Vistagen expects phase 3 trial results by 2026

SOUTH SAN FRANCISCO, Calif. - Vistagen Therapeutics Inc. (NASDAQ: VTGN), a biopharmaceutical company with a market capitalization of $74.5 million engaged in the development of treatments for nervous system disorders, announced updates on its PALISADE Phase 3 program. According to InvestingPro data, the company maintains a "FAIR" overall financial health score, with particularly strong liquidity metrics. The company’s PALISADE-4 Phase 3 trial evaluating the drug fasedienol for acute treatment of social anxiety disorder (SAD) is now projected to provide topline results in the first half of 2026.

The PALISADE-3 trial, part of the same program, is on schedule with its topline data expected in the fourth quarter of this year. Vistagen previously reported positive outcomes from its PALISADE-2 Phase 3 trial in 2023. Financial data from InvestingPro shows the company holds more cash than debt on its balance sheet, though it’s currently burning through cash at a significant rate. Track detailed clinical trial progress and financial metrics with InvestingPro’s comprehensive research tools. Both the ongoing PALISADE-3 and the forthcoming PALISADE-4 trials are designed to mirror the successful PALISADE-2 trial, with improvements in site training, surveillance, and subject selection aimed at replicating its positive results.

Shawn Singh, President and CEO of Vistagen, expressed optimism about the trials, citing strong patient and physician interest and the potential of fasedienol to address the increasing prevalence of SAD, which affects over 30 million adults in the U.S.

Fasedienol is an investigational intranasal therapy that aims to regulate fear and anxiety neurocircuits without systemic absorption or binding to neurons in the brain. Its novel mechanism of action distinguishes it from existing anxiety medications. The U.S. FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of SAD.

The PALISADE Phase 3 program includes the PALISADE-3 and PALISADE-4 trials and a small Phase 2 repeat dose study requested by the FDA to further understand fasedienol’s dose response and mechanism of action. Success in either the PALISADE-3 or PALISADE-4 trial, combined with the PALISADE-2 results, may provide substantial evidence of effectiveness to support a potential New Drug Application submission to the FDA for the acute treatment of SAD.

Vistagen is headquartered in South San Francisco, CA, and focuses on developing new intranasal therapies known as pherines for conditions such as social anxiety disorder, major depressive disorder, and women’s health issues. With analyst price targets ranging from $12 to $15 per share and a current trading price of $2.58, InvestingPro analysis suggests the stock may be undervalued. Discover more insights and detailed company analysis in InvestingPro’s exclusive Research Report, available for over 1,400 US stocks.

This update is based on a press release statement from Vistagen. The forward-looking statements in the press release are based on current expectations and involve risks and uncertainties, which could cause actual results to differ materially. The information provided does not guarantee the success of ongoing or future trials, regulatory approvals, or commercial viability of Vistagen’s product candidates.

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