TAIRĀWHITI, New Zealand and TORONTO, Canada, October 8, 2026 (GLOBENEWSWIRE) -- Rua Bioscience Limited (NZX: RUA) (“Rua”) and PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) (“PharmAla”) announce that Rua and PharmAla Biotech Inc., a subsidiary of PharmAla, have signed a distribution and licence agreement. Under the agreement, Rua will import, distribute and sell PharmAla’s pharmaceutical-grade LaNeo™ MDMA in New Zealand.
The agreement follows Medsafe’s approval, on 4 September 2026, of two psychiatrists to prescribe pharmaceutical-grade MDMA for post-traumatic stress disorder (PTSD). This makes New Zealand only the second country, after Australia, to allow authorised psychiatrists to prescribe MDMA. Rua will supply PharmAla’s 40 mg LaNeo™ MDMA capsules, manufactured to good manufacturing practice (GMP) standards, to authorised prescribers in New Zealand. The first shipment will be supplied on a consignment basis, so Rua can enter the market with minimal upfront capital.
A natural extension of Rua’s business
Rua has built its business on the safe, compliant supply of controlled medicines. Its licensing, quality systems, regulatory expertise and prescriber relationships in medical cannabis apply directly to this new category. The agreement adds a second regulated medicine to Rua’s portfolio and opens a new revenue opportunity without significant additional investment, consistent with Rua’s capital-light strategy.
A GMP partner with an established supply record
PharmAla is one of the first companies in the world to manufacture GMP-grade MDMA. It supplies clinical trials and authorised prescribers internationally, including in Australia, where authorised psychiatrists have prescribed MDMA since 2023.
The rise of psychedelic medicine
Psychedelic medicine is moving from the margins into mainstream clinical practice. In 2023, Australia became the first country to allow authorised psychiatrists to prescribe MDMA and psilocybin. New Zealand followed with its first approval to prescribe psilocybin for treatment-resistant depression in 2025, and now MDMA for PTSD. For people whose conditions have not responded to conventional treatment, these medicines offer a carefully controlled new option, delivered under strict clinical supervision.
Paul Naske, Chief Executive Officer of Rua Bioscience, said: “Medical cannabis taught us that safe, regulated access to new medicines starts with small, careful steps. Medsafe’s decision on MDMA is one of those steps, and we’re proud to help make it real for patients. This agreement builds on what Rua already does well, adds a new product category to our business, and positions us early in a field we expect to grow as the evidence and the regulatory framework continue to develop.”
Nicholas Kadysh, Chief Executive Officer of PharmAla Biotech, said: “Medsafe’s decision gives New Zealand psychiatrists a path to treat PTSD with MDMA. Those clinicians need a reliable, GMP-grade supply. Rua has the licences, quality systems and prescriber relationships to deliver it from day one, and shares our regulatory-first approach. We are pleased to partner with them.”
Looking ahead
Rua will now work with PharmAla and Medsafe to complete the remaining regulatory and quality steps before the first shipment. Patient numbers will be modest at first, but both companies see this as an important first step in a broader shift in how Aotearoa approaches mental health treatment.
Termination of prior New Zealand distribution agreement
PharmAla also announces that, on September 1, 2026, PharmAla Biotech Inc. and JC Logistics Ltd t/a Veridion Group (“Veridion”) signed a termination and mutual release agreement. It ends, by mutual consent, the exclusive New Zealand distribution and license agreement between them dated September 21, 2025, which PharmAla announced on September 25, 2025. Veridion held no PharmAla inventory, purchase orders or regulatory registrations, and no amounts are payable by either party in connection with the termination. The termination allowed PharmAla to appoint Rua as its New Zealand distributor.
About Rua Bioscience
Rua Bioscience Limited (NZX: RUA) is a New Zealand company based in Tairāwhiti that supplies regulated medicines, beginning with medical cannabis.
For more information, please contact:
Paul Naske, Chief Executive Officer
paul.naske@ruabio.com
+64 21 445 154 | PO Box 1387, Gisborne 4040, Aotearoa New Zealand
www.ruabio.com
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