Tenaya Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of therapeutics for cardiovascular diseases. It operates through its product platforms: gene therapy, cellular regeneration, and precision medicine. The company was founded by Deepak Srivastava, Benoit G. Bruneau, Bruce R. Conklin, Sheng Ding, Saptarsi Haldar, and Eric Olson in 2016 and is headquartered in South San Francisco, CA.
相关临床试验
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2016
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- The FDA granted Regenerative Medicine Advanced Therapy designation to TN-401, Tenaya Therapeutics' AAV9-based gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy. - The designation was supported by interim RIDGE-1 Phase 1b/2 data showing reduced daily rates of premature ventricular contractions and non-sustained ventricular tachycardias after a single infusion. - TN-401 already holds FDA Orphan Drug and Fast Track designations plus European Medicines Agency PRIME designation, and Tenaya plans a pivotal trial. - Tenaya expects to report additional RIDGE-1 data and provide an update on regulatory discussions regarding pivotal trial plans in the fourth quarter of 2026.
- Tenaya Therapeutics reported encouraging interim data from its RIDGE-1 Phase 1b/2 trial of TN-401 gene therapy for arrhythmogenic right ventricular cardiomyopathy, showing improved arrhythmia burden and good tolerability. - The FDA lifted the clinical hold on Tenaya's MyPEAK-1 Phase 1b/2a trial of TN-201 for MYBPC3-associated hypertrophic cardiomyopathy, allowing the company to resume dosing. - The company completed a $60 million equity offering of 50 million units at $1.20 per unit to fund ongoing development of its cardiac gene therapy programs. - Despite positive clinical developments, Tenaya's stock declined 37.44% following the dilutive equity offering, highlighting investor concerns about the company's financing needs.
- Tenaya Therapeutics announced positive interim data from the RIDGE-1 Phase 1b/2 trial of TN-401 gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). - The therapy demonstrated a favorable safety profile at the 3E13 vg/kg dose with no dose-limiting toxicities and showed robust transduction with increased PKP2 protein levels in two of three patients. - Clinically meaningful reductions in arrhythmia burden were observed, with PVC counts decreasing by 46% and 89% in the first two patients with over six months of follow-up. - The AAV9-based gene therapy addresses the underlying genetic cause of ARVC by delivering functional PKP2 genes to heart muscle cells, potentially offering a curative approach for this rare cardiac condition.
- The FDA has removed the clinical hold on Tenaya Therapeutics' MyPEAK-1 Phase 1b/2a trial of TN-201 gene therapy for MYBPC3-associated hypertrophic cardiomyopathy. - TN-201 is an AAV9-based gene therapy designed to address the underlying genetic cause of HCM by delivering a functional MYBPC3 gene via single intravenous infusion. - The trial targets approximately 120,000 patients in the US with MYBPC3-associated HCM, representing 20% of the overall HCM population. - Protocol amendments will standardize immunosuppressive regimen management before dosing resumes, with no expected impact on development timelines.
- The FDA has placed a clinical hold on Tenaya Therapeutics' TN-201 gene therapy trial for hypertrophic cardiomyopathy linked to MYBPC3 gene mutations. - The regulatory action requires protocol changes to standardize patient monitoring and immunosuppression drug management, based on previously reviewed safety data. - Despite the hold, Tenaya reports the therapy has been well tolerated with no new safety issues and expects no delays to planned data releases. - The company's shares dropped more than 20% in extended trading following the announcement of the clinical hold.
- Medera Inc. announced the appointment of three senior executives to strengthen its leadership team as the company advances its cardiac gene therapy programs through ongoing clinical trials. - The new appointments include Fubao Wang, Ph.D., as Chief Regulatory Officer and Chief Technical Officer at Sardocor, bringing over 28 years of pharmaceutical and biotech experience across gene therapy and regulatory affairs. - James Kim joins as Chief Corporate Officer with over 20 years of biopharmaceutical industry experience, having executed over 100 transactions totaling approximately $25 billion in financings and M&A deals. - Niharika Kamat, M.S., was appointed Vice President of Clinical Operations at Sardocor, bringing nearly 20 years of experience in global Phase 1-3 trials across cardiovascular and rare disease indications.
- Tenaya Therapeutics presented interim data from MyClimb, the largest natural history study of pediatric MYBPC3-associated hypertrophic cardiomyopathy with 213 participants under 18 years old. - The study revealed that 93% of participants had nonobstructive HCM with no approved treatments, and genetic inheritance patterns significantly predict disease severity and outcomes. - Left Ventricular Mass Index emerged as a significant predictor of risk, with every 10-unit increase associated with 10% higher hazard of serious events. - Homozygous patients showed the most severe outcomes with nearly all requiring heart transplant or dying before age one, highlighting urgent need for disease-modifying therapies.
- Industry experts at the 2025 Clinical Trial Supply West Coast conference identified risk management as critical for pharmaceutical supply chains amid rising tariffs and AI disruption. - President Trump's tariffs on pharmaceutical imports, including a 15% rate on EU products with potential increases to 250%, are forcing companies to develop backup sourcing strategies. - Artificial intelligence is accelerating the shift from site-centric to patient-centric clinical trials, though human input remains essential for interventional trials with scarce data. - Regulatory changes including FDA guidance on decentralized trials and diversity requirements are reshaping clinical trial operations and supply chain planning.
• Tenaya Therapeutics has successfully completed a $52.5 million units offering to support the advancement of its innovative cardiac gene therapy programs. • The financing will primarily accelerate the development of treatments targeting genetic heart diseases and heart failure, strengthening the company's position in cardiovascular therapeutics. • This strategic funding round demonstrates continued investor confidence in Tenaya's gene therapy platform and its potential to address significant unmet needs in cardiac medicine.
- Tenaya Therapeutics has announced plans to offer units comprising common stock and two series of warrants to strengthen its financial position. - The biotechnology company has engaged Leerink Partners and Piper Sandler as joint bookrunning managers to oversee the proposed public offering. - The offering's completion remains subject to market conditions, with final terms and size yet to be determined.
