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Production / Operations

PharmAla Biotech Australia Contracts with UK-based CDMO for Manufacture of ALA-002 Drug Substance

By The Northwire Desk — AI Analysis Dec 15, 2025 · 08:30 MDMA · 0.11 Pharmala Biotech Holdings Inc.
MDMA · Price

Executive Summary

  • PharmAla Biotech Australia has secured a contract with a UK‑based CDMO to manufacture the drug substance for its novel MDMA formulation ALA‑002.
  • The partnership is a key prerequisite for launching the Phase 2a/2b clinical trial of ALA‑002 in 2026 targeting Social Anxiety Disorder.
  • The company completed one of two scheduled shipments of LaNeo™ MDMA to Mount Sinai’s Parsons Research Center for use in ongoing psychedelic‑healing research.

Key Details

  • Contract with UK CDMO:
  • Sub‑contract awarded to an undisclosed United Kingdom contract development and manufacturing organization (CDMO) for process development and bulk manufacture of ALA‑002 drug substance.

  • Execution follows a global RFP conducted by PharmAla Biotech Australia.

  • ALA‑002 Development Milestone:

  • First new active pharmaceutical ingredient (API) development since 2022.

  • Patent‑protected, non‑racemic MDMA formulation intended for Phase 2a/2b clinical trials in 2026.

  • Clinical Trial Timeline:

  • Planned initiation of Phase 2a/2b trial to evaluate ALA‑002 for Social Anxiety Disorder in 2026, contingent on successful manufacturing scale‑up.

  • Shipment to Mount Sinai:

  • Completed one of two contracted shipments of LaNeo™ MDMA to the Parsons Research Center at Mt. Sinai Hospital for clinical research purposes (originally announced Oct 21, 2024).

  • Forward‑Looking Statements:

  • The release contains forward‑looking information regarding manufacturing timelines, trial initiation, and regulatory expectations.

Notable Quotes

“PharmAla Australia worked diligently, executing a global RFP search to find our ideal partner for process development and manufacturing of the ALA‑002 drug product components,” – Nick Kadysh, Founding CEO, PharmAla Biotech.

“This is an important and necessary step to us executing our ALA‑002 Phase 2 clinical trial in 2026, and the first time since 2022 that PharmAla will be developing a wholly new Active Pharmaceutical Ingredient for human use.” – Nick Kadysh, Founding CEO, PharmAla Biotech.

Read the original news release →

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CSE: MDMA

Production / Operations