Neuren (ASX:NEU) Reports AUD 15m Half-Year Profit and Expands NNZ-2591 Development Pipeline

Sonal Goyal

27 August 2025 11:52 AM AEST

Neuren (ASX:NEU) Reports AUD 15m Half-Year Profit and Expands NNZ-2591 Development Pipeline

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Neuren reported H1 2025 profit after tax of AUD 15.0 million, up from AUD 8.0 million in H1 2024.

Royalty income from DAYBUE® increased to AUD 28.3 million, supported by Acadia’s H1 US sales of USD 180.7 million.

Neuren advanced its NNZ-2591 pipeline, initiating a Phase 3 trial in PMS, securing FDA Fast Track for PTHS, and adding new indications including HIE and SRD.

Neuren Pharmaceuticals Limited (ASX:NEU) has announced its half-year financial results for the six months ended 30 June 2025 (H1 2025), reporting profit after tax of AUD 15.0 million, up from AUD 8.0 million in the prior corresponding period. The increase was primarily driven by continued growth in royalty income from DAYBUE® (trofinetide), which rose to AUD 28.3 million compared with AUD 24.3 million in H1 2024.

DAYBUE, marketed in the United States by Acadia Pharmaceuticals (Nasdaq:ACAD) for the treatment of Rett syndrome, recorded US net sales of USD 180.7 million during H1 2025, up from USD 160.5 million in the prior period. Acadia has issued full-year 2025 guidance for DAYBUE US net sales in the range of USD 380 million to USD 405 million, implying royalty income for Neuren of AUD 62–67 million, compared with AUD 56 million received in 2024.

Outside the United States, Acadia has submitted a Marketing Authorisation Application for trofinetide in the European Union, with potential approval expected in Q1 2026. To support early access, named patient supply programs have been initiated in Europe through Clinigen, in Israel through Rafa, and across other international markets through Farmamondo. Two-thirds of diagnosed Rett patients in the US are yet to commence treatment with DAYBUE, offering further opportunity for uptake.

Neuren completed a AUD 50 million share buyback during the half, executed at an average price of AUD 12.27 per share. The company closed the period with AUD 300 million in cash and short-term investments, compared with AUD 222 million at 31 December 2024. Basic earnings per share increased to 11.9 cents, up from 6.3 cents in H1 2024.

The company continues to progress development of its second drug candidate, NNZ-2591, across multiple indications. During the half, the US Food and Drug Administration (FDA) agreed to primary endpoints for a single pivotal Phase 3 trial in Phelan-McDermid syndrome (PMS), and Neuren initiated its first investigational site in the United States. This will be the first Phase 3 trial conducted in PMS, a serious neurodevelopmental disorder without approved therapies.

In addition, NNZ-2591 in Pitt Hopkins syndrome (PTHS) received Fast Track designation from the FDA, alongside allowance of a US patent extending protection until 2040. Development was also initiated in Hypoxic Ischemic Encephalopathy (HIE), a major cause of neonatal death and disability, while SYNGAP1 related disorder (SRD) was added to the pipeline following encouraging pre-clinical data.

With its pipeline expansion supported by a robust cash position, Neuren has signalled continued investment in advancing therapies for rare and serious neurological conditions while maintaining strong financial momentum from DAYBUE royalties.

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