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Neuren Pharmaceuticals Limited (AU:NEU)
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Neuren Pharmaceuticals Limited (NEU) AI Stock Analysis

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AU

Neuren Pharmaceuticals Limited

(Sydney:NEU)

78Outperform
Neuren Pharmaceuticals Limited is financially strong with a notable absence of debt, high profitability, and stable equity. While technical indicators are generally positive, the overbought condition warrants caution. The valuation is reasonable, contributing to a favorable overall stock score.

Neuren Pharmaceuticals Limited (NEU) vs. S&P 500 (SPY)

Neuren Pharmaceuticals Limited Business Overview & Revenue Model

Company DescriptionNeuren Pharmaceuticals Limited (NEU) is a biopharmaceutical company headquartered in Australia, focused on developing therapies for neurological disorders. The company specializes in neurodevelopmental disorders such as Rett syndrome, Fragile X syndrome, and other conditions associated with cognitive and social impairments. Neuren's core products include investigational drugs like trofinetide, aimed at improving the quality of life for individuals with these challenging disorders.
How the Company Makes MoneyNeuren Pharmaceuticals Limited primarily generates revenue through the development and commercialization of its pharmaceutical products. The company partners with larger pharmaceutical firms to advance its drug candidates through late-stage clinical trials and eventual market approval. These partnerships often involve licensing agreements, where Neuren receives upfront payments, milestone payments upon reaching specific clinical or regulatory milestones, and royalties on net sales of the drugs once commercialized. Additionally, Neuren may engage in research and development collaborations that contribute to its revenue streams.

Neuren Pharmaceuticals Limited Financial Statement Overview

Summary
Income Statement
Balance Sheet
Cash Flow
Breakdown
Dec 2023Dec 2022Dec 2021Dec 2020Dec 2019
Income StatementTotal Revenue
231.93M14.55M3.20M717.00K495.00K
Gross Profit
205.17M14.54M3.19M711.00K491.00K
EBIT
172.49M-1.60M-11.43M-9.53M-11.57M
EBITDA
199.26M-1.59M-8.22M-8.80M-11.07M
Net Income Common Stockholders
157.08M184.00K-7.79M-9.19M-10.82M
Balance SheetCash, Cash Equivalents and Short-Term Investments
228.54M40.18M36.78M24.19M13.84M
Total Assets
247.97M43.27M40.06M24.95M14.41M
Total Debt
0.000.000.000.000.00
Net Debt
-17.09M-40.18M-36.78M-24.19M-13.84M
Total Liabilities
42.76M1.68M803.00K753.00K559.00K
Stockholders Equity
205.21M41.59M39.25M24.20M13.85M
Cash FlowFree Cash Flow
184.88M3.58M-9.98M-8.08M-11.73M
Operating Cash Flow
184.93M3.60M-9.97M-8.08M-11.72M
Investing Cash Flow
-211.49M-19.00K-10.00K-6.00K-12.00K
Financing Cash Flow
3.62M-2.00K22.18M19.14M1.86M

Neuren Pharmaceuticals Limited Technical Analysis

Technical Analysis Sentiment
Positive
Last Price12.62
Price Trends
50DMA
11.65
Positive
100DMA
12.34
Positive
200DMA
13.50
Negative
Market Momentum
MACD
0.28
Negative
RSI
61.05
Neutral
STOCH
80.57
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AU:NEU, the sentiment is Positive. The current price of 12.62 is above the 20-day moving average (MA) of 10.84, above the 50-day MA of 11.65, and below the 200-day MA of 13.50, indicating a neutral trend. The MACD of 0.28 indicates Negative momentum. The RSI at 61.05 is Neutral, neither overbought nor oversold. The STOCH value of 80.57 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AU:NEU.

