OPERATING REVIEW CONTINUED 1 Acadia estimates 2 Reimbursement currently not recommended by CDA-AMC Approved Mar 2023 Oct 2024 Jan 2026 Approved Active NPP Approved2 Japan 1,000 - 2,000 Rett patients1 Orphan Drug Designation status granted Phase 3 results expected Q4 2026/Q1 2027, to facilitate marketing application in 2027 Europe 9,000 - 12,000 Rett patients1 Active named patient supply programs Plan to request CHMP reexamination, with potential outcome late Q2 2026 RoW Named patient supply programs in select countries Israel Canada 600 - 900 Rett patients1 US 6,000 - 9,000 Rett patients1 receipt of these grounds to re-examine its opinion, with new rapporteurs appointed for the re-examination. This means the CHMP opinion on the re-examination is likely to be at the end of Q2 2026. In the meantime, named patient supply programs are continuing. If granted marketing authorisation, trofinetide would be the first and only approved therapy for Rett syndrome in the European Union. In Japan trofinetide received Orphan Drug Designation and Acadia commenced a small clinical trial to support a marketing application, with results anticipated in Q4 2026 or Q1 2027, facilitating the application in 2027. DAYBUE oral solution was approved in Canada in October 2024 and in Israel in January 2026, although reimbursement of DAYBUE is currently not recommended by Canada’s Drug Agency (CDA-AMC). Further information about DAYBUE, including prescribing information can be accessed at www.DAYBUE.com LONG TERM GROWTH OPPORTUNITY FOR TROFINETIDE THROUGH GLOBAL EXPANSION There is urgent unmet need for a treatment for Rett syndrome around the world, evidenced by communications received from families, patient support groups and physicians. In January 2025, Acadia submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. In March 2026, Acadia was informed by the Committee for Medicinal Products for Human Use (CHMP) of the EMA of a negative opinion vote regarding the MAA. Acadia is requesting a re-examination of the opinion by the CHMP. Pursuant to EU legislation, an applicant has the right to request a re-examination of a CHMP opinion within 15 calendar days of receipt of the opinion, followed by submission of the grounds for the request for re-examination within 60 calendar days of receipt of the opinion. The CHMP has up to 60 days after Neuren Pharmaceuticals Limited Annual Report 2025 8
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