Latest Neuren Pharmaceuticals (ASX:NEU) News

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.

Neuren Pharmaceuticals has published promising Phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, underpinning its ongoing Phase 3 Koala trial recruiting in the US.

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.

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.

Neuren Pharmaceuticals reported a milestone quarter with DAYBUE net sales reaching US$101.1 million, driving a 24% jump in royalty income. The expanding patient base and community physician uptake signal strong growth ahead.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

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.

Neuren Pharmaceuticals has initiated the first US investigational site for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, marking a significant milestone in addressing this rare neurodevelopmental disorder.

Neuren Pharmaceuticals has added SYNGAP1-related disorder to its NNZ-2591 development program following encouraging pre-clinical findings, targeting a rare condition with no approved treatments.

Neuren Pharmaceuticals reports a 16% rise in Q2 2025 royalties driven by Acadia’s DAYBUE sales growth and expanding patient base in the US. Full-year sales guidance remains strong with European market entry on the horizon.