Neuren Pharmaceuticals Limited Peers Comparison

Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
AUNEU
78
Outperform
$1.54B10.9351.39%―-8.06%-10.13%
AUPTX
56
Neutral
AU$36.24M―-36.95%――11.11%
AURAC
54
Neutral
AU$204.99M―-37.20%――32.02%
52
Neutral
$5.23B3.70-41.86%2.84%16.58%-0.16%
AUPAR
40
Underperform
$110.99M―-46.65%―96.20%80.90%
AUACR
37
Underperform
$9.37M―-132.58%―-92.98%-741.67%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AU:NEU
Neuren Pharmaceuticals Limited
12.80
-6.51
-33.71%
AU:ACR
Acrux
0.02
-0.04
-63.49%
AU:PTX
Prescient Therapeutics Limited
0.05
0.01
25.00%
AU:PAR
Paradigm Biopharmaceuticals
0.30
0.03
11.11%
AU:RAC
Race Oncology Ltd.
1.16
-0.16
-12.12%

Neuren Pharmaceuticals Limited Earnings Call Summary

Earnings Call Date:Feb 27, 2025
(Q4-2023)
|
% Change Since: -11.13%|
Next Earnings Date:Aug 26, 2025
Earnings Call Sentiment Positive
The earnings call highlighted Neuren's strong financial performance, significant cash growth, and successful collaboration with Acadia. Positive trial results for NNZ-2591 and an expanded global reach were significant achievements. However, challenges such as tax liabilities, exchange rate impacts, and share price volatility were noted. Overall, the positive aspects and strategic advancements overshadow the lowlights.
Q4-2023 Updates
Positive Updates
Record Profit and Cash Growth
Neuren reported a profit of AUD 157 million, with cash growing from $40 million to $229 million without any capital raising.
Strong Financial Performance from Acadia Partnership
Neuren received $27 million of royalty income, $59 million from DAYBUE's first commercial sale milestone, and $146 million from an expanded deal with Acadia.
Successful DAYBUE Sales
DAYBUE net sales in Q4 reached USD 87 million, hitting the top of Acadia's guidance. Total sales for the partial year were USD 177 million, with 2024 guidance between USD 370 million and USD 420 million.
Expanded Global Reach
The deal with Acadia expanded to include markets outside North America, bringing in USD 100 million upfront, with tiered royalties from mid-teens to low 20s expected once they reach the market.
Positive Phase II Trial Results for NNZ-2591
Outstanding results announced for the Phelan-McDermid syndrome trial, exceeding expectations and showing consistent improvements across multiple efficacy measures.
Negative Updates
Exchange Rate Impact
There was an $8.2 million expense due to exchange losses, partially offset by foreign exchange gains.
Tax Liabilities
The company faced a $48 million tax charge, with $18 million withheld in the U.S., leaving a $30 million tax liability.
Seasonality Concerns
DAYBUE sales are expected to be lower in Q1 2024 due to seasonality effects, which could impact perceived growth.
Share Price Volatility
Neuren's share price experienced significant volatility, influenced by external reports and market reactions to announcements.
Company Guidance
During Neuren's 2023 earnings call, CEO Jonathan Pilcher highlighted several key financial metrics. The company reported a profit of AUD 157 million, fueled by AUD 27 million in royalty income, a USD 59 million milestone payment from DAYBUE's first commercial sale in the U.S., and USD 146 million from an expanded deal with Acadia. Cash reserves increased from AUD 40 million to AUD 229 million without any capital raising. Neuren anticipates royalty income between AUD 61 million and AUD 70 million next year, based on a royalty rate that ranges from 10% to 12%. Additionally, Neuren is expecting USD 50 million in milestone payments as DAYBUE's sales exceed USD 250 million. Neuren's R&D expenses totaled AUD 27 million, with significant efforts directed towards four Phase II trials and preparations for Phase III. Acadia's DAYBUE guidance for 2024 forecasts USD 370 million to USD 420 million in sales, indicating substantial growth from 2023's USD 177 million.

Neuren Pharmaceuticals Limited Corporate Events

State Street Becomes Substantial Holder in Neuren Pharmaceuticals
May 5, 2025

Neuren Pharmaceuticals Limited has announced that State Street Corporation and its subsidiaries have become substantial holders in the company as of May 1, 2025. This development indicates a significant investment and interest from State Street, potentially impacting Neuren Pharmaceuticals’ market positioning and shareholder dynamics.

Neuren Pharmaceuticals Updates on Market Buy-Back Progress
May 5, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back of ordinary fully paid securities. As of the latest announcement, the company has bought back a total of 2,933,372 securities, with an additional 1,938 securities purchased on the previous day. This buy-back initiative is part of Neuren’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Strengthens Executive Team with Key Appointment
May 2, 2025

Neuren Pharmaceuticals has appointed Daryl DeKarske as Chief Regulatory Officer, bringing his extensive experience in global regulatory strategy and orphan drug indications to the company. This strategic addition is expected to significantly aid Neuren’s efforts in advancing NNZ-2591 for global markets, particularly in the Phase 3 program for Phelan-McDermid syndrome, thereby strengthening its position in the field of neurological disorder treatments.

