Enveric Biosciences, a biotechnology company developing next-generation neuroplastogenic small molecules for the treatment of psychiatric and neurological disorders, announced it has received a written response from the U.S. Food and Drug Administration (FDA) to its Pre-Investigational New Drug (pre-IND) Type B meeting request regarding its lead development candidate, EB-003.

In the communication, the FDA advised that the questions posed by Enveric are best addressed during the formal Investigational New Drug (IND) application review process. This guidance effectively signals that the Company is sufficiently advanced in its development efforts to proceed directly to IND submission without the need for a pre-IND meeting.

In response, Enveric will streamline its regulatory strategy by advancing directly toward IND submission for EB-003, which is anticipated in early 2026. This milestone marks a significant step forward in the Company's clinical development plans.

“We are encouraged by the FDA’s response, which supports our belief that our development strategy is on the right track,” said Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences. “This feedback enables us to focus our resources on progressing EB-003 into clinical evaluation. The planned IND submission represents a major inflection point for the Company, and we are confident in our ability to execute effectively and continue building value across our pipeline.”

EB-003 is Enveric’s lead neuroplastogen and has been designed as a dual-acting compound with the potential to treat depression and anxiety by promoting durable neuroplastic changes—without inducing hallucinogenic effects. The compound represents a novel approach in mental health treatment, addressing significant unmet needs in the psychiatric space.

Enveric’s innovation is supported by a robust intellectual property portfolio, which includes 26 issued U.S. patents and 60 pending national and international applications, covering a diverse set of differentiated molecules and therapeutic approaches.