Latest Neurological Disorders News

Neuren Pharmaceuticals has secured Health Canada approval to expand its pivotal Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome into Canadian sites, complementing ongoing US enrolment.

Neurotech International has locked in $4 million through a share placement to advance its promising paediatric neurological drug, NTI164. The raise, supported by both new and existing investors including company directors, aims to fund critical clinical and regulatory milestones.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.

Neurotech International has received a $4.73 million R&D tax incentive refund, reinforcing its clinical development efforts in paediatric neurological disorders. The funds will support ongoing trials and working capital needs.

Invex Therapeutics has appointed two new non-executive directors and joint company secretaries, signaling a refreshed governance structure alongside a change of company address.

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

Actinogen Medical has received approval for an additional $1.87 million research and development tax rebate, bringing its total FY25 rebate to $7.36 million. This funding underpins ongoing clinical trials of its Alzheimer’s and depression therapy candidate, Xanamem.

Neurotech International has secured a key FDA designation for its lead drug NTI164, advancing its potential to treat Rett syndrome with regulatory and financial benefits.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.

Argenica Therapeutics reported a 34% revenue increase driven by R&D incentives but saw losses widen by 31% due to intensified clinical trial activity. The company is progressing its ARG-007 Phase 2 stroke trial and engaging with the FDA to lift a clinical hold.

Clinuvel Pharmaceuticals reports steady financial growth with an 8% rise in revenue and 2% profit increase, while expanding its US commercial footprint and completing recruitment for a pivotal vitiligo trial.

Argent BioPharma has achieved a significant milestone by commencing formal supply of its EU-GMP cannabinoid API for epilepsy treatment at a leading Slovenian hospital and gaining prescription approval for CannEpil™ in Germany, marking key steps in its European expansion.