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SOUTH SAN FRANCISCO - Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company focused on treating heart diseases, has reported positive preclinical data for its gene therapy candidate TN-201, aimed at treating Myosin-Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM), as published in Nature Communications. The company, currently valued at $103.5 million, has attracted strong analyst interest, with price targets ranging from $3 to $40 per share. According to InvestingPro data, three analysts have recently revised their earnings expectations upward for the upcoming period.
HCM is often caused by variants in the MYBPC3 gene, which lead to insufficient levels of MyBP-C protein, the most common genetic cause of the condition. TN-201 is an adeno-associated virus serotype 9 (AAV9)-based gene therapy designed to deliver a working MYBPC3 gene to heart muscle cells. The preclinical studies showed that TN-201 led to dose-dependent increases in MyBP-C protein and improved cardiac function, including the reversal of left ventricular hypertrophy, a key feature of HCM.
Currently, TN-201 is being evaluated in Tenaya’s ongoing MyPEAK-1 Phase 1b/2 clinical trial at doses of 3x1013 vg/kg and 6x1013 vg/kg. Kathy Ivey, Ph.D., Senior Vice President of Research at Tenaya Therapeutics, expressed optimism about the therapy’s potential to alter the treatment landscape for patients with this genetic heart condition. InvestingPro analysis shows the company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 4.22, though it is rapidly burning through its cash reserves.
Whit Tingley, M.D., Ph.D., Chief Medical Officer at Tenaya, highlighted the consistency of TN-201 in achieving transduction and expression across preclinical studies. The company anticipates presenting additional data from the first cohort of patients in the MyPEAK-1 clinical trial at the American College of Cardiology Scientific Sessions, with initial data from the high-dose cohort expected in the latter half of the year.
The preclinical research involved various studies, including those on human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs), and tested a mouse surrogate of TN-201 (mTN-201) in Mybpc3 knock-out mice. The treatment resulted in sustained increases in Mybpc3 RNA and MYBPC3 protein expression, decreased cardiac biomarkers associated with fibrosis and heart failure, improved cardiac function, heart remodeling, and extended survival.
The MYBPC3-associated HCM affects approximately 120,000 patients in the United States, often leading to severe and progressive conditions in adults, teens, children, and infants. Currently, there are no approved therapeutics that address the genetic cause of HCM. With the next earnings report scheduled for May 7, 2025, investors following this potential breakthrough therapy can access comprehensive financial analysis and 13 additional exclusive insights through InvestingPro’s detailed coverage of Tenaya Therapeutics.
This article is based on a press release statement.
In other recent news, Tenaya Therapeutics reported its fourth-quarter 2024 earnings, revealing a loss per share of ($0.28) and a full-year 2024 loss of ($1.31), slightly outperforming analyst expectations. The company concluded the year with $61.4 million in cash reserves, bolstered by an additional $48.89 million from a recent financing round, which is expected to sustain operations into mid-2026. Canaccord Genuity and H.C. Wainwright both revised their price targets for Tenaya, lowering them to $6.00 and $5.00, respectively, while maintaining a Buy rating. Tenaya recently announced a public offering of common stock and warrants, with Leerink Partners and Piper Sandler serving as joint bookrunning managers. Additionally, the company received an $8 million grant from the California Institute of Regenerative Medicine to support its ongoing Phase 1b RIDGE-1 study of the TN-401 gene therapy. The clinical trial aims to treat PKP2-associated arrhythmogenic right ventricular cardiomyopathy and has enrolled over 100 participants across 18 sites. Tenaya also appointed Mr. Tomohiro Higa as the Interim Principal Accounting Officer and repriced stock options for CEO Faraz Ali to retain and motivate him. The company’s pipeline includes promising gene therapies TN-201 and TN-401, with initial data from ongoing studies expected in 2025.
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