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Neuren Pharmaceuticals Limited
(Sydney:NEU)
Neuren Pharmaceuticals Limited (NEU) vs. iShares MSCI Australia ETF (EWA)
Neuren Pharmaceuticals Limited Business Overview & Revenue Model
Neuren Pharmaceuticals Limited Earnings Call Summary
Neuren Pharmaceuticals Limited Financial Statement Overview
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 64.63M | 213.24M | 231.93M | 14.55M | 3.20M |
| Gross Profit | 64.61M | 213.22M | 205.17M | 14.54M | 3.19M |
| EBITDA | 22.05M | 175.57M | 199.26M | -670.00K | -10.98M |
| Net Income | 30.44M | 142.04M | 157.08M | 184.00K | -7.79M |
Balance Sheet | |||||
| Total Assets | 342.86M | 409.71M | 247.97M | 43.27M | 40.06M |
| Cash, Cash Equivalents and Short-Term Investments | 296.12M | 222.24M | 228.54M | 40.18M | 36.78M |
| Total Debt | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 4.41M | 45.80M | 42.76M | 1.68M | 803.00K |
| Stockholders Equity | 338.45M | 363.90M | 205.21M | 41.59M | 39.25M |
Cash Flow | |||||
| Free Cash Flow | 125.39M | -11.28M | 184.88M | 3.58M | -9.98M |
| Operating Cash Flow | 125.42M | -11.27M | 184.93M | 3.60M | -9.97M |
| Investing Cash Flow | -88.01M | 4.13M | -211.49M | -19.00K | -10.00K |
| Financing Cash Flow | -33.22M | -8.78M | 3.62M | -2.00K | 22.18M |
Neuren Pharmaceuticals Limited Technical Analysis
Neuren Pharmaceuticals Limited Peers Comparison
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
72 Outperform | AU$501.00M | 14.96 | 15.90% | 0.38% | 7.76% | 1.55% | |
59 Neutral | AU$1.52B | 78.41 | 54.79% | ― | 12.35% | 26.73% | |
55 Neutral | $2.59B | ― | -18.95% | ― | 198.58% | 3.97% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | AU$545.28M | -3.40 | -35.86% | ― | ― | -19.21% | |
41 Neutral | AU$244.18M | -12.98 | -89.70% | ― | 42.05% | -0.84% | |
41 Neutral | AU$76.13M | -2.12 | -42.68% | ― | ― | 63.46% |
Neuren Pharmaceuticals Limited Corporate Events
Neuren Pharmaceuticals has released an investor presentation highlighting its mission to improve the lives of people with neurodevelopmental disabilities through targeted drug development programs. The company also underscores the significant risks and uncertainties inherent in pharmaceutical development, regulatory approvals, clinical trial timelines, patent protection, and future funding needs, signaling the potential variability in its operational and financial outcomes.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals reported 2025 royalty income of A$65 million from Rett syndrome drug DAYBUE, up 15% year on year, and a profit after tax of A$30 million, with cash and short-term investments rising to A$296 million. Although profit declined versus 2024 due to the absence of prior one-off milestone and voucher revenues, the company has generated A$510 million in cumulative DAYBUE income since its 2023 launch and completed a A$50 million share buy-back, with a new program starting in March 2026.
Commercial momentum for DAYBUE continued, with 2025 net sales of US$391 million and the U.S. launch of new powder formulation DAYBUE STIX, while partner Acadia is targeting further sales growth that would lift Neuren’s royalty take in 2026. Strategically, Neuren advanced its NNZ-2591 pipeline, initiating the Koala Phase 3 trial in Phelan-McDermid syndrome, securing Fast Track designation and patent protection in Pitt Hopkins syndrome, adding SYNGAP-1 related disorder and hypoxic ischemic encephalopathy to development, and positioning itself to potentially benefit from the reauthorised U.S. Rare Pediatric Disease priority review voucher program.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals reported a sharp fall in reported revenue and profit for 2025, reflecting the absence of large one-off payments booked in the prior year, even as its core royalty stream and interest income continued to grow. Total revenue from ordinary activities dropped 63% to A$84.8 million and net profit slid 79% to A$30.4 million, but recurring royalty income from Acadia’s DAYBUE rose 15% to A$64.6 million and finance income also increased.
