Announcement • Jul 07
PharmAla Biotech Holdings Inc. Completes GMP Manufacturing Of Drug Substance Components For ALA-002 And Provides Corporate Update Regarding ALA-002 Asset PharmAla Biotech Holdings Inc. announced the successful completion of GMP (Good Manufacturing Practice) manufacturing of drug substance necessary for the manufacturing of ALA-002. This milestone marks a significant step forward in the program’s development, providing sufficient material to support upcoming clinical activities. With drug substance manufacturing now complete, the Company is prepared to begin GMP manufacturing of the drug product, the formulated finished form that will be used in clinical activities globally. The successful scale-up and execution of the drug substance batch under GMP conditions demonstrate the maturity and reproducibility of the Company’s manufacturing process and underscore its readiness to advance ALA-002 toward the clinic. PharmAla has been granted an Australian patent, number 2022330718, entitled “Compositions Comprising Non-Racemic Mixtures of (R)- and (S)-3,4-Methylenedioxymethamphetamine or (R) and (S) N-Methyl-1,3-Benzodioxolylbutanamine and Uses Thereof” — the composition-of-matter foundation for its lead drug candidate, ALA-002. Cortexa (the 50/50 joint venture owned by PharmAla Biotech Inc. and Vitura Health Ltd.) has a Right of First Refusal to any new innovation developed by PharmAla. The board of Directors of Cortexa has voted to exercise its rights to commercialize the ALA-002 intellectual property. Cortexa’s option rights relate solely to the Australia territory. Subsequent to Cortexa’s decision to exercise its option for ALA-002, the ALA-002 Drug Product will be known in Australia as LaNeo Gen 2. PharmAla already owns, and sublicenses to Cortexa, the “LaNeo” branding in Australia. LaNeo stand for GMP manufacturing quality, reliability, and safety; LaNeo Gen 2 product represents that, and innovation to improve both Patient safety and Clinic Operator efficiency. Announcement • May 04
Pharmala Biotech Holdings Inc., Annual General Meeting, Jul 09, 2026 Pharmala Biotech Holdings Inc., Annual General Meeting, Jul 09, 2026. Announcement • Apr 24
Pharmala Biotech Holdings Inc. Announces Leadership Changes, Effective April 21, 2026 Pharmala Biotech Holdings Inc. announced that Ali Taghva will transition out of his role as Chief Commercial Officer to focus on other projects. Mr. Taghva will leave the role of Chief Commercial Officer effective April 21, 2026, and will fully transition out of the company by July 2026.