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Neuren Pharmaceuticals
Neuren Pharmaceuticals (NEU) investor relations material
Neuren Pharmaceuticals Investor update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Investor update summary11 Feb, 2026
Share buyback program and financial position
Approved a new on-market buyback of up to 5% of shares, reflecting confidence in future prospects and strong cash position supported by DAYBUE franchise cash flows.
Buyback will be conducted at management's discretion over up to 12 months, with flexibility to vary, suspend, or terminate based on market and operational factors.
Shares bought back will be cancelled, reducing total shares on issue; daily notifications to ASX will be provided.
Board views current share price as materially undervaluing assets, with analyst consensus at $24.40 per share and all analysts rating as buy.
Buyback will not impact funding or progress of key development programs, and is seen as the right move given recent share price volatility.
Regulatory and clinical program updates
Trofinetide received a negative trend vote from the CHMP in Europe; Acadia will request reexamination, with a new review team to be appointed.
U.S. and international named patient programs remain the main revenue drivers, with 2023 royalty guidance of AUD 63–66 million based on Acadia’s net sales.
DAYBUE STIX powder formulation launching in U.S. Centers of Excellence, expected to broaden patient uptake and improve persistence rates.
DAYBUE and DAYBUE STIX are FDA-approved for Rett syndrome, with global licensing to Acadia Pharmaceuticals.
NNZ-2591 development priorities and trial progress
Phelan-McDermid syndrome (PMS), Pitt Hopkins syndrome, and HIE are prioritized for maximum commercial and patient impact, with leadership positions targeted.
PMS phase III (Koala trial) has dosed its first patient, with 160-patient enrollment target and multiple U.S. sites opening throughout H1 2024.
FDA feedback for HIE and Pitt Hopkins provides clear paths, though additional juvenile animal data is required for HIE and further endpoint discussions for Pitt Hopkins.
Targeting initiation of HIE and Pitt Hopkins phase II/III studies by year-end.
NNZ-2591 is in Phase 3 for Phelan-McDermid syndrome and showed positive Phase 2 results in Pitt Hopkins and Angelman syndromes.
What conditions would suspend or terminate buy-back?
What is the primary funding source for NNZ-2591?
What are the next steps for Pitt Hopkins and Angelman?
Explain PRV's impact on Neuren's valuation
How to address Pitt Hopkins trial sample size
Assess DAYBUE STIX expected impact
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Next Neuren Pharmaceuticals earnings date
H2 202527 Feb, 2026
Neuren Pharmaceuticals
Next Neuren Pharmaceuticals earnings date
H2 202527 Feb, 2026
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Frequently asked questions
Neuren Pharmaceuticals Limited is an Australia-based biopharmaceutical company focused on developing new therapies for neurodevelopmental disorders, including conditions that manifest in early childhood and are characterized by impaired brain cell connections and signaling. The company has a deep expertise in the field, accumulated through extensive clinical development efforts. Neuren Pharmaceuticals has gained recognition for developing the FDA-approved treatment, DAYBUE™ (trofinetide), specifically for Rett syndrome, marking a significant advancement in the treatment of this condition. Furthermore, the company is advancing its research and development pipeline with therapies aimed at addressing a range of neurodevelopmental disorders. The company is headquartered in Melbourne, Victoria, and its shares are listed on the ASX.
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