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About Neuren (ASX:NEU)
Neuren Pharmaceuticals Limited is an ASX-listed biopharmaceutical company headquartered in Melbourne. Its revenue comes principally from royalties and milestone payments on trofinetide, the first drug approved for Rett syndrome, which is commercialised worldwide by Acadia Pharmaceuticals under an exclusive licence. Neuren retains its own candidate NNZ-2591, which is in clinical development for several neurodevelopmental disorders.
Neuren (ASX:NEU) Pharmaceuticals reported highlights from the Q2 2026 financial results announcement and conference call of its partner, Acadia Pharmaceuticals. Acadia announced Q2 2026 net sales of DAYBUE (trofinetide) of US$125 million, up 30% on Q2 2025 and 24% on Q1 2026, which Neuren said is the highest quarterly sales since launch. Neuren said the growth was almost entirely volume-driven, with adoption of DAYBUE STIX, the powder formulation broadly available in the United States from early April, exceeding expectations; 40% of all US DAYBUE patients were receiving STIX by quarter end and approximately 45% of STIX demand in the quarter came from new or returning patients. Neuren earned royalty income of US$12.9 million in Q2 2026, up 34% on Q2 2025 and 24% on Q1 2026. Acadia increased its full-year 2026 DAYBUE net sales guidance to US$480-510 million from US$460-490 million, which Neuren said implies full-year 2026 royalty income for Neuren of US$53-56 million, up from a previous range of US$50-54 million. Acadia reaffirmed a target of US$700 million of DAYBUE net sales in 2028.
In Europe, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion at the end of June 2026, following a re-examination procedure, recommending that the European Commission grant a marketing authorisation for trofinetide for the treatment of neurobehavioral symptoms of Rett syndrome in adults and paediatric patients aged five years and older. Neuren said that if approved the authorisation would apply to all 27 EU member states as well as Iceland, Liechtenstein and Norway, with commercial launch in Germany anticipated in early Q4 2026 pending the European Commission approval decision. Under the licence agreement for Europe, Neuren is entitled to receive US$35 million following first commercial sale, sales milestone payments of up to US$170 million on achievement of escalating annual net sales thresholds, and tiered royalties from mid-teens to low-20s percent of net sales. In Japan, topline results of the ongoing trofinetide clinical trial remain on track for the September to November 2026 timeframe, with a regulatory submission anticipated in 2027.
Source: Neuren Pharmaceuticals Limited (ASX:NEU), 5 August 2026. Summary content supplied by Digifin Pty Ltd.
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