Neuren Technologies on Monday raised its full-year royalty guidance for DAYBUE, its lead therapy for Rett syndrome, to USD 53 million–56 million from prior expectations, citing updated sales forecasts from partner Acadia Pharmaceuticals.
The Melbourne-based biotech also declared an interim dividend of AUD 0.15 per share, fully franked, payable on October 7, 2024, marking a payout of approximately 90% of its available dividend pool of AUD 48 million–51.6 million. Neuren reported AUD 287 million in cash at June 30, eliminating the need for near-term capital raises.
DAYBUE, the first FDA-approved treatment for Rett syndrome, generated USD 23.1 million in royalty income during the first half of 2026, according to the company’s earnings call transcript. Acadia has upgraded its global sales guidance for DAYBUE to AUD 480 million–510 million for the year, up from prior ranges, with North American sales expected to exceed USD 500 million in a calendar year triggering a USD 50 million milestone payment to Neuren.
European commercialization plans accelerated following a June reversal of a negative CHMP opinion and subsequent European Commission approval. Acadia intends to launch DAYBUE in Germany in early Q4 2024. The DAYBUE STIX formulation reached 40% adoption among patients by June 30.
Neuren also outlined progress on NNZ-2591, its pipeline asset targeting Phelan-McDermid syndrome and Pitt-Hopkins syndrome. Program costs to the next development agreement are guided at USD 80 million–90 million. A U.S. FDA Type B meeting is scheduled for October, followed by a patient-focused drug development meeting in November. The company’s HIE program remains on track, with an IND filing now expected in the first half of 2025 following FDA feedback on a juvenile animal toxicity study.
The KOALA Phase III trial in Phelan-McDermid syndrome has enrolled patients across 15 U.S. and Canadian sites, with top-line results guidance to be provided once enrollment reaches approximately 50%. Neuren’s cash position and strong royalty pipeline supported a 49% return over the past six months, with shares last trading at AUD 22.695, a 0.73% gain.
The company’s available franking credits total approximately AUD 76 million, and corporate costs for H1 2026 were AUD 3 million, while interest income reached AUD 5.6 million. R&D spending rose to AUD 27.4 million due to the progression of the KOALA trial.
