Neurizon secures GMP supply of monepantel to strengthen NUZ 001 commercial readiness

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Neurizon Therapeutics (ASX:NUZ) has executed a long-term supply agreement with Elanco Animal Health that gives the company access to scalable Good Manufacturing Practice supply of monepantel, the active pharmaceutical ingredient in its lead asset NUZ‑001.

The initial five-year agreement builds on a prior global licence signed in July 2025 and is intended to support late-stage clinical development in the Phase 2/3 HEALEY ALS platform trial and to lay the commercial and manufacturing foundations should regulatory approval be achieved.

The arrangement sets out provisions for forecasting, production scheduling, supply, confidentiality, and termination. It details the first two supplies with rights to defer delivery pending regulatory approval, and is supported by a separate Quality Agreement that allocates GMP manufacturing, quality control, batch release and change management responsibilities.

Neurizon said the supply framework will be used to create a strategic inventory holding and to strengthen long-term supply certainty, regulatory CMC infrastructure and operational scalability as NUZ‑001 progresses.

The company highlighted the deal as a capital-efficient step that enhances the economic profile and strategic flexibility of the program as discussions continue with potential pharmaceutical partners and investors.

Interim Executive Chairman Sergio Duchini said, "This agreement represents a critical milestone in the continued advancement of the NUZ-001 program and furthers our relationship with Elanco. Importantly, the agreement strengthens Neurizon’s long-term manufacturing and supply framework, supporting potential future commercialisation and operational scalability following completion of the Phase 2/3 program. The agreement provides Neurizon with a long-term supply of monepantel for human use, reflecting a disciplined, risk-managed approach to capital management. Combined with our existing licence agreement, this supply arrangement further enhances the strategic and commercial foundation underpinning NUZ-001 and strengthens Neurizon’s positioning as a clinically advanced and commercially focused neurodegenerative disease company."