Enveric Biosciences, Inc (NASDAQ:ENVB) stock is trading higher on Friday after the U.S. Food and Drug Administration (FDA) accelerated action on psychedelics as treatments.
The FDA on Friday outlined a set of regulatory steps aimed at accelerating the development of serotonin-2A agonists and related psychedelic-based therapies, signaling a more proactive stance toward addressing mental health disorders.
The steps follow the White House directive released last week.
FDA Prioritizes Psychedelic-Based Treatments
Robert F. Kennedy Jr., Secretary of Health and Human Services, said the initiative aligns with broader efforts to fast-track promising treatments.
He emphasized prioritizing therapies that have received Breakthrough Therapy designation, particularly those showing early signs of significant improvement over existing options.
The effort, he added, focuses on conditions affecting veterans.
The agency announced it will issue national priority vouchers to three companies currently studying psychedelic compounds.
These include psilocybin for treatment-resistant depression and major depressive disorder, as well as methylone for post-traumatic stress disorder.
First U.S. Trial Cleared For Ibogaine Derivative
The FDA also allowed an early-stage clinical trial of noribogaine hydrochloride to proceed following an Investigational New Drug submission. The compound is being evaluated as a potential treatment for alcohol use disorder, a condition marked by high relapse rates and limited effective therapies.
The update marks the first time the FDA has permitted a U.S.-based clinical study involving a derivative of ibogaine, a psychoactive compound derived from the Tabernanthe iboga plant.
The sponsor, DemeRx NB, is expected to initiate a Phase 1 study under controlled clinical conditions.
Guidance Framework Expected Soon
The FDA clarified that allowing the trial to proceed does not indicate approval or confirmation of safety and efficacy. Ongoing data review will determine the next steps.
The agency also plans to release final guidance for sponsors developing these therapies. The framework will address challenges unique to psychedelic drug trials, including study design, patient monitoring, and data collection, aiming to standardize clinical evaluation in this emerging field.
Post the update, COMPASS Pathways Plc (NASDAQ:CMPS) stock jumped 5%, while Enveric Biosciences stock surged around 30%.
In February, COMPASS Pathways’ COMP360 synthetic psilocybin treatment for treatment-resistant depression showed a statistically significant reduction in symptom severity.
ENVB Stock Price Activity: Enveric Biosciences shares were up 29.85% at $5.22 at the time of publication on Friday, according to Benzinga Pro data.
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