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Production / Operations

PharmAla Signs Supply & Data Agreement with Nautilus Sanctuary for Phase 2 MDMA Clinical Trial Treating Post-Traumatic Stress and Adjustment Disorder in Frontline Healthcare Workers and First Responders

By The Northwire Desk — AI Analysis Mar 03, 2026 · 09:00 MDMA · 0.095 Pharmala Biotech Holdings Inc.
MDMA · Price

Executive Summary

  • PharmAla Biotech executed a Supply & Data Agreement with Nautilus Sanctuary to provide LaNeo™ MDMA for a Phase 2 open‑label trial targeting PTSD in frontline healthcare workers and first responders.
  • In exchange, PharmAla receives a perpetual, non‑exclusive license to the de‑identified clinical trial data, which can be used for regulatory filings and commercial purposes worldwide.
  • The company also completed shipment of LaNeo™ MDMA to University College London for an earlier announced clinical trial, underscoring its role as a primary supplier of clinical‑grade MDMA.

Key Details

  • Agreement Parties: PharmAla Biotech Holdings Inc. (CSE: MDMA) and Nautilus Sanctuary Inc., Brooklyn, NY.
  • Product Supplied: LaNeo™ MDMA (clinical‑grade MDMA).
  • Trial Description: Open‑label Phase 2 study – “An Open Label Study to Treat Post‑Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA‑Assisted Therapy.”
  • License Granted to PharmAla: Perpetual, non‑exclusive right to use the Clinical Trial Data (pseudonymized, de‑identified raw data sets and analysis of safety/efficacy) for regulatory approvals and any commercial purpose in all jurisdictions.
  • Strategic Rationale: Supply‑for‑data model creates value by securing proprietary clinical evidence without cash outlay; supports PharmAla’s pipeline and potential future commercialization of LaNeo™ MDMA.
  • Additional Shipment: Completed delivery of LaNeo™ MDMA to University College London (UCL) for a previously announced clinical trial, reinforcing supply chain capabilities.
  • Quotes:
  • “This agreement represents a continuation of our innovative supply‑for‑data model… the clinical data generated … will be an important addition to our growing portfolio of clinical evidence supporting the safety and efficacy of LaNeo™ MDMA.” – Nicholas Kadysh, CEO, PharmAla Biotech.

Notable Quotes

  • “We deeply appreciate PharmAla’s donation of LaNeo MDMA to our study… Their generosity helps accelerate important clinical research…” – Dr. Willa Hall, President, Nautilus Sanctuary.
Read the original news release →

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Production / Operations