The company lifted research and development spending to A$36.4 million, driven by the start-up of a Phase 3 trial of NNZ-2591 in Phelan-McDermid syndrome, while corporate and administrative costs rose on higher share-based payments. Neuren booked an A$3.3 million loss on forward currency contracts but benefited from an A$8.0 million foreign exchange gain on cash holdings, executed A$39.6 million of on-market share buy-backs instead of paying dividends, and ended the year with net tangible assets of 258.90 cents per share, down from 273.52 cents.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals reported strong financial momentum driven by the continued uptake of DAYBUE in the U.S., as Acadia recorded 2025 net sales of US$391 million, up 12% year-on-year, and Q4 sales of US$110 million, a quarterly record supported by rising patient numbers and broader prescribing among community physicians. Neuren’s 2025 royalty income from DAYBUE rose 15% to A$65 million, and based on Acadia’s 2026 sales guidance of US$460–490 million, the company expects royalties of A$70–77 million while its partner advances European regulatory re-examination and a Phase 3 trial in Japan, underscoring growing global prospects for trofinetide and a strengthening cash-generative base for Neuren.
Neuren Pharmaceuticals reported strong financial momentum driven by the continued uptake of DAYBUE in the U.S., as Acadia recorded 2025 net sales of US$391 million, up 12% year-on-year, and Q4 sales of US$110 million, a quarterly record supported by rising patient numbers and broader prescribing among community physicians. Neuren’s 2025 royalty income from DAYBUE rose 15% to A$65 million, and based on Acadia’s 2026 sales guidance of US$460–490 million, the company expects royalties of A$70–77 million while its partner advances European regulatory re-examination and a Phase 3 trial in Japan, underscoring growing global prospects for trofinetide and a strengthening cash-generative base for Neuren.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals Limited has announced a new on-market share buy-back of its ordinary fully paid shares listed on the ASX under the code NEU. The move signals that the board sees value in the current share price and is willing to deploy capital to repurchase equity, which may support earnings per share and provide a potential uplift for existing shareholders by reducing the number of shares on issue.
The buy-back notification formalises Neuren’s authority to begin acquiring its own shares on the open market in accordance with ASX requirements. While specific terms such as total size or timing were not disclosed in the notice, the decision underscores management’s confidence in the company’s outlook and may influence trading liquidity and capital management perceptions among investors.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals will host an investor webinar on 12 February 2026 to discuss recently announced business updates, offering investors an opportunity to engage directly with management and submit questions. The event underlines the company’s active communication with the market as it advances its approved Rett syndrome therapy DAYBUE and progresses NNZ-2591 through late-stage trials in rare neurodevelopmental disorders, potentially strengthening its position in the niche paediatric neurology space and enhancing long-term value for stakeholders.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals has launched an on-market share buy-back program of up to 5% of its shares on issue, to be conducted over a period of up to 12 months under New Zealand companies law, with purchases and pricing at the company’s discretion and subject to market conditions and regulatory blackout periods. The board argues the current share price materially undervalues Neuren’s assets given its strong cash position and growing DAYBUE franchise, and it plans to fund the buy-back while maintaining full support for ongoing NNZ-2591 development programs, with all repurchased shares to be cancelled, modestly reducing the share count without requiring shareholder approval.
The buy-back program may be varied, suspended or terminated at any time, and Neuren will report the number of shares and average price bought back to the ASX on the following business day, providing transparency for investors. By signalling confidence in its valuation and balance sheet while committing to continued investment in its pipeline, Neuren is using capital management to bolster shareholder returns and reinforce its positioning in the rare neurological disease market.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$27.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals has dosed the first patient in its Koala Phase 3 clinical trial of NNZ-2591 for Phelan-McDermid syndrome, marking the first-ever Phase 3 study in this rare neurodevelopmental disorder, which currently has no approved treatments. The randomized, double-blind, placebo-controlled trial plans to enroll about 160 children aged 3 to 12 across a growing network of U.S. sites, supported by Fast Track, Rare Pediatric Disease and Orphan Drug designations from the FDA; early referral and waitlist numbers suggest strong interest from the patient community, while Neuren’s sponsorship of the 2026 Phelan-McDermid Syndrome Foundation Family Conference underscores its engagement with stakeholders and signals building momentum around NNZ-2591’s late-stage development.
The most recent analyst rating on (AU:NEU) stock is a Hold with a A$15.50 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals has highlighted the reauthorization by the US Congress of the Rare Pediatric Disease Priority Review Voucher program through 30 September 2029, a move that preserves a lucrative incentive for developers of treatments for rare childhood diseases. Under this program, companies that secure FDA approval for drugs targeting designated rare pediatric conditions receive a voucher for priority review of another drug, which can also be sold to third parties—recently fetching as much as US$200 million. Neuren currently holds Rare Pediatric Disease designations for its pipeline asset NNZ-2591 in Phelan-McDermid, Pitt Hopkins and Angelman syndromes, meaning FDA approval in any one of these indications could yield a voucher that Neuren would own outright, potentially strengthening its financial position and strategic flexibility as it advances its rare disease portfolio.
