Item 8.01 Other Events.
On November 30, 2022, Vistagen Therapeutics, Inc. (the "Company") announced
receipt of a "Study May Proceed" letter from the U.S. Food and Drug
Administration ("FDA"). The letter greenlights a U.S. Phase 1 clinical trial
under the Company's newly filed Investigational New Drug ("IND") application for
clinical development of PH10 in the U.S. as a standalone treatment for major
depressive disorder ("MDD"). The small Phase 1 trial (n=12) will involve the
Company's newly optimized formulation of PH10 and is intended to both confirm
the favorable safety profile of PH10 established in three previous clinical
studies, including a published Phase 2A study for the treatment of MDD, and
facilitate the Company's plans for Phase 2B development of PH10 as a stand-alone
treatment for MDD. A copy of the press release is attached to this Current
Report on Form 8-K as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Index
Exhibit No. Description
99.1 Press Release issued by Vistagen
Therapeutics, Inc., dated November
30, 2022.
104 Cover Page Interactive Data File
(embedded within the Inline XBRL
document)
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