Latest European Medicines Agency News

Avecho Biotechnology has received $1.66 million from the Australian Government’s R&D Tax Incentive, reinforcing its commitment to a pivotal Phase III trial for its CBD-based insomnia treatment and accelerating its commercial ambitions.

Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.

Neurotech International has reported excellent safety and tolerability for its lead drug NTI164 in 28-day GLP toxicology studies, paving the way for regulatory submissions and longer-term clinical development.

Dimerix Limited has announced a US licensing transaction for its Phase 3 asset DMX-200 targeting FSGS, alongside progress updates on its clinical trial. The move underscores the company’s push to address a rare kidney disease with no approved therapies.

Neurizon Therapeutics reported a sharp rise in half-year losses to $7.28 million but marked significant progress with its lead drug NUZ-001 entering a major ALS clinical trial and securing critical regulatory designations.

CLINUVEL has released preliminary data from its CUV052 study showing SCENESSE® is well tolerated in adolescent erythropoietic protoporphyria (EPP) patients, supporting a planned label extension in 2025.

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.

Neurizon Therapeutics reports encouraging 8-month interim results for its ALS drug NUZ-001, secures Orphan Medicinal Product Designation in Europe, and raises $885,000 through a share placement, maintaining a robust $14 million cash position.