Company Advances Next-generation Patented MDMA Toward Patient Dosing in 2026
TORONTO, ON — April 20, 2026 — PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) ("PharmAla" or the "Company"), a global leader in the research, development and manufacturing of MDMA and next-generation MDXX class molecules, today responded to the Executive Order signed on April 18, 2026 by the President of the United States, which directs the U.S. Food and Drug Administration ("FDA") and the U.S. Drug Enforcement Administration ("DEA") to establish a pathway for eligible patients to access investigational psychedelic drugs, and directs the FDA Commissioner to issue National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designation.
Positioned and Ready to Supply the U.S. Expanded Access Pathway
PharmAla is fully positioned and operationally ready to supply the U.S. Expanded Access pathway contemplated by the Executive Order. PharmAla’s LaNeo™ MDMA is already present in the United States and is actively being supplied into several U.S. clinical trials, including trials sponsored by and conducted within the U.S. Department of Veterans Affairs (VA) and the U.S. Defense Health Agency (DHA). PharmAla’s supply chain, quality systems, and regulatory filings are in place to scale rapidly in response to any increase in U.S. demand generated by the Executive Order.
“The Executive Order signed this weekend marks an important inflection point for U.S. patients, and for our sector,” said Nicholas Kadysh, CEO of PharmAla Biotech. “This is the moment we built for. PharmAla has GMP MDMA in the United States today, active supply into VA and DHA programs, and the most successful commercial MDMA operation on the planet through our Australian joint venture. We're not preparing. We're ready.”
ALA-002 GMP Manufacturing Initiated; Patient Dosing Expected in 2026
PharmAla also confirmed today that it has initiated GMP manufacturing of its patented ALA-002 active pharmaceutical ingredient ("API"), the Company’s lead next-generation MDXX class drug candidate. Consistent with prior guidance, PharmAla continues to expect that ALA-002 will be dosed in patients in 2026. ALA-002 has been designed with an improved safety profile relative to MDMA — in particular, a materially reduced cardiovascular signature — and is the foundation of PharmAla’s next-generation therapeutic pipeline.
Cortexa Australia: The World’s Only Real Commercial MDMA Market
Through its Cortexa joint venture in Australia, PharmAla is the number one supplier of MDMA into the legal Australian clinical market — the only jurisdiction globally in which MDMA is currently approved for prescription by Authorised Prescriber psychiatrists for the treatment of PTSD. This operating footprint gives PharmAla exceptional and unique commercial insight into how a real-world commercial MDMA market actually behaves — insight that is not available to any other MDMA developer globally, and that is directly informing both PharmAla’s commercial strategy and the development profile of ALA-002 and other molecules.
Clinical Insight from Australia: Cardiotoxicity Is a Core Commercial Consideration
Dr. Farnoud Kazemzadeh, Chief Operating Officer of PharmAla Biotech, stated: “On a recent trip to Australia, I had the opportunity to spend time with our partner clinics and prescriber customers and hear directly from them about what is actually happening in the real world of commercial MDMA-assisted therapy. MDMA-related cardiovascular stress consistently came up as a real constraint on patient eligibility and clinic throughput. That's driving unprompted commercial interest in ALA-002, which was engineered to address exactly this limitation.”
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca