| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Acadia reports DAYBUE net sales for 2025 and 2026 guidance
|
26 Feb 2026 11:15AM |
$12.710 |
$12.790 |
risen by
0.63%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Acadia reported full year 2025 DAYBUE net sales of US$391 million, up 12% year-on-year.
- Q4 2025 DAYBUE net sales reached US$110 million, a 13% increase compared to Q4 2024.
- Neuren’s full year 2025 royalty income was A$65 million, a 15% increase from 2024.
- Acadia’s guidance for full year 2026 DAYBUE net sales is US$460 million to US$490 million.
- Neuren expects full year 2026 royalty income of A$70 million to A$77 million from DAYBUE.
- DAYBUE STIX powder formulation was approved in December 2025, with a full launch expected by Q2 2026.
- Phase 3 clinical trial of trofinetide ongoing in Japan with results expected between Q4 2026 and Q1 2027.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Pause in Trading
|
26 Feb 2026 9:53AM |
$12.710 |
$12.790 |
risen by
0.63%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Neuren Pharmaceuticals Limited is listed with the security code NEU.
- A trading pause was announced for Neuren Pharmaceuticals Limited's securities.
- Further announcements from the company are anticipated.
- The announcement was made in compliance with ASX listings.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Update - Notification of buy-back - NEU
|
13 Feb 2026 9:32AM |
$13.570 |
$12.790 |
fallen by
5.75%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Notification of buy-back - NEU
|
11 Feb 2026 6:24PM |
$13.430 |
$12.790 |
fallen by
4.77%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Notification of Neuren investor webinar on 12 February 2026
|
11 Feb 2026 5:05PM |
$13.430 |
$12.790 |
fallen by
4.77%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Neuren to commence new on-market share buy-back program
|
11 Feb 2026 5:00PM |
$13.430 |
$12.790 |
fallen by
4.77%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Neuren Pharmaceuticals Limited announced a new on-market share buy-back program.
- Shares purchased under the buy-back will be cancelled, reducing the number of shares on issue.
- The buy-back limit will adhere to the '10/12' rule under the Australian Corporations Act, not requiring shareholder approval.
- Neuren is developing therapies for serious neurological disorders.
- The company’s drugs, DAYBUE® and DAYBUE STIX, are FDA approved for Rett syndrome.
- Neuren's drug candidate, NNZ-2591, is in Phase 3 trials for Phelan-McDermid syndrome.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
First patient dosed in Neuren PMS Phase 3 trial
|
6 Feb 2026 9:26AM |
$13.200 |
$12.790 |
fallen by
3.11%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- First Phase 3 trial for Phelan-McDermid syndrome.
- Trial involves drug NNZ-2591.
- Randomized, double-blind, placebo-controlled study.
- Involves 160 children aged 3 to 12 years.
- Has FDA's Fast Track, Rare Pediatric Disease, and Orphan Drug designations.
- Strong community interest with 25 families referred and more on waitlists.
- Two sites activated, 20 more progressing in the US.
- Neuren is the Presenting Sponsor of the 2026 Phelan-McDermid Syndrome Foundation Family Conference.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Priority Review Voucher program reauthorized by US Congress
|
5 Feb 2026 8:11AM |
$14.630 |
$12.790 |
fallen by
12.58%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Neuren receives US FDA meeting feeback for HIE and PTHS
|
4 Feb 2026 5:07PM |
$14.630 |
$12.790 |
fallen by
12.58%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Neuren received FDA feedback for NNZ-2591 development.
- Feedback provided as Written Responses Only and delayed.
- Clear path forward with minimal financial impact.
- For HIE, FDA accepted the clinical study plan but requested additional juvenile animal study data.
- For PTHS, FDA suggested using a PTHS-specific CGI scale with a functional outcome measure.
- Neuren plans to initiate the next trial in 2026.
- Progress in ongoing Koala Phase 3 trial for Phelan-McDermid syndrome.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Trading Halt
|
4 Feb 2026 10:14AM |
$14.630 |
$12.790 |
fallen by
12.58%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Neuren Pharmaceuticals Limited requested a trading halt starting 4 February 2026.
- The halt is in anticipation of an announcement concerning US FDA feedback on NNZ-2591.
- NNZ-2591 is being evaluated for Pitt Hopkins syndrome and Hypoxic-ischemic encephalopathy (HIE).
- The trading halt will lift by 6 February 2026 or upon the announcement.
- Neuren aims to manage disclosure obligations and ensure orderly market conditions.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Pause in Trading
|
4 Feb 2026 9:57AM |
$14.630 |
$12.790 |
fallen by
12.58%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Neuren Pharmaceuticals Limited has initiated a trading pause on ASX.
- The securities are traded under the code NEU.
- The pause is pending a future announcement.
- The action is a compliance measure by ASX Listings.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Acadia provides update on EU regulatory submission
|
3 Feb 2026 9:40AM |
$16.250 |
$12.790 |
fallen by
21.29%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Acadia Pharmaceuticals received a negative trend vote on trofinetide from CHMP.
