Cortexa Advances Commercialisation of MDMA Supply in Australia
Rhea-AI Summary
Cortexa (MDXXF) confirms commercial progress for MDMA supply in Australia, having committed the majority of its first GMP batch and securing supply arrangements with authorised providers. Sales value related to these activities will exceed AUD$1.0 million. PharmAla has begun producing a second GMP 20mg capsule batch expected to be available in Q2 2026. The three-year licence with annual $250,000 payments concludes in FY2026, while the joint venture retains rights including first refusal on PharmAla innovations and royalty provisions.
Positive
- Committed sales exceeding AUD$1.0 million from initial GMP batch
- Production started on a second GMP 20mg capsule batch, available Q2 2026
- Majority of first batch committed to clinical programs and patient treatment
Negative
- Previously contracted three-year licence with $250,000 annual payments concludes in FY2026, altering prior payment structure
- Ongoing dependency on PharmAla for manufacturing, IP access and royalty arrangements
News Market Reaction – MDXXF
On the day this news was published, MDXXF declined 3.69%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
MELBOURNE, Australia, March 23, 2026 (GLOBE NEWSWIRE) -- Cortexa (Cortexa or the Company), a leading psychedelic medicines supplier, reaffirms its market leading position in FY2026 for MDMA (3,4-methylenedioxymethamphetamine).
Cortexa is a 50/50 joint venture between PharmAla Biotech (CSE: MDMA) and Vitura Health (ASX: VIT). Following completion of the world’s largest (and first Australian) GMP batch of MDMA capsules earlier this financial year, the Company has secured supply arrangements with authorised providers nationally to support clinical programs and patient treatment under Australia’s regulated prescribing pathways.
Through Cortexa market activities, the majority of the initial batch has now been committed. The Cortexa sales value for these activities will exceed AUD
To support current and future requirements, PharmAla has initiated the production of a second GMP batch of a new 20mg dosage form (another Australian first), which is expected to be available to Cortexa’s customers in the second quarter of calendar year 2026.
“This week, PharmAla’s management team is meeting with Cortexa’s customers and partners across Australia,” said Nick Kadysh, founding CEO, PharmAla Biotech. “We’re incredibly excited to hear firsthand about the growth in the Australian market, and are exceptionally focused on bringing new innovation to Australia to support its continued rapid growth.”
Cortexa’s products are manufactured to support local clinical research and patient treatments by Authorised Psychiatrists under the Therapeutic Goods Administration’s (TGA’s) Authorised Prescriber Scheme. Since 1 July 2023, psychedelics have been available to be prescribed in Australia for the treatment of specific mental health conditions.
The company also confirms that the previously contracted three-year licence arrangement with PharmAla Biotech, which involved annual licence payments of
In parallel, developments in the Australian healthcare system continue to support the emerging psychedelic therapies sector, including reimbursement initiatives from organisations such as Medibank Private and treatment support programs through the Department of Veterans’ Affairs.
Mr. Kadysh also commented on Australia’s potential as a route to deliver new and innovative products to patients.
“Cortexa provides PharmAla with a dedicated sales organization and local expertise in the most exciting market for commercial MDMA-assisted therapies, and we’re excited to share the fruits of our development to expand this market even further in the coming months – starting with our 20mg GMP capsule, and moving on to even more exciting opportunities with our customers.”
Cortexa expects these developments to underpin the joint venture’s planned commercial growth outcomes for FY2026 and beyond.
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.
FAQ
What commercial agreements did Cortexa (MDXXF) announce on March 23, 2026?
When will Cortexa’s second GMP 20mg MDMA capsule be available for MDXXF customers?
How does the ending licence affect Cortexa (MDXXF) financial arrangements in FY2026?
What regulatory pathway does Cortexa (MDXXF) use to supply MDMA in Australia?
How will Cortexa (MDXXF) benefit from PharmAla’s future product development?