Neuren Pharmaceuticals Updates on Ongoing Share Buy-Back Program
May 1, 2025

Neuren Pharmaceuticals Limited announced an update regarding its ongoing on-market buy-back program. As of May 2, 2025, the company has repurchased a total of 2,910,919 ordinary fully paid securities, with an additional 22,453 securities bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to optimize its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Apr 30, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program. As of May 1, 2025, the company has repurchased a total of 2,910,919 ordinary fully paid shares, including 34,962 shares bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to optimize its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Apr 29, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, reporting the purchase of 25,511 ordinary fully paid securities on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Ongoing Securities Buy-Back
Apr 28, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back of ordinary fully paid securities. As of April 29, 2025, the company reported a total of 2,782,784 securities bought back before the previous day and an additional 67,662 securities bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Releases Online Meeting Guide for Shareholders
Apr 24, 2025

Neuren Pharmaceuticals Limited has released an online meeting guide for shareholders and proxies to attend and vote in their upcoming meeting. The guide provides detailed instructions on how to access the meeting, register, and participate in voting, emphasizing the need for shareholders to have their shareholder number, postcode, and, if applicable, proxy number ready. This announcement is crucial for ensuring smooth participation in the meeting, which could impact shareholder engagement and decision-making processes.

Neuren Pharmaceuticals Announces Hybrid Annual Shareholders’ Meeting
Apr 24, 2025

Neuren Pharmaceuticals Limited has announced its Annual Shareholders’ Meeting scheduled for 27 May 2025, to be held both physically in Melbourne and online. This hybrid meeting format allows shareholders to participate, vote, and ask questions either in person or via an online platform, reflecting the company’s commitment to accessibility and shareholder engagement.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Apr 24, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing share buy-back program. As of April 24, 2025, the company has repurchased a total of 2,781,925 ordinary fully paid securities, including 32,737 securities bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Apr 22, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program. As of April 23, 2025, the company has repurchased a total of 2,686,825 ordinary fully paid securities, with 62,363 bought back on the previous day. This strategic move is part of the company’s efforts to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Apr 21, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing share buy-back program. As of April 22, 2025, the company has repurchased a total of 2,686,825 ordinary fully paid shares, including 36,140 shares bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to enhance shareholder value and optimize its capital structure, reflecting confidence in its financial position and future prospects.

Neuren Pharmaceuticals Continues Daily Securities Buy-Back
Apr 16, 2025

Neuren Pharmaceuticals Limited has announced a daily buy-back of its ordinary fully paid securities, with a total of 83,848 securities bought back on the previous day. This buy-back initiative is part of the company’s ongoing efforts to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Director Increases Shareholding
Apr 16, 2025

Neuren Pharmaceuticals Limited announced a change in the director’s interest, with Director Joseph Basile acquiring 14,500 ordinary shares through an on-market trade. This acquisition increases his total holdings to 35,906 shares, reflecting a significant personal investment in the company. Such a move could indicate confidence in the company’s future prospects and may positively influence stakeholder perceptions.

Neuren Pharmaceuticals Advances Phase 3 Trial for Phelan-McDermid Syndrome
Apr 14, 2025

Neuren Pharmaceuticals announced the confirmation of primary endpoints for its Phase 3 trial of NNZ-2591 in Phelan-McDermid syndrome (PMS) following a productive meeting with the FDA. This pivotal trial, set to commence mid-2025, marks a significant step forward as the first-ever Phase 3 trial for PMS in children, aiming to address the unmet medical needs in this area. The trial will assess improvements in receptive communication and overall symptom changes, building on positive results from Phase 2 trials. Neuren’s financial stability ensures no additional funding is required for the trial, highlighting its strong position in advancing treatments for rare neurological disorders.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Apr 6, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing share buy-back program. The company has repurchased a total of 2,416,721 securities before the previous day and an additional 150,116 securities on the previous day. This buy-back initiative reflects Neuren’s strategic decision to optimize its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Apr 3, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, indicating that a total of 2,295,502 securities have been bought back prior to the previous day, with an additional 121,219 securities acquired on the previous day. This buy-back initiative reflects the company’s strategic efforts to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Announces Cessation of Securities via Buy-Back
Apr 2, 2025

Neuren Pharmaceuticals Limited has announced the cessation of 1,269,250 ordinary fully paid securities due to an on-market buy-back, effective March 31, 2025. This move is part of the company’s capital management strategy and may impact its stock liquidity and shareholder value, reflecting its ongoing efforts to optimize financial performance and shareholder returns.

