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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) has reported promising early data from the first cohort of the MyPEAK-1 Phase 1b/2 clinical trial of TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM). The trial's preliminary results from three patients at the 3E13 vg/kg dose showed that TN-201 was generally well-tolerated with:
- Detectable vector DNA in the heart
- Evidence of transgene RNA expression
- Increasing TN-201 mRNA and MyBP-C protein levels over time
- Stable or improved circulating biomarkers of cardiac muscle strain and injury
The first patient reached 52 weeks, the second 40 weeks, and the third 12 weeks of follow-up. Additional data readouts from Cohort 1 and the higher dose Cohort 2 are expected in 2025.
Tenaya Therapeutics (NASDAQ: TNYA) announced it will present initial data from Cohort 1 of the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) on December 17, 2024. The company will host a conference call and webcast at 8:00 a.m. ET to discuss the results. The presentation will be accessible through the company's website, with a replay available afterward in the Investor Relations section.
Tenaya Therapeutics (NASDAQ: TNYA) has dosed the first patient in its RIDGE-1 Phase 1b clinical trial of TN-401, a gene therapy treatment for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC). The trial, currently enrolling at six U.S. centers, will assess safety and efficacy of a one-time intravenous infusion in up to fifteen adults with PKP2-associated ARVC. TN-401 uses AAV9 capsid to deliver functional PKP2 genes to heart cells, aiming to address the underlying cause of the disease. Initial clinical data is expected in 2025. The first dose being tested is 3E13 vg/kg, which showed near maximal efficacy in preclinical studies.
Tenaya Therapeutics (NASDAQ: TNYA) has granted stock options to two new non-executive employees as employment inducements. The options allow purchase of 12,000 total shares at $1.97 per share, matching the November 15, 2024 closing price. These ten-year options vest over four years, with 25% vesting after one year and the remainder vesting monthly at 1/48th of the original shares. The grants were made under the company's 2024 Inducement Equity Incentive Plan in accordance with NASDAQ Rule 5635(c)(4).
Tenaya Therapeutics (NASDAQ: TNYA) reported Q3 2024 financial results and provided updates on its gene therapy programs. The company completed dosing of the first three patients in Cohort 1 of the MyPEAK-1 trial for TN-201, with the Data Safety Monitoring Board endorsing dose escalation to Cohort 2. Initial data from Cohort 1 will be reported in December 2024. The company reported a net loss of $25.6 million ($0.30 per share) and had cash and investments of $79.5 million as of September 30, 2024, sufficient to fund operations into second half of 2025. R&D expenses were $20.4 million, down from $23.1 million in Q3 2023.
Tenaya Therapeutics has provided updates on its TN-201 gene therapy program for MYBPC3-associated hypertrophic cardiomyopathy (HCM). The company has completed dosing of the first three patients in Cohort 1 of the MyPEAK-1 clinical trial at the 3E13 vg/kg dose, with no unexpected events or toxicities observed. An independent Data and Safety Monitoring Board (DSMB) has recommended proceeding with dose escalation to 6E13 vg/kg for Cohort 2, which is now enrolling.
Tenaya has implemented protocol changes, including adding a baseline biopsy, expanding eligibility criteria, and increasing the potential number of patients in the dose expansion portion. The company plans to report initial data from Cohort 1 in December 2024, focusing on safety, tolerability, and biomarker analyses.
Additionally, Tenaya presented data on the disease burden for children and adolescents with MYBPC3-associated HCM, highlighting the high cumulative lifetime risk of severe events and the need for new genetic medicines.
Tenaya Therapeutics (NASDAQ: TNYA), a clinical-stage biotech company focused on heart disease therapies, has announced its participation in three upcoming investment conferences. CEO Faraz Ali will represent the company at:
- Morgan Stanley 22nd Annual Global Healthcare Conference (Sept. 5, 2024)
- 10th Annual World Medical Innovation Forum (Sept. 23, 2024)
- Chardan's 8th Annual Genetic Medicines Conference (Oct. 1, 2024)
The events will feature fireside chats and panel discussions. Live and archived webcasts of the fireside chats will be available on Tenaya's website for approximately 30 days after each conference.
Tenaya Therapeutics (NASDAQ: TNYA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Received Rare Pediatric Disease Designation for TN-201 for MYBPC3-associated HCM
2. UK clearance to initiate clinical testing of TN-401 for PKP2-Associated ARVC
3. Established $45 Million Credit Facility with Silicon Valley Bank
4. Anticipates sharing interim Phase 1b results for TN-201 in H2 2024
5. Plans to begin dosing patients in TN-401 RIDGE-1 trial in Q4 2024
6. Q2 2024 financial results: R&D expenses $22.6M, G&A expenses $8.2M, net loss $29.4M ($0.34 per share)
7. Cash position of $99.3M as of June 30, 2024, expected to fund operations into H2 2025
Tenaya Therapeutics, a clinical-stage biotech focused on heart disease therapies, announced significant leadership updates. Kathy Ivey, Ph.D., is promoted to Senior Vice President of Research, taking charge of all non-clinical research and discovery. Timothy Hoey, Ph.D., steps down as Chief Scientific Officer but will continue as an advisor and join the Scientific Advisory Board (SAB). Barry J. Byrne, M.D., Ph.D., a pediatric cardiologist and genetic therapy expert, is appointed to the SAB. Additionally, Jin-Long Chen, Ph.D., resigns from the Board of Directors to pursue other commitments.
Ivey, instrumental in Tenaya's formation, has led projects like TN-201 and TN-401 gene therapies. Byrne's addition brings expertise in genetic therapies for cardiomyopathies affecting young people. These leadership changes aim to strengthen Tenaya's mission to develop curative therapies for heart disease.
On June 18, 2024, Tenaya Therapeutics, a clinical-stage biotechnology company focused on developing therapies for heart disease, announced its participation in the TD Cowen Genetic Medicines & RNA Summit. The company's CEO, Faraz Ali, will present on June 21, 2024, at 11:20 am ET. The live presentation will be webcast, accessible from the Investors section of Tenaya's website, with a replay available for 30 days post-conference.
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