Latest European Medicines Agency News

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

Actinogen Medical has reached a pivotal agreement with the US FDA outlining the regulatory and clinical trial requirements for Xanamem’s approval in Alzheimer’s disease, setting a clear path toward a US marketing application.

Cambium Bio has secured a strategic partnership with French pharmaceutical leader Benta SAS to commercialise its regenerative dry eye treatment, Elate Ocular, across Europe and the Middle East. This follows a second platelet-lysate licensing deal within days, underscoring growing industry confidence in Cambium’s platform.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.

Neuren Pharmaceuticals reported a robust half-year with an 88% increase in net profit, driven by rising royalties from DAYBUE™ sales and progress in its NNZ-2591 clinical program. The company also completed a $39.6 million share buy-back, underscoring confidence in its growth trajectory.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

Avecho Biotechnology reports strong progress in its Phase III clinical trial for a CBD-based insomnia treatment, with recruitment accelerating across multiple Australian sites and interim results expected early next year.

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.

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.