CAMBRIDGE, Mass.– Enveric Biosciences (NASDAQ: ENVB), a biotechnology company developing next-generation neuroplastogenic small molecules for psychiatric and neurological disorders, announced today that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its request for a Pre-Investigational New Drug (pre-IND) Type B meeting for its lead program, EB-003.
In its reply, the FDA stated that Enveric’s proposed pre-IND questions fall under the scope of an IND application review and recommended the company proceed directly to submitting its IND application and clinical protocol. Enveric interprets this feedback as an indication that its development plans are sufficiently advanced to move forward without a pre-IND meeting.
As a result, the company will streamline its regulatory process and advance toward filing an IND application for EB-003, which it expects to submit in early 2026.
“We are encouraged by the FDA’s response, which enables us to focus our efforts on advancing EB-003 into clinical development,” said Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences. “The IND submission for EB-003 is an inflection point for Enveric, and we believe we are well positioned to execute efficiently on our clinical strategy and continue building value across our pipeline.”
EB-003, Enveric’s lead neuroplastogen, is designed as a dual-acting compound with potential to treat depression and anxiety by promoting durable neuroplastic changes without hallucinogenic effects. The company’s pipeline is supported by a broad intellectual property portfolio, including 26 issued U.S. patents and 60 pending national and international applications covering multiple differentiated molecules.
