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Production / Operations

Cortexa Advances Commercialisation of MDMA Supply in Australia

By The Northwire Desk — AI Analysis Mar 23, 2026 · 09:00 MDMA · 0.1 Pharmala Biotech Holdings Inc.
MDMA · Price

Executive Summary

  • Cortexa (50/50 JV between PharmAla Biotech and Vitura Health) reaffirmed its market‑leading position in FY2026 for MDMA, with sales from the first GMP batch projected to exceed AUD 1.0 million.
  • A second Australian‑first 20 mg GMP batch is being produced by PharmAla and is expected to be available in Q2 2026.
  • The three‑year licence agreement between Cortexa and PharmAla (annual payments of $250,000) will conclude in FY2026, with ongoing royalty rights and a right of first refusal on future innovations.

Key Details

  • First GMP Batch: Completed the world’s largest (and first Australian) GMP batch of MDMA capsules; majority of this initial batch already committed to customers.
  • Sales Value: Cortexa expects sales from the first batch to exceed AUD 1.0 million.
  • Second GMP Batch: PharmAla has initiated production of a new 20 mg dosage form (Australian first); target availability Q2 2026 for Cortexa customers.
  • Licence Arrangement: The existing three‑year licence with annual payments of $250,000 ends in FY2026; the JV retains access to manufacturing processes and IP, plus a right of first refusal on new PharmAla innovations.
  • Royalty Provisions: PharmAla will continue to receive royalties under the Joint Venture Agreement for future product developments.
  • Regulatory Context: MDMA therapies have been prescribable in Australia since 1 July 2023 under the TGA’s Authorised Prescriber Scheme; ongoing reimbursement initiatives from Medibank Private and the Department of Veterans’ Affairs support market growth.

Notable Quotes

“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.” – Nick Kadysh, Founding CEO, PharmAla Biotech

“Cortexa provides PharmAla with a dedicated sales organization and local expertise in the most exciting market for commercial MDMA‑assisted therapies… starting with our 20 mg GMP capsule, and moving on to even more exciting opportunities.” – Nick Kadysh, Founding CEO, PharmAla Biotech

Read the original news release →

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CSE: MDMA

Production / Operations