Jon Pilcher on Ausbiz: Neuren eyes global growth as DAYBUE sales impress

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Key points:

• Neuren Pharmaceuticals (ASX:NEU) achieves record quarterly sales for DAYBUE drug

• Significant growth opportunities identified in US community healthcare segment

• European and Japanese regulatory milestones could drive higher royalties and payments

• Investigational 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.