| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
One-month administrative delay to FDA meeting for HIE
|
9 Dec 2025 10:38AM |
$19.940 |
$16.340 |
fallen by
18.05%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Application for quotation of securities - NEU
|
24 Nov 2025 5:43PM |
$18.380 |
$16.340 |
fallen by
11.10%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Investor Presentation, 10 November 2025
|
10 Nov 2025 8:46AM |
$18.580 |
$16.340 |
fallen by
12.06%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Record DAYBUE net sales of US$101.1 million in Q3 2025
|
6 Nov 2025 9:59AM |
$20.230 |
$16.340 |
fallen by
19.23%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Record DAYBUEâ„¢ 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 |
$2,071 |
Fast Track granted by FDA for NNZ-2591 in Phelan-McDermid
|
20 Oct 2025 9:28AM |
$20.650 |
$16.340 |
fallen by
20.87%
|
|
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 |
$2,071 |
Change of registered office in Australia
|
17 Oct 2025 4:44PM |
$20.650 |
$16.340 |
fallen by
20.87%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Application for quotation of securities - NEU
|
3 Oct 2025 4:58PM |
$21.500 |
$16.340 |
fallen by
24%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Notification regarding unquoted securities - NEU
|
22 Sep 2025 7:30AM |
$19.820 |
$16.340 |
fallen by
17.56%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Neuren partners with Hope for HIE to support NNZ-2591
|
9 Sep 2025 7:30AM |
$20.800 |
$16.340 |
fallen by
21.44%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Change of Director's Interest Notice
|
8 Sep 2025 7:08PM |
$20.800 |
$16.340 |
fallen by
21.44%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Application for quotation of securities - NEU
|
28 Aug 2025 4:43PM |
$19.510 |
$16.340 |
fallen by
16.25%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Investor Presentation, 27 August 2025
|
27 Aug 2025 11:21AM |
$17.930 |
$16.340 |
fallen by
8.87%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
H1 2025 profit after tax A$15m, up from A$8m in H1 2024
|
27 Aug 2025 9:24AM |
$17.800 |
$16.340 |
fallen by
8.20%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Half Yearly Report and Accounts
|
27 Aug 2025 9:21AM |
$17.800 |
$16.340 |
fallen by
8.20%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Profit after tax increased to A$15.0 million
- Revenue rose by 24% to A$39.7 million
- Royalty income from Acadia Pharmaceuticals
- Total assets of A$331.3 million
- Net assets at A$323.3 million
- Completed A$39.6 million share buy-back
- No dividends declared
- Focus on commercial products and R&D
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 |
$2,071 |
First site initiated for Neuren's PMS Phase 3 trial
|
25 Aug 2025 9:27AM |
$17.170 |
$16.340 |
fallen by
4.83%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- First investigational site initiated in the US for Phase 3 trial of NNZ-2591 for PMS.
- Received IRB approval for the trial.
- First-ever Phase 3 trial in Phelan-McDermid syndrome.
- Approximately 160 children aged 3-12 will participate in a 13-week trial.
- Participants may continue treatment in a 12-month open-label extension.
- Trial is fully funded by Neuren's cash reserves.
- Regulatory alignment achieved with US FDA on trial design.
- Neuren's programs have orphan drug designation in the US.
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 |
$2,071 |
First site initiated for Neuren's PMS Phase 3 trial
|
25 Aug 2025 9:27AM |
$17.170 |
$16.340 |
fallen by
4.83%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- First investigational site initiated in the US for Phase 3 trial of NNZ-2591 in Phelan-McDermid syndrome.
- The Phase 3 trial is for NNZ-2591, targeting Phelan-McDermid syndrome (PMS).
- The trial is randomized, double-blind, placebo-controlled, spanning 13 weeks.
- 160 children aged 3-12 with PMS will be assessed.
- Participants may continue treatment in a 12-month open-label extension.
- Neuren is funding the trial from existing cash reserves.
- Phelan-McDermid syndrome is a serious neurodevelopmental disorder with no approved treatments.
- The trial received approval from the Institutional Review Board (IRB).
- Neuren's programs have orphan drug designation in the US.
- The trial design was aligned with the US FDA during End of Phase 2 and subsequent Type C meetings.
