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Company plans FDA meeting this quarter for new Phase 3 trial.
Vistagen Therapeutics, Inc. (Nasdaq: VTGN) announced preliminary positive data from an open-label extension of a Phase 3 trial for its drug candidate, Fasedienol, in treating social anxiety disorder. The data indicates that Fasedienol is well-tolerated up to 12 months. The company intends to meet with the FDA this quarter to discuss the initiation of a new Phase 3 trial.
The extension trial provided insights into the long-term tolerability of Fasedienol, a key factor for chronic treatment conditions. Vistagen's upcoming FDA meeting will focus on the design and parameters of the new Phase 3 trial, aiming to build on the positive preliminary results.
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