VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company committed to developing and commercializing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (“CNS”) disorders, released its financial and operating report for first quarter 2021, the period ended June 30, 2021. Highlights of the report include that the company’s PALISADE phase 3 program to evaluate PH94B for rapid-onset acute treatment of anxiety in adults with social anxiety disorder (“SAD”) is progressing on plan, and VistaGen alsoreceived approval from the U.S. Food and Drug Administration to proceed with its planned exploratory phase 2A clinical study of PH94B in adults experiencing adjustment disorder with anxiety (“AjDA”). Regarding financial numbers, the release noted that the company realized $0.4 million in sublicense revenue in Q2. That revenue resulted from VistaGen’s $5 million upfront payment related to its PH94B development and commercialization agreement with EverInsight Therapeutics, now AffaMed Therapeutics, during the quarter, compared to none in the same quarter last year. “The strong momentum we generated in fiscal 2021 leading up to the launch of our PALISADE phase 3 program for PH94B as a potential rapid-onset acute treatment of anxiety in adults with social anxiety disorder continued throughout the first quarter of fiscal 2022,” said VistaGen CEO Shawn Singh in the press release. “The initiation of PALISADE-1 was a major milestone in the program. That study is proceeding as planned, with topline data anticipated in mid-2022. We remain on track to initiate PALISADE-2, which will be a counterpart of PALISADE-1, later this year, together with several other planned clinical studies we believe will be supportive of a potential U.S. New Drug Application for PH94B if our PALISADE phase 3 program is successful. We have also made progress in our Phase 2A clinical development program for PH94B, which is focused on additional anxiety disorders beyond SAD. We recently received from the U.S. Food and Drug Administration notice that we may proceed with our proposed exploratory Phase 2A clinical study of PH94B for treatment of adjustment disorder with anxiety. We expect to initiate that study in the U.S. before year end.”
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About VistaGen Therapeutics Inc.
VistaGen Therapeutics is a biopharmaceutical company committed to developing and commercializing innovative medicines with the potential to go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen’s drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date and has therapeutic potential in multiple CNS markets. For more information about the company, please visit www.VistaGen.com.
NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN
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