Enveric Biosciences Inc (NASDAQ:ENVB) reported that it has commenced genotoxicity testing for EB-003, its lead neuroplastogen drug candidate. The company said the announcement was followed by a 2.7% rise in its shares during premarket trading on Tuesday.
The firm described the studies as designed to determine whether EB-003 has the potential to interact with DNA and induce genetic mutations. Enveric emphasized that these safety evaluations are a critical element required before an Investigational New Drug, or IND, submission can be made.
According to the company, the testing program will be conducted under Good Laboratory Practice standards and will follow the International Council for Harmonisation S2(R1) guidelines. The planned battery includes established assays such as the Bacterial Reverse Mutation Assay - commonly called the Ames Test - along with the Micronucleus Assay.
Enveric characterizes EB-003 as its lead neuroplastogen candidate. The company develops neuroplastogenic small-molecule therapeutics aimed at treating psychiatric and neurological disorders, and it said the genotoxicity work represents a formal step in the candidate's preclinical safety program.
Joseph Tucker, chief executive officer of Enveric Biosciences, described the start of the genotoxicity studies as a milestone in EB-003's development. Tucker also pointed to a recent Executive Order signed by the President on April 18, 2026, saying that the order has the potential to accelerate research in the psychedelic and neuroplastogen space.
The company added that the preclinical program is intended to establish the safety profile necessary to move EB-003 toward first-in-human Phase 1 clinical trials. Enveric did not provide results from the assays, only that the tests have been initiated under GLP conditions and in alignment with ICH S2(R1) guidance.
Context and next steps
- Enveric will complete standard genotoxicity assays as part of its IND-enabling safety work.
- Successful completion and acceptable safety findings would be prerequisites to filing for and obtaining approval to begin Phase 1 human trials.
- The company's announcement coincided with a modest premarket share gain, reflecting investor attention to the development progress.
The announcement leaves open the timeline for when study results will be available or when a formal IND submission will be filed. Enveric's note that the studies are GLP-compliant and follow ICH S2(R1) guidelines indicates the company intends to meet recognized regulatory standards as it advances EB-003 through preclinical stages.