Latest Manufacturing Milestones News

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.

Carnegie Clean Energy marked steady progress in Q3 2025, hitting key manufacturing milestones for its CETO wave energy system in Spain, securing €4 million in EU funding, and raising $2.1 million from shareholders to fuel commercialisation efforts.

Li-S Energy has marked a milestone with the production of Australia’s first lithium metal foils and expanded its footprint in the global defense sector, supported by new manufacturing capabilities and strategic partnerships.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug NUZ-001, alongside a $5.2 million capital raise and a key licensing deal with Elanco Animal Health. These developments position the company for a critical growth phase in neurodegenerative disease therapeutics.

Imagion Biosystems has made significant strides toward filing an IND application for its MagSense® HER2 breast cancer imaging agent, supported by positive FDA feedback and a recent $3.5 million capital raise to fund upcoming clinical trials.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent, progressing toward a Phase 2 clinical trial with strong collaborations and a recent AU$3.5 million capital raise.

Neurizon Therapeutics has raised $5 million through an institutional placement to advance its lead ALS drug candidate NUZ-001 into a pivotal clinical trial, pending FDA clearance. The capital injection also supports manufacturing and pre-clinical development efforts.

Tetratherix Limited reported a $9.4 million statutory loss for FY25 amid significant R&D and operational investments, successfully listing on the ASX and progressing multiple clinical and manufacturing initiatives.

LTR Pharma has initiated commercial distribution of its nasal spray SPONTAN through Australia's Symbion pharmacy network and is advancing ROXUS development for a US launch in early 2026, while expanding its pipeline with a new intranasal treatment for swallowing disorders.

InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.