Regulatory2026-08-05

EB-003 (EVM301 series)

Enveric Biosciences Inc.ENVB
Indication
Mental health disorders
Stage
phase0
Event
Submission
Details

August 5, 2026: Enveric Biosciences (NASDAQ: ENVB) reported new preclinical data for EB-003, its lead neuroplastogenic candidate, showing results in a GloSensor cAMP assay that the company says support a non-hallucinogenic profile. EB-003 was tested against hallucinogenic and non-hallucinogenic reference compounds, and Enveric said it consistently fell within the non-hallucinogenic range. The company said these findings align with its previously reported BRET assay data and with published Nature research linking 5-HT2A receptor-mediated Gi signaling to hallucinogenic compounds.

The catalyst is a preclinical update as EB-003 advances toward first-in-human development. Enveric said the new assay results add complementary evidence supporting its development strategy and planned Phase 1 clinical development. Forward-looking statements also reference a planned IND submission and the goal of obtaining FDA clearance to initiate clinical trials.

The release also notes recent FDA final guidance on hallucinogenic psychedelic therapies; Enveric argues that if EB-003’s non-hallucinogenic profile is confirmed in humans, it could potentially support more conventional blinded trials and outpatient use, though this remains unproven pending clinical studies.