Key Takeaways
- PharmAla Biotech has completed its first batch of Australian-made LaNeo™ MDMA 40mg capsules.
- The company has delivered its product to the Orygen Institute for a Phase 3 trial on social anxiety in autistic youth.
- Plans for 2026 include producing 20mg capsules and the first run of ALA-002 capsules.
Production Progress
PharmAla Biotech Holdings Inc. has announced the successful completion of testing for its initial batch of LaNeo™ MDMA 40mg capsules, produced in Australia. COO Farnoud Kazemzadeh remarked on the significance of this milestone, which represents a collaborative effort with Cortexa to bolster PharmAla’s operations in the Australian market and beyond.
The announcement comes with the completion of the first shipment of Australian-made MDMA capsules to the Orygen Institute. This shipment is particularly important as it concludes PharmAla’s contract with Orygen, which has utilized the product in its Phase 3 trial focused on social anxiety among autistic youth.
PharmAla aims to enhance its production capabilities significantly in 2026. Upcoming initiatives include the development and release of LaNeo™ 20mg capsules, alongside the encapsulation of ALA-002, PharmAla’s lead drug candidate. The company emphasizes its commitment to alleviating the global shortage of clinical-grade MDMA while also working on novel drug development within the MDXX class.
As a “regulatory first” organization, PharmAla prioritizes strong relationships with regulatory bodies, reflecting its understanding that progress in the psychedelics sector relies on sustainable collaboration. This approach sets PharmAla apart as it strives to be the leading supplier of clinical-grade MDMA outside clinical trials.
For further inquiries, PharmAla invites stakeholders to reach out to their Chief Executive Officer, Nicholas Kadysh, via email or phone.
Please note: This press release includes forward-looking statements which may be affected by various risks and uncertainties, and PharmAla does not commit to updating any such statements in the future.
The content above is a summary. For more details, see the source article.