Neuren Pharmaceuticals shares just hit a 12-month high. There could be more good news to come

I first came across Neuren Pharmaceuticals Ltd (ASX: NEU) about two and a half years ago, when a short seller took aim at its US partner and current sole source of revenue, Acadia Pharmaceuticals Inc (NASDAQ: ACAD).

The company, Culper Research, was trying to make the case that the launch of Daybue, a drug developed by Neuren to treat Rett Syndrome and licensed to Acadia, was "a total flop".

Neuren's shares came under a bit of pressure at the time, but fast forward to the present day, and the best revenge is to succeed in your endeavours, it seems, with demand for Daybue skyrocketing.

Revenue upgrades as sales soar

Neuren shares hit a 12-month high of $23.76 on Thursday, 5 November, after the company released an update about Daybue sales.

Kudos to the team at Bell Potter, which, back in June, tipped that the shares would hit $23.50 within 12 months.

I'll run through the Daybue results, but hang around to see what else the company is working on.

Faster than expected growth

Neuren said on Thursday that Daybue net sales were up 39% in the third quarter over the same period last year to US$140 million, with Acadia increasing full-year sales guidance from US$480 million to US$510 million to US$505 million to US$520 million.

Neuren's expected Daybue licensing earnings also increased, up from US$53 million to US$56 million to US$91 million to US$93 million.

The company also announced that Daybue was launched in Germany in October, earning Neuren a US$35 million milestone payment, while plans were on foot to have the drug approved for use in Japan.

Neuren Chief Executive Officer Jon Pilcher said of the results:

The Neuren team is excited about the impressive performance of Daybue in Q3 2026 and an outlook that continues to strengthen. 39% growth from Q3 2025 reflects strong momentum in the US and the recent launch in Germany marks the beginning of new growth beyond North America.  

While the Daybue results are undeniably strong, the company also has other irons in the fire.

Multiple treatments targeted by new drug candidate

It has an investigative drug candidate, NNZ-2591, which is being tested for its use in multiple ailments including Phelan-McDermid syndrome, Pitt Hopkins syndrome, and Angelman syndrome.

Just this week, the company received orphan drug designation for the compound's potential to treat neonatal hypoxic-ischemic encephalopathy (HIE), and it has orphan drug designation for the other maladies also.

Orphan Drug designation is a special status that the Food & Drug Administration can grant to a drug to treat a rare disease or condition with fewer than 200,000 patients in the United States.

Neuren is currently conducting a Phase 3 clinical trial evaluating the safety and efficacy of NNZ-2591 in children aged 3 to 12 years with Phelan-McDermid syndrome, as well as a 52-week open-label extension study.

Foolish Takeaway

Neuren is generating strong revenues with negligible debt on the books as at its last financial report.

With Daybue looking to go from strength to strength and other trials nearing completion it's an exciting time for the company.

The post Neuren Pharmaceuticals shares just hit a 12-month high. There could be more good news to come appeared first on The Motley Fool Australia.

Motley Fool contributor Cameron England has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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