PharmAla Biotech Signs Supply and Data Agreement with Aalborg University Hospital for Danish Randomized Trial of MDMA-Assisted Treatment for Service-Related PTSD
LaNeo™ to be the sole MDMA supply for the MIRROR study; PharmAla receives a perpetual, worldwide licence to the study
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TORONTO, Nov. 09, 2026 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTCQB: MDXXF), a biotechnology company focused on the research, development and manufacturing of MDXX-class molecules, including its proprietary LaNeo™ MDMA, announces that it has signed a Project Supply Agreement (the “Agreement”) with the North Denmark Region, acting through the Unit for Psychiatric Research at Aalborg University Hospital (“Aalborg University Hospital”).
Under the Agreement, PharmAla will be the sole supplier of MDMA for the MIRROR study: “A Randomized, Open-label, Rater-Blinded, Controlled Trial of Psychotherapy versus Music-Assisted Relaxation in MDMA-Facilitated Treatment for Service-Related PTSD.” Aalborg University Hospital is the study sponsor. The study will compare two forms of support given with MDMA: psychotherapy, and music-assisted relaxation.
Key terms
- Supply: PharmAla will supply LaNeo™ (MDMA HCl) 40 mg and 20 mg capsules, manufactured under Good Manufacturing Practice and released PharmAla’s European Union Qualified Person. Aalborg will pay a cash sum in addition to providing a license to its data.
- Data licence: Aalborg University Hospital will deliver an anonymized data package to PharmAla after database lock. This includes dosing and safety data, the final clinical study report and the hospital’s safety and efficacy analyses. PharmAla receives a non-exclusive, perpetual, irrevocable, worldwide, royalty-free licence to use this data, including for regulatory submissions and commercial purposes, with the right to sublicense to partners.
- Regulatory support: PharmAla will provide chemistry, manufacturing and controls information to support the hospital’s regulatory submissions for the study.
- Independence: Aalborg University Hospital will publish the study results, whether positive, negative or inconclusive. PharmAla has no influence on the study data or results.
“Most MDMA trials ask whether the drug works. MIRROR asks a different question: what kind of support works best with it. That question matters to every health system that wants to deliver MDMA-assisted treatment at scale,” said Nicholas Kadysh, Founding CEO, PharmAla Biotech. “We are proud that Aalborg University Hospital chose LaNeo™ MDMA for this work. This agreement also follows our supply-and-data model: we supply GMP drug, and we receive rights to high-quality clinical data that adds value to our regulatory and commercial programs in Europe and elsewhere in exchange for a discount.”
MDMA-assisted treatment for PTSD has shown promising results, but an important unanswered question is how much of the therapeutic effect depends on the accompanying psychotherapy. The MIRROR trial is designed to address this directly by comparing MDMA combined with psychotherapy with MDMA combined with a much less intensive therapeutic approach. Understanding the contribution of psychotherapy is important both scientifically and for determining how MDMA-based treatments might eventually be implemented in clinical practice,” said Professor René Ernst Nielsen, Aalborg University Hospital.
The Agreement adds to PharmAla’s growing base of clinical trial supply relationships with academic and government institutions, and extends the Company’s clinical supply footprint in the European Union.
Restora Neuroscience to Present at BIO-Europe
PharmAla Biotech CEO Nicholas Kadysh will be presenting data pertaining to the company’s APA-01 Novel Molecular Entity, as well as its wholly-owned Special Purpose Vehicle (SPV), Restora Neuroscience, at the BIO-Europe Conference on Monday, November 9th.
Restora’s participation in the conference is made possible with support from the Ministry of Economic Development, Job Creation and Trade of the Ontario Government. Restora was selected as a featured company by the Canadian Trade Commissioner Service.
Restora will also be participating in London Life Sciences Week, November 16-18.
About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) 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 as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. 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.
For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
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