TNYA) announced participation in the American Heart Association Scientific Sessions on November 5-7, 2022. The company will present research demonstrating the efficacy of its HDAC6 inhibitor TN-301 in treating heart failure with preserved ejection fraction (HFpEF). The study compares TN-301 to empagliflozin, revealing comparable efficacy in a mouse model. This highlights TN-301's potential as a first-in-class treatment targeting HFpEF, a condition affecting 50% of heart failure patients.
Tenaya Therapeutics (NASDAQ: TNYA) is set to present preclinical data for its gene therapy candidate, TN-201, at the inaugural Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on September 30, 2022. The presentation will focus on MYBPC3 gene mutations, a leading cause of hypertrophic cardiomyopathy (HCM), responsible for ~20% of cases. The data indicates potential for TN-201 to reverse cardiac dysfunction. Tenaya aims to submit an Investigational New Drug application for TN-201 in late 2022.
Tenaya Therapeutics, a clinical-stage biotechnology company focused on heart disease, announced CEO Faraz Ali's upcoming participation in two key conferences. He will engage in a fireside chat at Chardan's 6th Annual Genetic Medicines Conference on October 4, 2022, at 11:00 a.m. ET. Additionally, Ali will present at the Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa on October 11, 2022, at 11:45 a.m. PT, followed by a panel discussion on October 13, 2022. Webcasts will be available on Tenaya's website for those unable to attend.
Tenaya Therapeutics, a clinical-stage biotechnology company, announced its participation in two upcoming investor conferences. The first event is the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, featuring a fireside chat at 3:30 p.m. ET. The second is the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, where the company will present at 3:00 p.m. ET. Webcasts of both events will be available on Tenaya's website for 30 days post-conference.
Tenaya Therapeutics (NASDAQ: TNYA) announced the FDA's clearance of its Investigational New Drug (IND) application for TN-301, its small molecule inhibitor targeting heart failure with preserved ejection fraction (HFpEF). This marks a significant step as Tenaya begins its first-in-human Phase 1 clinical trial in healthy adults. HFpEF affects over three million people in the U.S., with limited treatment options available. The trial will evaluate the safety and tolerability of TN-301, paving the way for potential therapeutic advancements in heart disease.
Tenaya Therapeutics (TNYA) reported its Q2 2022 financial results and corporate updates, revealing a net loss of $28.4 million or $0.69 per share. The company is on track for Investigational New Drug (IND) submissions for TN-201 and TN-301 in the second half of 2022. Their Genetic Medicines Manufacturing Center has launched, allowing cGMP production for upcoming trials. Notably, the company secured a $1 million grant for cellular reprogramming research and presented promising preclinical data for multiple pipeline programs, affirming its commitment to innovative heart disease therapies.
Tenaya Therapeutics (NASDAQ: TNYA) announced significant advancements in heart disease treatment, focusing on its lead candidate, TN-301, a selective HDAC6 inhibitor for heart failure with preserved ejection fraction (HFpEF). The preclinical study published in Science Translational Medicine demonstrates that HDAC6 inhibition protects heart muscle cells and enhances cardiac function. Tenaya aims to file an Investigational New Drug application with the FDA in the second half of 2022, marking a key step towards clinical trials for TN-301.
Tenaya Therapeutics announced the operational launch of its Genetic Medicines Manufacturing Center in Union City, California. This 94,000 sq. ft. facility will support production of gene therapies for heart disease, focusing on TN-201 and TN-401. With a capacity of producing at a 1000L scale, the center aims to enhance manufacturing capabilities and control over product quality. The company plans to file IND applications for TN-201 and TN-401 with the FDA in 2023, marking a significant step in its development of curative therapies.
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