Enveric Biosciences Gets FDA Response On Request For Pre-IND Type B Meeting For Lead Program EB-003

(RTTNews) - Biotechnology company Enveric Biosciences, Inc. (ENVB) announced Tuesday 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 path by advancing toward the submission of its IND application for EB-003. The Company views this transition as in alignment with its development strategy providing a clear path forward to clinical evaluation.

EB-003 is Enveric's lead neuroplastogen, designed as a dual-acting compound with the potential to address depression and anxiety by promoting durable neuroplastic changes without hallucinogenic effects.