Tenaya Therapeutics

At the Canaccord Growth Conference, Tenaya reported positive early safety and efficacy signals for gene therapies TN-201 and TN-401 and the reactivation of the small‑molecule program TN-301. Regulatory decisions on the design of approval‑relevant studies for TN-201 and TN-401, as well as details on TN-301, are expected in the fourth quarter and will determine further capital allocation. The company noted cash of roughly $78 million, expected to last into the third quarter of 2027, but stressed that additional financing will be required for the planned registration and Phase II studies. » Más en de.investing.com

Tenaya presented interim results from the phase 1b/2 RIDGE‑1 study: in six patients a single infusion of TN‑401 led to a mean reduction in premature ventricular contractions of about 60–67% and the treatment was reported to be well tolerated. Biopsies showed presence of TN‑401 DNA and stable to slightly improved PKP2 protein levels; common adverse events were transient increases in troponin or transaminases. The EMA has granted TN‑401 PRIME status. Financial analyses highlight stronger liquidity than debt but note negative free cash flow, while analyst price targets range between $2 and $8. » Más en de.investing.com

Tenaya Therapeutics received a warning from Nasdaq because the closing price was below $1.00 for 30 consecutive trading days; the company has until July 27, 2026 to raise the price to $1.00 or more for at least ten trading days. The board increased the shares reserved for the 2024 Inducement Equity Incentive Plan by 2,161,000 to a total of 3,361,000 shares. At the same time, Tenaya plans a $60 million capital raise (50 million units at $1.20) and announced that the FDA lifted the clinical hold on the MyPEAK-1 study of TN-201; interim results from the Phase 1b RIDGE-1 study were also released, after which analysts lowered their price targets but maintained buy ratings. » Más en de.investing.com