Healthcare

PharmAla Completes GMP Manufacturing of Drug Substance components for ALA-002 Provides Corporate Update Regarding ALA-002 Asset

TORONTO, July 06, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), 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 ma

Pharmala Biotech Holdings, Inc.July 6, 20265 min read
PharmAla Completes GMP Manufacturing of Drug Substance components for ALA-002 Provides Corporate Update Regarding ALA-002 Asset

About this update from Pharmala Biotech Holdings, Inc.

TORONTO, July 06, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), 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. "This GMP manufacturing milestone represents not only an important step in PharmAla's development, but a key achievement for the development of the second generation of MDMA analogues," said Farnoud Kazemzadeh, COO, PharmAla Biotech. "PharmAla's management team has worked hard to ensure that ALA-002's development will accelerate in the coming months, with manufacturing of the drug substance being the 'starting gun'." PharmAla Granted Australian Patent for its lead candidate, ALA-002 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. The Australian grant is a meaningful milestone for PharmAla's regional strategy. Cortexa to Exercise Option to ALA-002 for the Australian MarketPursuant to the Joint Venture agreement executed between Pharmala Biotech Inc. and Vitura Health Ltd., Cortexa (the 50/50 joint venture owned by the two companies) has a Right of First Refusal to any new innovation developed by PharmAla. PharmAla is pleased to announce that 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. ...

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PharmAla Biotech Holdings Inc.GMPdrug substancePharmAla Biotech Holdings Incclinical activitiesdrug candidatemanufacturingAustralia