Tenaya Therapeutics, Inc. - TNYA STOCK NEWS

Tenaya Therapeutics (TNYA) announced the FDA's clearance for its IND application to start clinical trials for TN-201, aimed at treating hypertrophic cardiomyopathy (HCM) caused by MYBPC3 mutations. The Phase 1b trial will dose patients beginning Q3 2023, with initial data expected in 2024. Tenaya is also advancing its TN-301 and TN-401 programs, with milestones projected for 2023. The company has extended its cash runway into the first half of 2025, supported by a strong cash position of $149.5 million plus $76.8 million from a recent public offering.

Tenaya Therapeutics (TNYA) announced the appointment of Amy Burroughs to its Board of Directors, enhancing its leadership team as it advances its pipeline in heart disease therapies. Burroughs, who has over 20 years of experience in drug development, is expected to contribute to Tenaya’s mission of discovering and commercializing novel genetic therapies. This addition follows the departure of Eli Casdin, who stepped down to focus on other commitments after more than three years of service. Tenaya aims to solidify its position in the biotechnology sector.

Tenaya Therapeutics has received FDA orphan drug designation for its gene therapy candidate TN-401, targeted at treating genetic arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by PKP2 gene mutations. This designation, the first for a gene therapy for ARVC, provides access to development incentives. TN-401 is designed to deliver a healthy PKP2 gene copy via a single intravenous dose. The company plans to submit an IND application to the FDA in 2023, while also initiating a global study on ARVC mutation carriers to gather clinical data.

Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company focused on therapies for heart disease, will present at the Piper Sandler 34th Annual Healthcare Conference in New York from November 29 to December 1, 2022. The company will participate in a panel discussion titled 'Heart to Heart with CV Players to Discuss 2023 Outlook' on November 29 at 2:30 p.m. ET and a fireside chat on November 30 at 8:30 a.m. ET. A webcast of the event can be accessed on Tenaya’s website, with a replay available for 30 days after.

Tenaya Therapeutics, Inc. (TNYA) announced a public offering of 22,613,307 shares at $2.60 each, raising approximately $75 million, with a 30-day option for underwriters to purchase an additional 4,327,500 shares. The offering includes pre-funded warrants for 6,236,693 shares at $2.599. The transaction, managed by Morgan Stanley and Piper Sandler, is set to close on or about November 21, 2022. Proceeds are intended to support the development of therapies for heart disease. However, investors should be aware of potential dilution from the offering.

Tenaya Therapeutics (TNYA) plans to offer $75 million in common stock through an underwritten public offering, along with the option for an additional $11.25 million. The offering will be managed by Morgan Stanley and Piper Sandler, with pre-funded warrants also available. The proceeds are intended for curative therapies targeting heart disease. This offering is contingent on market conditions, and there's no guarantee on its completion or terms. Full details will be provided in a prospectus supplement filed with the SEC.

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.