drugset / Press release

DAYBUE net sales projected to reach approx US$700m in 2028

2026-01-13 · Neuren Pharmaceuticals Limited · original neurenpharma.com ↗

1 of 2 Neuren (NEU) – ASX Announcement 14 January 2026 DAYBUE® global net sales projected to reach ~US$700m in 2028 DAYBUE Highlights from Acadia presentation at J.P. Morgan Healthcare Conference: • Global DAYBUE net sales projected to reach ~US$700m in 2028 • Continued momentum with more than 2,000 Rett patients treated by DAYBUE since US launch and 12 months persistency increased to 55% • DAYBUE STIX formulation US launch commencing in Q1 2026 with full launch by Q2 2026 • DAYBUE oral solution approved by Ministry of Health in Israel • Top-line data from Phase 3 trial of trofinetide in Japan expected Q4 2026 / Q1 2027 Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the presentation and discussion by its partner Acadia Pharmaceuticals (Nasdaq: ACAD) at the 44th annual J.P. Morgan Healthcare Conference. Acadia projected DAYBUE global net sales to reach ~US$700m in 2028, with growth driven by: 1. Rollout of DAYBUE STIX (approved by US FDA in December 2025) that could potentially enable patient growth from families who had declined to try or discontinued the liquid formulation 2. Continued benefits from Q2 2025 expansion of US customer-facing teams 3. International expansion, assuming approval in Europe (CHMP opinion anticipated Q1 2026) Since DAYBUE’s launch in the US in 2023, more than 2,000 Rett syndrome patients have been treated by DAYBUE. Persistency at 12 months has now increased to 55%. Over 300 patients are participating in Acadia’s real-world LOTUS study which continues to develop and publish data. There are now approximately 6,000 diagnosed Rett syndrome patients in the US, increased from the previously 385 177 348 400 700 CY2023 (Apr -Dec) CY2024 CY2025 Acadia Guidance 2028 projected by Acadia DAYBUE Global Net Sales US$m 2 of 2 estimated range of 5,500 – 5,800, and up approximately 30% since launch. DAYBUE STIX powder formulation is now rolling out on a limited basis with full availability by beginning of Q2 2026 Outside the US, Acadia announced the approval of DAYBUE oral solution by the Ministry of Health in Israel. The Phase 3 clinical trial of trofinetide in Japan is ongoing with top-line results expected between Q4 2026 and Q1 2027. Acadia’s presentation can be accessed in the Investors section of the Acadia website www.acadia.com. About Neuren Neuren is developing new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options. DAYBUE® (trofinetide) and DAYBUE STIX (trofinetide) are approved by the US Food and Drug Administration (FDA) for the treatment of Rett syndrome. Neuren has granted an exclusive worldwide licence to Acadia Pharmaceuticals Inc. for the development and commercialisation of trofinetide. Neuren’s second drug candidate, NNZ-2591, is in development for multiple neurodevelopmental disorders, with positive results achieved in Phase 2 clinical trials in Phelan-McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Recognising the urgent unmet need, each program has been granted “orphan drug” designation in the United States and the European Union. Orphan drug designation provides incentives to encourage development of therapies for rare and serious diseases. Contact: [email protected] Jon Pilcher, CEO: +61 438 422 271 ASX Listing Rules information This announcement was authorized to be given to the ASX by the CEO & Managing Director of Neuren Pharmaceuticals Limited, Suite 1.01, 117 Camberwell Road, Hawthorn East, VIC 3123 Forward-looking Statements This announcement contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Neuren to be materially different from the statements in this announcement.

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