Q3 2026 DAYBUE net sales up 39%, full year guidance upgraded
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Neuren (NEU) – ASX Announcement 5 November 2026
Q3 2026 DAYBUE net sales up 39% from Q3 2025, full year guidance upgraded
Q3 Highlights:
• Neuren guidance for 2026 total income from trofinetide (including royalties and milestone
payments) increased to US$91 - 93 million from US$53 - 56 million
• US$35 million milestone payment earned on DAYBU® launch in Germany in October 2026
• Acadia increased full year 2026 global net sales guidance for trofinetide to US$505 - 520
million (from US$480 - 510 million), implying full year 2026 royalty income for Neuren of
US$56 - 58 million (previously US$53 - 56 million)
• Q3 2026 DAYBUE net sales of US$140 million, up 39% from Q3 2025, driven by strong uptake
of DAYBUE STIX
• Neuren earned Q3 2026 royalty income of US$16.4 million, up 51% from Q3 2025
• Japan trial results supportive of a planned regulatory submission in 2027; potential launch in
2028 subject to regulatory approval
References to DAYBUE net sales include all forms of trofinetide, unless otherwise stated
Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today reported highlights from the Q3 2026
financial results announcement and conference call of its partner, Acadia Pharmaceuticals (Nasdaq:
ACAD), both of which can be accessed in the Investors section of the Acadia website www.acadia.com.
Acadia reported Q3 2026 net sales of DAYBUE® of US$140 million, up 39% on Q3 2025 and up 12% on
Q2 2026. Acadia increased full year 2026 global net sales guidance for DAYBUE to US$505 - 520 million
(from US$480 - 510 million).
Q3 sales growth was driven by strong uptake of DAYBUE STIX by existing patients as well as new patient
starts and patient restarts. More than 50% of US DAYBUE users are already on DAYBUE STIX, up from
40% at the end of Q2. During Q3 a new US patent was allowed, which covers weight-banded dosing of
trofinetide, extending US patent protections for DAYBUE and DAYBUE STIX by nearly five years, through
March 2041.
In Europe, DAYBU was launched in Germany in October 2026, with patients already receiving treatment.
The first commercial sale earned Neuren a milestone payment of US$35 million. Under the licence
agreement, for Europe (including all European Union member states as of 13 July 2023 plus the United
Kingdom, Iceland, Norway, Switzerland and Liechtenstein), Neuren is also entitled to receive sales
milestone payments and tiered royalties summarised in the table below.
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Tiered Royalty Rates (% of Net Sales)1
Sales Milestones2
Annual Net Sales Rates Net Sales in one calendar year US$m
≤ US$150m 17% ≥ US$120m US$15m
> US$150m, ≤ US$300m 20% ≥ US$240m US$30m
> US$300m 23% ≥ US$400m US$50m
≥ US$600m US$75m
1. Royalty rates payable on the portion of annual net sales that fall within the applicable range
2. Each sales milestone payment is payable once only
Acadia has completed the Phase 3 study of trofinetide in Rett syndrome in Japan, with results consistent
with the LAVENDER Phase 3 study and supportive of a planned regulatory filing. Acadia continues to
pursue a distribution partner in preparation for regulatory filing in 2027 and a potential launch in 2028,
subject to regulatory approval.
Neuren CEO Jon Pilcher commented: “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. We are pleased to be able to upgrade our guidance for Neuren’s 2026 total
income from trofinetide to US$91 - 93 million.”
In Q3 2026 Neuren earned royalties of US$16.4 million, up 51% on Q3 2025. Anticipated royalties for
the full year 2026 increased to a range of US$56 million to US$58 million, from the previous range of
US$53 million to US$56 million. Including the US$35 million first commercial sale milestone payment in
Europe, Neuren’s total income from trofinetide in 2026 is expected to be in the range of US$91 million
to US$93 million.
* Full year estimates based on Acadia full year 2026 DAYBUE Net Sales Guidance of US$505-520m
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Click here to view this announcement on our Investor Hub.
About Neuren
Neuren Pharmaceuticals is developing new drug therapies to treat multiple serious neurological
disorders caused by genetic abnormalities or brain injury, that have no or limited approved treatment
options. Neuren’s therapies target the critical role of Insulin-like growth factor 1 (IGF-1) in the brain,
using orally administered analogs of naturally occurring peptides.
DAYBUE® (trofinetide) oral solution and DAYBUE STIX (trofinetide) powder are approved for the
treatment of Rett syndrome by the US Food and Drug Administration (FDA). The oral solution is also
approved by the European Medicines Agency, Health Canada and the Ministry of Health in Israel.
Neuren has granted an exclusive worldwide license to Acadia Pharmaceuticals Inc. for the development
and commercialisation of trofinetide.
Neuren’s investigative drug candidate, NNZ-2591 (ercanetide), is in clinical development as an oral
solution treatment for multiple neurodevelopmental disorders, including Phelan-McDermid syndrome,
Pitt Hopkins syndrome and Angelman syndrome. Each of these programs has been granted “orphan
drug” designation in the United States and the European Union as well as Fast Track and Rare Pediatric
Disease designations from the FDA. NNZ-2591 has also been granted orphan drug designation for the
treatment of hypoxic ischemic encephalopathy (HIE), a serious condition caused by brain injury before or
shortly after birth.
Currently, Neuren is conducting a Phase 3, randomized, double-blind, placebo-controlled clinical trial
(“Koala”) evaluating the safety and efficacy of NNZ-2591 in children aged 3 to 12 years with Phelan-
McDermid syndrome and a 52-week open-label extension study.
https://neurenpharma.com/link/PmEzMP
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Investor contact:
Jon Pilcher, CEO & Managing Director
+61 438 422 271
investorrelations@neurenpharma.com
Media Contact:
Monsoon Communications
Rudi Michelson
rudim@monsoon.com.au
ASX Listing Rules information
This announcement was authorized to be given to the ASX by the Board of Neuren Pharmaceuticals
Limited, Suite 1.01, 117 Camberwell Road, Hawthorn East, VIC 3123
Forward-looking Statements
This announcement contains forward-looking statements that are subject to risks and uncertainties. Such
statements involve known and unknown risks and important factors that may cause the actual results,
performance or achievements of Neuren to be materially different from the statements in this
announcement.
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