2026-08-14 · trading-venues
Vistagen Reports Narrower Q1 Loss; Plans FDA Meeting On Fasedienol Development Path
(RTTNews) - Vistagen Therapeutics Inc. (VTGN), a late clinical-stage biopharmaceutical company developing intranasal pherine therapies for neuropsychiatric and other disorders, reported first quarter fiscal 2027 results and provided a corporate update.
Vistagen is developing rapid-onset intranasal pherine product candidates designed to target nose-to-brain neurocircuitry. Its lead programs include fasedienol for social anxiety disorder, itruvone for major depressive disorder and refisolone for menopausal hot flashes.
For the first quarter ended June 30, 2026, net loss narrowed to $13.0 million or $0.30 per share from $15.1 million or $0.47 per share in the year-ago quarter.
Revenue was $1.2 million, primarily related to the expiration of the exclusivity period under the company's agreement with Fuji Pharma.
Research and development expenses decreased to $10.9 million from $11.7 million a year ago, while general and administrative expenses declined to $3.9 million from $4.4 million.
Exploratory analyses from PALISADE-4 and the Phase 2 repeat-dose study showed nominally statistically significant improvement with fasedienol in patients with very severe social anxiety disorder.
Fasedienol was generally well tolerated, with more than 1,500 subjects receiving at least one dose, including more than 300 subjects with at least six months of exposure.
The company is preparing to engage with the FDA during the current quarter regarding a potential future Phase 3 registration-directed development pathway for fasedienol.
Vistagen received an FDA "Study May Proceed" letter for refisolone under its U.S. IND for the treatment of moderate-to-severe menopausal vasomotor symptoms.
The company also appointed Angel S. Angelov, M.D., MBA, as Chief Medical Officer and Douglas J. Williamson, M.D., to its Board of Directors.
Cash, cash equivalents and marketable securities totaled $31.7 million as of June 30, 2026.
Based on current operating plans, Vistagen expects its cash resources to fund operations into 2027, but not for more than one year from now.
Currently, VTGN is trading at $0.26, down 2.14%.
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