Neuren Pharmaceuticals (ASX:NEU) has filed its activity and cash flow report for the fourth quarter of 2023.
CEO Jon Pilcher said, “In Q4 NNZ-2591 successfully passed a key value inflection point with strongly positive Phase 2 trial results in Phelan-McDermid syndrome. In parallel, our revenues from DAYBUE continue to grow following the very successful US launch by Acadia. Neuren closed Q4 with cash of A$229 million, in a very strong position to capitalise on the opportunities ahead of us.”
On 17 April 2023, Neuren’s US partner Acadia Pharmaceuticals launched DAYBUE as the first approved treatment for Rett syndrome. Net sales grew to US$66.9 million in the third quarter of 2023 and Acadia has provided guidance for net sales of US$80-87.5 million in the fourth quarter.
Neuren receives royalties as a percentage of net sales, currently 10 per cent. For the third quarter, it earned royalties of A$10.4 million, received in the fourth quarter. If Acadia achieves its guidance, Neuren said royalties of approximately A$12.1-13.2 million are anticipated for the fourth quarter.
At the J.P. Morgan Healthcare Conference in January 2024, Acadia provided a further update on activities for DAYBUE in key markets outside the US. Acadia anticipates a New Drug Submission filing in Canada in the first quarter of 2024 and potential approval around year-end 2024.
For Europe, Acadia is engaging with the European Medicines Agency, with a potential Marketing Authorisation Application filing in the first half of 2025. For Japan, Acadia is engaging the regulatory agency in 2024.
Neuren is also developing NNZ-2591 for four serious neurodevelopmental disorders that emerge in early childhood and have no or limited approved treatment options.
It said positive top-line results were announced in late 2023 from the Phase 2 clinical trial in Phelan-McDermid syndrome, and Phase 2 clinical trials are currently ongoing in children with each of Pitt Hopkins, Angelman and Prader-Willi syndrome.