Welcome to our dedicated page for Tenaya Therapeutics news (Ticker: TNYA), a resource for investors and traders seeking the latest updates and insights on Tenaya Therapeutics stock.
Tenaya Therapeutics, Inc. (TNYA) is a clinical-stage biotechnology company pioneering gene therapies and regenerative approaches for heart disease. This news hub provides investors and medical professionals with official updates on clinical developments, financial disclosures, and scientific advancements.
Access real-time updates on TNYA's investigational programs targeting genetic cardiomyopathies through AAV-based gene delivery and cellular regeneration technologies. Our curated feed includes earnings reports, FDA submissions, partnership announcements, and peer-reviewed research findings.
Key coverage areas span Phase 1/2 trial results for MYBPC3-associated hypertrophic cardiomyopathy therapies, manufacturing facility expansions, intellectual property milestones, and presentations at major cardiology conferences. Bookmark this page for verified updates on Tenaya's progress in developing potentially curative cardiac treatments.
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.
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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