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SOUTH SAN FRANCISCO - Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a clinical-stage biotech with a current market capitalization of $114.5 million, has completed enrollment in both dose cohorts of its MyPEAK-1 Phase 1b/2 clinical trial for TN-201, a gene therapy targeting hypertrophic cardiomyopathy (HCM), the company announced Wednesday. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.68, indicating robust short-term financial stability.
The biotech firm also reported dosing the first patient in Cohort 2 of its RIDGE-1 Phase 1b clinical trial of TN-401 for arrhythmogenic right ventricular cardiomyopathy (ARVC).
Independent Data Safety and Monitoring Boards (DSMBs) for both trials have endorsed proceeding per protocol, indicating favorable tolerability profiles for both gene therapies.
"Safety is paramount, and this milestone reinforces the favorable tolerability profile emerging for both TN-201 and TN-401," said Whit Tingley, Tenaya’s Chief Medical Officer, in a press release statement.
Initial data from the first three patients receiving TN-201 at the 3E13 vg/kg dose level showed the therapy reached cardiomyocytes with robust RNA expression. Increased MyBP-C protein levels were observed in two patients with serial biopsies. All three patients achieved New York Heart Association Class I post-treatment, indicating resolution of heart failure symptoms.
For the RIDGE-1 trial, the DSMB reviewed available data and endorsed dose escalation to the 6E13 vg/kg level while allowing expansion of Cohort 1 enrollment. The company has already dosed the first patient in the higher dose cohort.
Tenaya expects to report follow-up data from MyPEAK-1 Cohort 1 and initial data from Cohort 2 in the fourth quarter of 2025. Initial data from RIDGE-1 Cohort 1 is also expected in the fourth quarter, focusing on safety, tolerability, and cardiac biopsy analyses.
Both TN-201 and TN-401 have received Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration.
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