September 16, 2025 — Leads & Copy — Enveric Biosciences (NASDAQ: ENVB) will proceed to submit its Investigational New Drug (IND) application for EB-003, its lead neuroplastogen, after receiving feedback from the FDA regarding its pre-IND meeting request.
The FDA indicated that Enveric’s questions were more appropriate for IND application review. Enveric views this as an affirmation of their development strategy, enabling them to streamline the regulatory path for EB-003, which is designed to address depression and anxiety without hallucinogenic effects.
Dr. Joseph Tucker, CEO of Enveric Biosciences, expressed encouragement, stating the IND submission is a key milestone for the company. Enveric’s pipeline is supported by a patent estate including 26 issued U.S. patents and 60 pending applications.
About Enveric Biosciences: Enveric Biosciences is focused on developing next-generation, small-molecule neuroplastogenic therapeutics for psychiatric and neurological disorders. Their lead candidate, EB-003, targets both 5-HT₂A and 5-HT₁B receptors.
For more information contact:
Investor Relations:
ir@enveric.com
Source: Enveric Biosciences