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 |
$2,071 |
Application for quotation of securities - NEU
|
12 Aug 2025 4:12PM |
$17.880 |
$16.340 |
fallen by
8.61%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Neuren adds SYNGAP1-related disorder to NNZ-2591 pipeline
|
8 Aug 2025 9:16AM |
$17.550 |
$16.340 |
fallen by
6.89%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Neuren adds SYNGAP1-related disorder to NNZ-2591 pipeline.
- Positive pre-clinical results with NNZ-2591 in an in-vitro model.
- SYNGAP1-related disorder involves impaired synaptic communication.
- No approved treatments currently exist for SYNGAP1-related disorder.
- Commencement of Phase 3 clinical trial for Phelan-McDermid syndrome.
- NNZ-2591 targets multiple neurodevelopmental disorders.
- Orphan drug designation in the U.S. provides development incentives.
- Neuren partners with Acadia Pharmaceuticals 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 |
$2,071 |
DAYBUE Q2 2025 net sales US$96.1 million up 14% from Q2 2024
|
7 Aug 2025 9:51AM |
$17.010 |
$16.340 |
fallen by
3.94%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- Q2 2025 DAYBUEâ„¢ (trofinetide) net sales were US$96.1 million, up 14% from Q2 2024.
- Neuren Pharmaceuticals earned royalty income of A$14.7 million in Q2 2025.
- Acadia Pharmaceuticals completed expansion of its DAYBUE sales force to boost growth.
- Acadia's full year 2025 US net sales guidance for DAYBUE is US$380 - 405 million.
- European commercial team is being built by Acadia in anticipation of approval in Q1 2026.
- Named patient supply programs initiated in Europe, Israel, and the Rest of the World.
- DAYBUE's persistency rate remains steady above 50% after 12 months of treatment.
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 |
$2,071 |
DAYBUE Q2 2025 net sales US$96.1 million up 14% from Q2 2024
|
7 Aug 2025 9:51AM |
$17.010 |
$16.340 |
fallen by
3.94%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- DAYBUE Q2 2025 net sales reached US$96.1 million, up 14% from Q2 2024.
- Neuren Pharmaceuticals earned Q2 2025 royalty income of A$14.7 million.
- Acadia Pharmaceuticals completed planned expansion of DAYBUE sales force.
- Acadia reiterated full year 2025 DAYBUE US net sales guidance of US$380 - 405 million.
- Record number of patients in the US received DAYBUE shipments.
- Acadia initiated named patient supply programs in Europe and Rest of the World.
- Substantial potential for future growth in the US with many Rett patients yet to try DAYBUE.
- Neuren's programs have orphan drug designation in the United States.
- DAYBUE is approved by the US FDA and Health Canada for treating Rett 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 |
$2,071 |
Change of Director's Interest Notice - J Pilcher
|
22 Jul 2025 9:30AM |
$15.170 |
$16.340 |
risen by
7.71%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Application for quotation of securities - NEU
|
22 Jul 2025 9:21AM |
$15.170 |
$16.340 |
risen by
7.71%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Notification regarding unquoted securities - NEU
|
9 Jul 2025 5:03PM |
$14.180 |
$16.340 |
risen by
15.23%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
Application for quotation of securities - NEU
|
30 Jun 2025 5:49PM |
$14.110 |
$16.340 |
risen by
15.80%
|
|
| Neuren Pharmaceuticals Limited (NEU) ORDINARY FULLY PAID |
Health Care |
$2,071 |
US patent allowed for NNZ-2591 to treat Pitt Hopkins
|
26 Jun 2025 9:25AM |
$12.540 |
$16.340 |
risen by
30.30%
|
|
NEU - Price-sensitive ASX Announcement
Full Release
Key Points
- The US Patent and Trademark Office has allowed a patent for NNZ-2591 for treating Pitt Hopkins syndrome.
- The allowed patent covers both the compound NNZ-2591 and its use as a therapy.
- This strengthens Neuren’s intellectual property protection in the United States.
- Pitt Hopkins syndrome is a rare neurodevelopmental disorder with significant unmet medical needs.
- NNZ-2591 has demonstrated efficacy in pre-clinical studies for Pitt Hopkins syndrome.
- The patent is expected to provide Neuren with commercial and competitive advantages in the US market.
- The move is part of Neuren’s broader strategic focus on rare neurological disease treatments.
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.