When AbbVie reportedly agreed to acquire Gilgamesh Pharmaceuticals in a deal valued at over $1 billion, it sent a clear signal to the market: big pharma is betting on psychedelics. The acquisition validated the growing interest in compounds designed to treat psychiatric disorders by promoting neuroplasticity. It also underscored a crucial shift in the field, from hallucinogenic “first-wave” psychedelics like psilocybin and MDMA toward second-generation, scalable, and more clinically practical molecules.

First-Wave Psychedelics: Breakthroughs with Limits

Psilocybin and MDMA have produced some of the most promising late-stage clinical trial results in decades, showing dramatic improvements in treatment-resistant depression and PTSD. Yet, these therapies come with built-in challenges:

  • 6–8 hour clinic sessions with trained therapists.
  • High costs that complicate payer reimbursement.
  • Functional unblinding concerns flagged by the FDA.
  • Dependency on psychotherapy protocols that slow scalability.

These roadblocks, while not diminishing their scientific significance, raise questions about whether hallucinogenic psychedelics can truly integrate into mainstream mental health care.

Enveric’s Differentiated Approach

This is where Enveric Biosciences (NASDAQ: ENVB) comes in. Rather than attempting to optimize hallucinogenic compounds, Enveric is pioneering a new class of molecules it calls neurostabilogens, designed to capture the therapeutic benefits of psychedelics without triggering hallucinations.

Its lead candidate, EB-003, is a dual-acting 5-HT₂A/5-HT₁B partial agonist derived from DMT. Preclinical models have shown EB-003 can reduce anxiety and depression behaviors while remaining orally bioavailable and non-hallucinogenic. That profile positions EB-003 as a therapy that could be delivered in routine outpatient settings, expanding access while reducing costs and clinical burden.

FDA Progress: A Clearer Path to Clinical Trials

In September 2025, Enveric announced that it had received a written response from the FDA to its Pre-IND meeting request. Rather than requiring a detailed pre-IND review, the agency recommended that Enveric proceed directly to filing its IND application and protocol. Enveric interpreted this as validation that its program was advanced enough to move forward, streamlining its regulatory pathway.

The company now expects to submit its IND for EB-003 in early 2026, a major inflection point as it transitions from preclinical to clinical-stage development.

“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, CEO 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.”

Market Positioning: Following the Big Pharma Signal

  • AbbVie / Gilgamesh: Billion-dollar bet on next-gen psychedelics; strong validation of the field.
  • COMPASS Pathways (NASDAQ: CMPS): Psilocybin pioneer; efficacy proven but resource-heavy model.
  • MindMed (NASDAQ: MNMD): Developing LSD derivatives; still tied to hallucinatory effects.
  • MAPS PBC: MDMA-assisted therapy for PTSD; awaiting FDA decision, but therapy-dependent.
  • Enveric (NASDAQ: ENVB): Non-hallucinogenic neurostabilogens, streamlined FDA path, targeting scalable outpatient treatment.

The Road Ahead

With its FDA feedback in hand and an IND submission on the horizon, Enveric is positioning itself as a frontrunner in the next wave of psychedelic-inspired therapeutics. The company’s approach directly addresses the clinical, economic, and regulatory barriers that first-wave psychedelics face—potentially making neuroplasticity-inducing drugs accessible to far more patients.

As AbbVie’s billion-dollar move shows, the race to define the future of psychedelic medicine is on. Enveric’s EB-003 may well represent the practical, scalable solution that brings these therapies from research labs into everyday psychiatric care.