Neuren Pharmaceuticals Updates on Buy-Back Program
Apr 2, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing buy-back program, with a daily buy-back notification detailing the acquisition of 130,100 ordinary fully paid securities on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Releases 2024 Corporate Governance Statement
Apr 2, 2025

Neuren Pharmaceuticals Limited has released its corporate governance statement for the financial year ending December 31, 2024. The statement, which has been approved by the board, outlines the company’s adherence to the ASX Corporate Governance Council’s principles and recommendations. This disclosure is part of Neuren’s commitment to transparency and accountability, potentially strengthening its position within the industry and providing assurance to stakeholders about its governance practices.

Neuren Pharmaceuticals Releases 2024 Annual Report
Apr 2, 2025

Neuren Pharmaceuticals Limited has released its Annual Report for 2024, highlighting its commitment to improving the lives of individuals with neurodevelopmental disabilities. The report includes an operating review, financial statements, and insights into the company’s environmental, social, and governance practices, reflecting its strategic focus and operational progress.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Apr 1, 2025

Neuren Pharmaceuticals Limited announced an update on its ongoing share buy-back program, with a total of 2,072,302 securities bought back before the previous day and an additional 93,100 securities bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value, reflecting a proactive approach to financial management and market positioning.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 31, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing share buy-back program. As of April 1, 2025, the company has repurchased a total of 2,072,302 ordinary fully paid securities, with 98,349 bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Buy-Back Program
Mar 30, 2025

Neuren Pharmaceuticals Limited announced an update on its ongoing buy-back program, detailing the acquisition of 41,082 ordinary fully paid securities on the previous day, adding to a total of 1,932,871 securities bought back to date. This buy-back initiative is part of the company’s strategy to manage its capital structure, potentially enhancing shareholder value and reflecting confidence in its financial health.

Neuren Pharmaceuticals Updates on Ongoing Buy-Back Program
Mar 27, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back program. As of the latest update, the company has repurchased a total of 1,896,260 securities, with 36,611 securities bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Advances NNZ-2591 for Newborn Brain Injury Treatment
Mar 27, 2025

Neuren Pharmaceuticals has initiated the development of NNZ-2591 to treat hypoxic-ischemic encephalopathy (HIE) in newborns, a severe brain injury caused by inadequate oxygen or blood flow. This condition affects thousands of infants globally and is a leading cause of neonatal death and disability. Currently, the only treatment is hypothermia, which has limited effectiveness. Neuren aims to offer a more comprehensive solution with NNZ-2591, which has shown promise in preclinical models and may qualify for Orphan Drug and Rare Pediatric disease designations from the FDA. The company plans a pre-IND meeting with the FDA in late 2025, aiming to improve long-term outcomes for affected children.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Mar 27, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, reporting the acquisition of 117,556 ordinary fully paid securities on the previous day. This buy-back initiative, which began in November 2024, is part of the company’s strategy to optimize its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 25, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, reporting the purchase of 40,905 ordinary fully paid securities on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates Share Buy-Back Progress
Mar 24, 2025

Neuren Pharmaceuticals Limited announced an update regarding its ongoing share buy-back program. As of March 24, 2025, the company has repurchased a total of 1,688,181 ordinary fully paid securities, including 37,490 securities bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 20, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing share buy-back program. As of the latest announcement, the company has repurchased a total of 1,641,514 ordinary fully paid securities, with an additional 9,177 securities bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 19, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, reporting the purchase of 16,341 ordinary fully paid securities on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Ongoing Share Buy-Back
Mar 18, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back of ordinary fully paid securities. As of March 19, 2025, the company has repurchased a total of 1,625,173 securities, indicating a strategic move to potentially enhance shareholder value and optimize capital structure. This buy-back could impact the company’s market positioning by signaling confidence in its financial health and future prospects.

