Tag: TNYA Stock Price

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.

Following a crucial update regarding its clinical trials, shares of Tenaya Therapeutics, Inc. (NASDAQ: TNYA) have experienced a notable increase on the US stock charts. TNYA stock rose 22.86% to conclude the previous session at $2.15, underscoring investor confidence in its ongoing research and development efforts.

Tenaya Shared Clinical Trial Progress

With an emphasis on the gene therapy TN-201, Tenaya Therapeutics (TNYA) gave updates on its Phase 1b/2 MyPEAK-1 clinical study. The goal of this novel therapy is to cure myosin-binding protein C or MyBP-C-associated HCM (hypertrophic cardiomyopathy), a cardiac disorder caused by insufficient myosin-binding protein C levels.

Profile of Safety and Tolerability

Determining the TN-201 gene therapy’s safety profile is the main objective of the MyPEAK-1 study. According to Tenaya Therapeutics, the treatment showed no unanticipated negative events and a satisfactory tolerability profile at a dose of 3E13 vg/kg.

Encouragingly, the Data and Safety Monitoring Board (DSMB) has recommended progressing to dose escalation and has endorsed the expansion of eligibility criteria, allowing Tenaya to investigate TN-201’s effectiveness in diverse patient populations. Protocol adjustments have been made, including a baseline biopsy and an increased participant pool, which now includes patients with obstructive HCM.

Future Developments

The initial dosing of the first three patients in Cohort 1 at the 3E13 vg/kg dose has been successfully completed, with no significant adverse events reported. The DSMB’s review confirmed a safety and tolerability profile consistent with existing AAV gene therapies at this dosage. Following this, enrollment for Cohort 2 is currently underway, which will escalate the dosage to 6E13 vg/kg.

Tenaya Therapeutics anticipates sharing initial data from Cohort 1 in December, focusing on safety, tolerability, cardiac biopsy analyses, and changes in cardiac biomarkers. Additionally, TNYA’s MyPEAK-1 trial aims to gather comprehensive data on TN-201’s impact on imaging biomarkers, heart function, exercise capacity, functional status, and overall patient quality of life.