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Neuren Pharmaceuticals (ASX:NEU) — Material Events

ASX:NEU · 23 articles in the last 12 months · 100% assessed

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Major 1 article Significant 18 articles Notable 4 articles Not Assessed 0 articles
Major ≥90 Significant 75–89 Notable 50–74 Routine <50 Not assessed
Significant Score 75–89
18
Health Canada Greenlights Neuren’s Phase 3 Trial for Rare Syndrome DrugMedium
Health Canada approves Neuren's Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome
22 Dec 2025 ·Clinical Trial Update ·85
Neuren’s DAYBUE Royalties Hit Record A$65M as 2026 Sales Set to SurgeMedium
Neuren reports record 2025 royalties from DAYBUE with strong 2026 sales guidance
26 Feb 2026 ·Earnings Update ·85
Neuren Pharmaceuticals Posts 88% Profit Surge, Advances NNZ-2591 Phase 3 TrialMedium
Neuren Pharmaceuticals posts 88% profit rise, advances NNZ-2591 Phase 3 trial, completes $39.6M share buy-back
27 Aug 2025 ·Appendix 4D Half-year report ·85
Neuren’s DAYBUE Royalties Climb 16% as Patient Numbers Hit Record HighMedium
Neuren Q2 2025 royalties rise 16% on DAYBUE sales growth; full-year guidance reiterated
7 Aug 2025 ·Quarterly Sales and Royalty Update ·85
CHMP Recommends EU Approval for Neuren’s DAYBU to Treat Rett SyndromeMedium
CHMP recommends EU approval for Neuren's DAYBU® to treat Rett syndrome
29 June 2026 ·Regulatory Approval Update ·85
FDA Fast Tracks Neuren’s NNZ-2591 for Phelan-McDermid SyndromeMedium
Neuren’s NNZ-2591 receives FDA Fast Track for Phelan-McDermid syndrome
20 Oct 2025 ·ASX Announcement ·85
Neuren Hits Record DAYBUE Sales, Royalty Income Surges 24% in Q3 2025Medium
Neuren reports record Q3 DAYBUE sales and raises royalty guidance amid expanding patient base
6 Nov 2025 ·Quarterly Sales Update ·85
FDA Greenlights DAYBUE STIX Powder for Rett Syndrome, Boosting Neuren RoyaltiesMedium
FDA approves new DAYBUE STIX powder formulation for Rett syndrome; Neuren to receive royalties
15 Dec 2025 ·Regulatory Approval Announcement ·85
Neuren’s DAYBUE Set to Hit US$700m Sales by 2028 with New US and Global GrowthMedium
Neuren's DAYBUE sales projected to hit US$700m by 2028 with US and international growth
14 Jan 2026 ·ASX Announcement ·85
Neuren’s DAYBUE Sales Rise 20% as Japan Trial AcceleratesMedium
Neuren Q1 2026 DAYBUE sales up 20%, royalties rise 23%, Japan trial accelerated
7 May 2026 ·Quarterly Sales and Operational Update ·85
Neuren posts A$30m profit, advances NNZ-2591 Phase 3 and launches share buy-backMedium
Neuren Pharmaceuticals posts A$30.4m profit in 2025, advances NNZ-2591 Phase 3 trial, initiates share buy-back
24 Apr 2026 ·Annual Report ·85
Neuren’s Partner Acadia Pushes for EU Re-Examination of Trofinetide ApprovalMedium
Neuren's partner Acadia to seek CHMP re-examination for trofinetide Rett syndrome approval
3 Mar 2026 ·Regulatory Update ·80
Neuren Launches First US Site for Phelan-McDermid Phase 3 TrialMedium
Neuren launches first US site for Phase 3 trial of NNZ-2591 in Phelan-McDermid syndrome
25 Aug 2025 ·Clinical Trial Initiation Announcement ·80
Neuren Launches Pioneering Phase 3 Trial for Rare Phelan-McDermid Syndrome TreatmentMedium
Neuren initiates Phase 3 trial dosing for rare Phelan-McDermid syndrome treatment
6 Feb 2026 ·Clinical Trial Update ·75
Neuren Confirms DAYBUE Sales Projection Could Boost Royalties to $700m by 2028Medium
Neuren Pharmaceuticals confirms material impact of DAYBUE 2028 sales projection and compliance with ASX rules
19 Jan 2026 ·ASX Aware Letter Response ·75
Neuren Advances PMS Treatment with Published Phase 2 Trial and Ongoing Phase 3 RecruitmentMedium
Neuren publishes positive Phase 2 trial results for NNZ-2591 in PMS; Phase 3 Koala trial recruiting
7 Jan 2026 ·Clinical Trial Update ·75
Neuren Expands NNZ-2591 Pipeline with SYNGAP1 Disorder After Promising Lab ResultsMedium
Neuren Adds SYNGAP1-Related Disorder to NNZ-2591 Pipeline After Positive Pre-Clinical Results
8 Aug 2025 ·ASX Announcement ·75
Neuren Launches 5% Share Buy-Back Amid Undervaluation ClaimsMedium
Neuren launches up to 5% on-market share buy-back citing undervaluation and strong cash flow
11 Feb 2026 ·Share Buy-Back Announcement ·75
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No articles in this tier for the last 12 months.