Enveric Biosciences (ENVB) said Tuesday that it will streamline its regulatory pathway and proceed to an Investigational New Drug, or IND, application, for its depression and anxiety treatment candidate, EB-003.
The company said it expects to file the IND application in early 2026.
Enveric said that in response to its Pre-Investigational New Drug Type B meeting request to the FDA, the regulator indicated that the company's queries were a matter for review under an IND application and recommended that it proceed with the submission.
Shares of the company were up 1.1% in recent Tuesday premarket activity.