Latest Neuren Pharmaceuticals (Asx:Neu) News

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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.
Ada Torres
Ada Torres
22 Dec 2025
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.
Victor Sage
Victor Sage
15 Dec 2025
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.
Victor Sage
Victor Sage
6 Nov 2025
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.
Ada Torres
Ada Torres
20 Oct 2025
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.
Ada Torres
Ada Torres
27 Aug 2025
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.
Ada Torres
Ada Torres
25 Aug 2025
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.
Ada Torres
Ada Torres
8 Aug 2025
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.
Victor Sage
Victor Sage
7 Aug 2025
Neuren Pharmaceuticals has been granted a US patent for NNZ-2591 to treat Pitt Hopkins syndrome, bolstered by promising Phase 2 clinical trial results and FDA orphan drug status.
Ada Torres
Ada Torres
26 June 2025
Neuren Pharmaceuticals posted record 2024 financials driven by DAYBUE royalties and advanced NNZ-2591 into Phase 3 trials, while launching a $50 million share buy-back amid volatile market sentiment.
Ada Torres
Ada Torres
27 May 2025
Neuren Pharmaceuticals has approved a significant long-term equity incentive plan tied to critical clinical and regulatory milestones for its drug candidate NNZ-2591, reinforcing management’s commitment to shareholder value.
Ada Torres
Ada Torres
23 May 2025
Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.
Ada Torres
Ada Torres
13 May 2025