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0.262881390179834 0.182056981208325 0.0606183067286321 -0.0489997979389777 -0.040210143463326 -0.0721357850070722 -0.0301070923418873 -0.00990099009900993
Stock impact report

Enveric Biosciences Receives FDA Response and Streamlines Plans for EB-003 IND Submission

Enveric Biosciences, Inc. (ENVB) 
Company Research Source: Business Wire
Enveric expects to file Investigational New Drug application for EB-003 in early 2026 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) to its request for a Pre-Investigational New Drug (pre-IND) Type B meeting for its lead program, EB-003.In its response, the FDA indicated that the questions for the pre-IND meeting proposed by Enveric were a matter for IND application review and FDA recommends that Enveric proceed to submitting its IND application and protocol for review. Enveric interprets this outcome as consistent with the view that the Company is sufficiently advanced in its development strategy to proceed past the pre-IND meeting milestone.As a result, Enveric will streamline its regulatory p Show less Read more
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