Last Friday, Tenaya Therapeutics, Inc. (NASDAQ: TNYA) released its third-quarter financial results, which were well received by the market. After rising 10.4% during normal trading, TNYA shares rose 6.88% to $2.95 in after-hours trade.
Tenaya Reported Improvements and Positive Advancements Gene Therapy Initiative
Tenaya (TNYA) was able to post improvements as its net loss dropped from $29.1 million, or $0.39 per share, to $25.6 million, or $0.30 per share, the year before. Its main gene therapy, TN-201, which targets hypertrophic cardiomyopathy (HCM), has shown significant progress. The independent Data Safety and Monitoring Board (DSMB) approved a dosage escalation to Cohort 2 in the MyPEAK-1 study after the company finished treating the first three patients in Cohort 1 without experiencing any adverse effects.
A significant milestone that might highlight TN-201’s potential as a new therapy for HCM is the company’s anticipated December 2024 release of early clinical results for Cohort 1. In line with regulatory guidance, TNYA adjusted the MyPEAK-1 protocol to allow for deeper insights into TN-201’s efficacy.
Extension of Intellectual Property and Clinical Trials
Tenaya’s RIDGE-1 clinical trial, assessing TN-401 for arrhythmogenic right ventricular cardiomyopathy (ARVC) due to PKP2 mutations, has shown strong early momentum with six activated sites globally and over 20 additional sites screening potential participants across six countries. This open-label, dose-escalation study aims to evaluate the therapy’s safety and tolerability, contributing to a more robust dataset for Tenaya’s gene therapy pipeline.
In October 2024, TNYA achieved a key intellectual property milestone when the U.S. Patent and Trademark Office granted Patent No. 12,104,165. This patent covers a treatment method for ARVC using AAV9 virions encoding the PKP2 protein, extending exclusive rights for Tenaya’s PKP2 gene therapy until at least 2040.
Future Outlook
Looking ahead, Tenaya anticipates further updates on both TN-201 and TN-401 therapies, with safety and biomarker data expected from MyPEAK-1’s Cohort 1. Additionally, presentations at the September HCM Society’s Scientific Sessions highlighted its commitment to addressing the high disease burden in MYBPC3-associated pediatric HCM. These strategic advancements position TNYA to expand its therapeutic portfolio in cardiomyopathies.