Company Interview / Neuren eyes global growth as DAYBUE sales impress

Key points:

Neuren Pharmaceuticals (ASX:NEU) achieves record quarterly sales for DAYBUE drugSignificant growth opportunities identified in US community healthcare segmentEuropean and Japanese regulatory milestones could drive higher royalties and paymentsInvestigational drug NZ2591 targets broader neurodevelopmental indications with ongoing phase three trial

Neuren Pharmaceuticals (ASX:NEU) has achieved significant milestones in the third quarter, as Jon Pilcher highlights a record-breaking quarter for its DAYBUE medication, with sales exceeding $100 million USD and more than 1,000 active Rett syndrome patients on the drug. The company notes an 11% year-on-year sales growth and a 5% increase quarter-on-quarter. Pilcher identifies strong performance outside US centres of excellence, with 74% of new prescriptions coming from community neurologists—an area with substantial future potential and currently around 29% penetration.

Pilcher states that the company’s US growth is supplemented by global ambitions, with key regulatory milestones expected in Europe and Japan. A decision on Neuren’s European marketing application is anticipated in the first quarter of 2026, carrying a $35 million USD milestone payment upon approval. Royalties in these regions could surpass those in the US, potentially compensating for smaller sales volumes and sustaining long-term global growth.

Looking ahead, Pilcher expresses optimism for the investigational drug NZ2591, aimed at broader indications including Phelan-McDermid syndrome. The phase three “koala trial” underway in the US marks a significant step in Neuren's pipeline. Pilcher sees significant upside, viewing the company’s volatility as possible opportunities for investors.