On Wednesday, H.C. Wainwright reaffirmed a Buy rating and an $18.00 price target for Tenaya Therapeutics Inc (NASDAQ:TNYA), following the release of initial data from its Phase 1b MyPeak-1 study. The stock, currently trading at $1.41, has seen significant volatility, with analyst price targets ranging from $6 to $40.
According to InvestingPro data, the company maintains a strong analyst consensus recommendation of 1.33, indicating robust institutional confidence despite recent market challenges. The study is evaluating TN-401, an AAV-based gene therapy for the treatment of MYBPC3-associated hypertrophic cardiomyopathy (HCM). The data, which was revealed on December 17, includes findings from the first three patients enrolled in the study.
The MyPeak-1 study is an open-label, multi-center trial that includes a dose escalation and expansion phase, aiming to enroll up to 24 patients. The trial spans a 52-week period, with a subsequent four-year follow-up to assess safety and efficacy. The latest results show that the safety profile of TN-401 is consistent with other AAV gene therapies, with no cardiac adverse events (AEs) reported and normal ejection fraction levels maintained.
Liver enzyme elevations observed were manageable and reversible, which is in line with expectations for AAV gene therapy treatments. Biopsy assessments have shown evidence of cardiac transduction, with durable TN-201 RNA expression and protein levels increasing over time. Specifically, for Patient 1, protein levels have increased from Week 8 to Week 52, which correlates with changes in mRNA.
The initial data has provided insights into the potential for clinical improvement or stabilization in patients with severe HCM, with indications of progressive improvement in multiple parameters.
Despite a negative reaction from the stock market to the initial data release, with the stock declining over 61% in the past week, H.C. Wainwright emphasizes the importance of the early findings and the potential for TN-401 to demonstrate clinical benefits over time. InvestingPro analysis suggests the stock is currently undervalued, with a Fair Value assessment indicating potential upside. The company maintains a healthy balance sheet with more cash than debt and a current ratio of 5.27, providing runway for continued development.
The firm has reiterated its Buy rating and $18 price target for Tenaya Therapeutics, signaling confidence in the ongoing development of TN-401. With a market capitalization of $111.7 million and an overall Fair financial health rating from InvestingPro, investors can access 13 additional ProTips and comprehensive financial metrics to make more informed investment decisions about TNYA's potential.
In other recent news, Tenaya Therapeutics has seen significant progress in its gene therapy program. The company reported positive early data from its MyPEAK-1 clinical trial for TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy, with the Data Safety Monitoring Board approving an increase in dosage for the second cohort of the study. Furthermore, Tenaya has initiated a Phase 1b study of another gene therapy, TN-401, aimed at treating arrhythmogenic right ventricular cardiomyopathy, with initial data expected in 2025.
The company has also introduced a new 2024 Inducement Equity Incentive Plan, permitting the issuance of 1,200,000 shares of common stock. However, Tenaya announced the upcoming departure of Leone Patterson, its Chief Financial and Business Officer, and has begun the search for a new CFO.
Analyst firms such as H.C. Wainwright, Piper Sandler, Canaccord Genuity, Leerink Partners, and William Blair have maintained a positive outlook on Tenaya, with H.C. Wainwright and Piper Sandler retaining their Buy and Overweight ratings respectively.
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