Latest European Launch News

Neuren has lifted its 2026 trofinetide income guidance to US$91 million-US$93 million after Acadia reported a 39% rise in Q3 DAYBUE sales and a US$35 million German launch milestone. Japan trial results also support a planned 2027 regulatory filing, although a launch remains subject to approval and a distribution partner.

Neuren Pharmaceuticals saw a record Q2 with DAYBUE net sales hitting US$125 million, driven by strong uptake of the new STIX formulation. The company upgraded its 2026 royalty guidance following Acadia Pharmaceuticals’ sales boost and awaits key regulatory milestones in Europe and Japan.

AFT Pharmaceuticals posted a 22% revenue jump to NZ$254.7 million and a 39% increase in operating profit to a record NZ$24.4 million for FY26, exceeding guidance. The company targets over NZ$300 million revenue for FY27, fueled by international expansion and a deepening R&D pipeline.

Acadia Pharmaceuticals has received a negative vote from the European Medicines Agency’s committee on its application to market trofinetide for Rett syndrome in the EU, prompting plans for a re-examination request.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

AVITA Medical reported a 13% drop in Q3 commercial revenue to $17.1 million but improved its net loss and secured CE Mark approval for RECELL GO in Europe, signaling strategic shifts ahead.

OncoSil Medical reports a remarkable 917% increase in quarterly cash receipts alongside promising clinical trial results and key European market entries, signaling robust momentum in its pancreatic cancer treatment rollout.

Memphasys secures a follow-up order for its Felix™ sperm selection cartridges from a leading Japanese fertility clinic, marking growing adoption in one of the world’s largest IVF markets and signaling a strategic shift to direct sales.

ECS Botanics reports a positive cash flow milestone in Q1 FY26, driven by strong direct-to-consumer sales and operational efficiencies, while preparing for a European market debut.

AVITA Medical has secured the CE Mark for its innovative RECELL GO device, paving the way for commercialization across key European markets including Germany, Italy, and the UK. This regulatory milestone expands the company’s footprint in acute wound care.

Neuren Pharmaceuticals reports a robust 11% rise in DAYBUE™ US net sales for Q1 2025, alongside a 17% jump in royalty income, setting the stage for an anticipated European market entry in early 2026.