The most recent analyst rating on (AU:NEU) stock is a Hold with a A$15.50 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren reported that FDA written feedback validated its planned IND-opening study for NNZ-2591 in hypoxic ischemic encephalopathy, contingent on additional juvenile animal data before a late-2026 start, while guidance for Pitt Hopkins syndrome confirmed an acceptable endpoint strategy that now requires refined trial design for an initiation target in 2026. The company emphasized it can fund both programs with minimal financial impact, is progressing the Koala Phase 3 trial in Phelan-McDermid syndrome, and sees the regulatory clarity as reinforcing its rare-disease pipeline momentum.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$19.50 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals disclosed that its licensee Acadia Pharmaceuticals has received a negative trend vote from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the marketing authorization application for trofinetide to treat Rett syndrome in the European Union, following an oral explanation to the committee. Acadia plans to pursue a formal re-examination of the opinion once adopted, arguing that clinical trial results and real‑world experience in more than 1,000 patients underpin trofinetide’s benefits and aligning with Neuren’s view that the decision is frustrating for the Rett community; the outcome will influence Neuren’s ability to extend the commercial reach of its lead therapy into the EU market and may affect expectations around access to new treatment options for European patients with this rare neurological disorder.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$19.50 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals has confirmed to the ASX that recent information disclosed by its partner Acadia Pharmaceuticals on projected DAYBUE net sales, including a substantial increase in expected 2028 revenue versus 2025 guidance, is materially important for Neuren’s share price because royalties and milestones from DAYBUE are its only current source of product income. The company detailed the timeline of when it became aware of Acadia’s updated projections, outlined how it complied with continuous disclosure obligations by rapidly reviewing Acadia’s announcements, analyst forecasts and internal models before releasing its own market update, and asserted it has reasonable grounds to reference a projection of approximately US$700 million in global DAYBUE sales in 2028, relying on Acadia’s regulated disclosures in the US.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.50 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals reported that its partner Acadia Pharmaceuticals is projecting global net sales of Rett syndrome therapy DAYBUE to reach about US$700 million in 2028, underpinned by the US rollout of the new DAYBUE STIX powder formulation, enhanced US commercial infrastructure, and anticipated international expansion including potential European approval. Since the 2023 US launch, more than 2,000 Rett patients have been treated with DAYBUE, 12‑month treatment persistence has improved to 55%, the diagnosed US Rett population has grown to roughly 6,000 patients, and regulatory and clinical milestones are advancing with DAYBUE oral solution now approved in Israel and a Phase 3 trofinetide trial in Japan expected to deliver top-line data between late 2026 and early 2027, collectively strengthening Neuren’s commercial and clinical position in rare neurological disorders.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$21.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals has announced that results from its Phase 2 clinical trial of NNZ-2591 in children and adolescents with Phelan-McDermid syndrome have been published in the peer-reviewed journal Neurology Genetics, with the study reporting that the treatment was well tolerated and associated with meaningful improvements in key symptoms as observed by clinicians and caregivers. These Phase 2 data underpin the design of Neuren’s ongoing Koala Phase 3 trial in the United States, a randomized, placebo-controlled study targeting about 160 pediatric patients with Phelan-McDermid syndrome, a rare disorder with no approved therapies and a significant unmet medical need, and the program benefits from US FDA Fast Track, Rare Pediatric Disease and Orphan Drug designations, reinforcing Neuren’s position in the rare neurodevelopmental disease space.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$21.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals has secured Health Canada approval for its Clinical Trial Application for the Koala Phase 3 trial of NNZ-2591 in children aged 3 to 12 with Phelan-McDermid syndrome, allowing Canadian sites to be added to what is the first-ever Phase 3 study in this rare disorder. The trial, which already has US FDA IND clearance, is now enrolling at two activated sites in the United States on both coasts, and the expanded North American footprint marks a significant operational step in advancing NNZ-2591 through late-stage development, potentially strengthening Neuren’s position in the rare paediatric neurodevelopmental disease market and offering new hope to patients and families facing limited treatment options.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals announced that its partner, Acadia Pharmaceuticals, has received FDA approval for DAYBUE STIX, a new powder formulation of trofinetide for Rett syndrome, offering patients and caregivers more flexibility and choice. This approval, based on bioequivalence studies, ensures comparable efficacy and safety to the existing oral solution. DAYBUE STIX is expected to be available in early 2026, with Neuren receiving royalties on sales, potentially impacting its market position and providing new options for stakeholders.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.
Neuren Pharmaceuticals announced a one-month administrative delay in the FDA’s pre-IND meeting for their drug candidate NNZ-2591, now rescheduled for late January 2026. This delay may impact the timeline for developing treatments for hypoxic ischemic encephalopathy (HIE), highlighting the challenges in advancing therapies for rare neurological disorders.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.