- Acadia plans to request a re-examination of the CHMP opinion.
- Trofinetide is already approved in the US, Canada, and Israel.
- More than 1,000 patients are on active treatment with trofinetide globally.
- Neuren Pharmaceuticals supports the re-examination request.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Response to ASX Aware Letter
|
19 Jan 2026 9:10AM |
$19.140 |
$12.790 |
fallen by
33.18%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- NEU's announcement projected DAYBUE's global net sales to reach ~US$700m in 2028.
- The announcement led to a share price increase from $19.61 to $21.04.
- NEU confirmed the projection's material effect on securities' value.
- The projection's reasonableness was supported by ACAD's disclosures and NEU's internal models.
- NEU ensured compliance with ASX Listing Rules and confirmed immediate disclosure.
- NEU's Board authorized responses in line with continuous disclosure policy.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
DAYBUE net sales projected to reach approx US$700m in 2028
|
14 Jan 2026 10:26AM |
$19.930 |
$12.790 |
fallen by
35.83%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- DAYBUE global net sales projected to reach ~US$700m in 2028
- More than 2,000 Rett patients treated since US launch in 2023
- DAYBUE STIX US launch in Q1 2026, full launch by Q2 2026
- DAYBUE oral solution approved in Israel
- Phase 3 trial of trofinetide in Japan with results expected Q4 2026/Q1 2027
- Neuren's focus on therapies for serious neurological disorders
- Exclusive worldwide license granted to Acadia for trofinetide
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
NNZ-2591 PMS Phase 2 trial published in Neurology Genetics
|
7 Jan 2026 10:20AM |
$18.990 |
$12.790 |
fallen by
32.65%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Health Canada approves Clinical Trial Application for Koala
|
22 Dec 2025 9:48AM |
$19.590 |
$12.790 |
fallen by
34.71%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
FDA approves DAYBUE STIX (trofinetide), powder formulation
|
15 Dec 2025 9:05AM |
$19.010 |
$12.790 |
fallen by
32.72%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- FDA approved DAYBUE STIX, a new powder formulation of trofinetide.
- DAYBUE STIX is designed for Rett syndrome patients aged two years and older.
- The new formulation offers flexible dosing options by mixing with liquids.
- Neuren Pharmaceuticals will receive royalties from the sales.
- Approval was based on bioequivalence with the original DAYBUE oral solution.
- DAYBUE STIX expected to be available in early 2026.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
One-month administrative delay to FDA meeting for HIE
|
9 Dec 2025 10:38AM |
$19.940 |
$12.790 |
fallen by
35.86%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Application for quotation of securities - NEU
|
24 Nov 2025 5:43PM |
$18.380 |
$12.790 |
fallen by
30.41%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Investor Presentation, 10 November 2025
|
10 Nov 2025 8:46AM |
$18.580 |
$12.790 |
fallen by
31.16%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Record DAYBUE net sales of US$101.1 million in Q3 2025
|
6 Nov 2025 9:59AM |
$20.230 |
$12.790 |
fallen by
36.78%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Record DAYBUE™ net sales of US$101.1 million in Q3 2025.
- 11% sales increase from Q3 2024 and 5% from Q2 2025.
- Over 1,000 patients received shipments for the first time.
- 74% of new patient prescriptions from community physicians.
- Neuren earned A$16.4 million in Q3 2025 royalty income.
- Anticipated full year royalty income of A$63 – 66 million in 2025.
- Expanded market presence includes named patient programs and trials in Europe, Israel, Middle East, and Latin America.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Fast Track granted by FDA for NNZ-2591 in Phelan-McDermid
|
20 Oct 2025 9:28AM |
$20.650 |
$12.790 |
fallen by
38.06%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- FDA granted Fast Track for NNZ-2591 in Phelan-McDermid syndrome.
- Fast Track facilitates drug development and review for serious conditions.
- No FDA-approved treatments currently exist for Phelan-McDermid syndrome.
- The Koala trial is the first Phase 3 trial for this syndrome.
- Neuren is supporting awareness and diagnosis initiatives for the syndrome.
- Fast Track for NNZ-2591 also granted for Angelman syndrome.
- Eligible for Accelerated Approval and Priority Review under Fast Track.
- Phelan-McDermid syndrome caused by changes in chromosome 22 involving the SHANK3 gene.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should
refer to the full announcement here for further information.
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Change of registered office in Australia
|
17 Oct 2025 4:44PM |
$20.650 |
$12.790 |
fallen by
38.06%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Application for quotation of securities - NEU
|
3 Oct 2025 4:58PM |
$21.500 |
$12.790 |
fallen by
40.51%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$1,618 |
Notification regarding unquoted securities - NEU
|
22 Sep 2025 7:30AM |
$19.820 |
$12.790 |
fallen by
35.47%
|
|
Call 1300 880 160
Start a chat
Schedule a call
