NEUREN PHARMACEUTICALS LIMITED

NEUREN PHARMACEUTICALS LIMITED (ASX: NEU)

Acadia's exclusive license for trofinetide expanded worldwide
Neuren to receive $100 million upfront, potential milestone payments up to $427 million, and royalties
Acadia expects net sales of $21-23 million in Q2 2023 and $45-55 million in Q3 2023 for DAYBUE in the US

2023-07-14 08:22:00

Neuren Pharmaceuticals has completed enrolment for its Phase 2 clinical trial of NNZ-2591 in Phelan-McDermid syndrome, with top-line results expected in December 2023.
Phase 2 clinical trials of NNZ-2591 for three other neurodevelopmental disorders are also underway, with results expected in 2024. All four programs have received Orphan Drug designation from the FDA.
The aim of the Phase 2 trial is to expedite the generation of data for a registration trial while preparing for Phase 3 development.

2023-06-30 09:36:00

Neuren Pharmaceuticals has opened the first site in the United States for its Phase 2 clinical trial of NNZ- 2591 in Prader-Willi syndrome, aiming to generate necessary data for designing a subsequent registration trial.
Alongside this, Phase 2 trials of NNZ-2591 are also undergoing for three other neurodevelopmental disorders – Phelan-McDermid, Pitt Hopkins and Angelman syndromes, each of which has received orphan drug designation from the FDA.
The open-label Phase 2 trial will examine safety, tolerability, pharmacokinetics and efficacy with NNZ-2591 in up to 20 children aged 4 to 12 years over 13 weeks, with the dosage escalated up to the target dose subject to safety review, and a final follow-up assessment conducted two weeks after the end of treatment.

2023-06-28 09:55:00

Neuren Pharmaceuticals receives a US$40 million milestone payment following the first commercial sale of DAYBUE™ (trofinetide) by their North America partner Acadia Pharmaceuticals.
DAYBUE was approved by the US FDA for the treatment of Rett syndrome, making it the first and only FDA-approved treatment for the condition.
Neuren is eligible for ongoing royalties on net sales of trofinetide in North America, milestone payments, and a one-third share of the Rare Pediatric Disease Priority Review Voucher's market value.

2023-06-07 15:19:00

DAYBUE™ (trofinetide) is now available in the US for the treatment of Rett syndrome in adult and pediatric patients aged two years and older, with Neuren earning US$40m from the launch.
Neuren is eligible to receive ongoing royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350m and one-third of the market value of the Rare Pediatric Disease Priority Review Voucher.
Neuren is also conducting Phase 2 trials for NNZ-2591, targeting Phelan-McDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome, and Prader-Willi syndrome, with all programs granted "orphan drug" designation in the US.

2023-04-18 09:50:00

Neuren's partner, Acadia Pharmaceuticals, receives FDA approval for DAYBUE (trofinetide).
DAYBUE is the first and only approved treatment for Rett syndrome.
Neuren will receive royalties and milestone payments on sales of DAYBUE.

2023-03-13 09:10:00