Neuren Pharmaceuticals Updates on Buy-Back Program
Mar 17, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back program. As of March 18, 2025, the company reported buying back a total of 1,625,156 ordinary fully paid securities, including 21,905 securities purchased on the previous day. This buy-back initiative is part of Neuren’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Mar 16, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program. As of March 17, 2025, the company has bought back a total of 1,603,251 ordinary fully paid securities, with 35,093 acquired on the previous day. This buy-back initiative is part of Neuren’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 13, 2025

Neuren Pharmaceuticals Limited announced an update on their ongoing share buy-back program, with a total of 48,503 ordinary fully paid securities bought back on the previous day, adding to a cumulative total of 1,519,655 securities. This buy-back initiative is part of the company’s strategy to optimize its capital structure, potentially enhancing shareholder value and reflecting confidence in its financial position.

Neuren Pharmaceuticals Updates on Securities Buy-Back
Mar 12, 2025

Neuren Pharmaceuticals Limited announced an update regarding its ongoing on-market buy-back of ordinary fully paid securities. As of March 13, 2025, the company has repurchased a total of 1,519,655 securities, including 118,000 bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to manage its capital structure and potentially enhance shareholder value, indicating a proactive approach in optimizing its financial operations.

Neuren Pharmaceuticals Updates on Securities Buy-Back Program
Mar 11, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back program. As of the latest announcement, the company has repurchased a total of 1,288,620 securities, with an additional 113,035 securities bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to manage its capital structure and potentially enhance shareholder value.

Vanguard Group Acquires Significant Stake in Neuren Pharmaceuticals
Mar 11, 2025

Vanguard Group has become a substantial holder in Neuren Pharmaceuticals Limited, acquiring a 5.023% voting power through various mutual funds and accounts. This acquisition highlights Vanguard’s strategic interest in Neuren, potentially impacting the company’s market dynamics and signaling confidence in its future prospects.

Neuren Pharmaceuticals Announces Quotation of New Securities
Mar 11, 2025

Neuren Pharmaceuticals Limited has announced the quotation of 300,000 ordinary fully paid securities on the Australian Securities Exchange (ASX) as of March 11, 2025. This move is part of the company’s strategy to enhance its financial flexibility and support ongoing projects, potentially impacting its market position and providing new opportunities for stakeholders.

Neuren Pharmaceuticals Updates on Share Buy-Back Progress
Mar 10, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, revealing that a total of 58,471 ordinary fully paid securities were bought back on the previous day, adding to the cumulative total of 1,230,149 securities repurchased. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value, reflecting a proactive approach in optimizing its financial operations.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 9, 2025

Neuren Pharmaceuticals Limited has announced an update on its ongoing share buy-back program, with a total of 78,353 securities bought back on the previous day, adding to the cumulative total of 1,151,796 securities repurchased. This buy-back initiative reflects the company’s strategic efforts to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 5, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back program. As of the latest notification, the company has repurchased a total of 1,022,826 ordinary fully paid securities, with an additional 89,887 securities bought back on the previous day. This buy-back initiative is part of Neuren’s strategy to optimize its capital structure and potentially enhance shareholder value.

Vanguard Group Ceases Substantial Holding in Neuren Pharmaceuticals
Mar 5, 2025

Neuren Pharmaceuticals Limited has announced that Vanguard Group, Inc. and its controlled entities have ceased to be a substantial holder in the company as of February 28, 2025. This change in shareholding could impact the company’s market perception and investor confidence, as Vanguard Group was a significant stakeholder with notable voting power.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 4, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing on-market buy-back program, with a total of 104,806 ordinary fully paid securities bought back on the previous day. This buy-back initiative is part of the company’s strategy to manage its capital structure and potentially enhance shareholder value.

Neuren Pharmaceuticals Updates on Share Buy-Back Program
Mar 3, 2025

Neuren Pharmaceuticals Limited has announced an update regarding its ongoing share buy-back program. The company reported the repurchase of 114,968 ordinary fully paid securities on the previous day, adding to a total of 803,052 securities bought back prior. This buy-back initiative is part of Neuren’s strategy to enhance shareholder value and optimize its capital structure, reflecting confidence in its financial position and future prospects.

Neuren Pharmaceuticals Reports Cessation of Securities
Mar 3, 2025

Neuren Pharmaceuticals Limited announced the cessation of 70,000 securities due to the lapse of conditional rights, as the conditions were not met or became incapable of being satisfied. This development may impact the company’s capital structure and could have implications for stakeholders regarding the company’s financial strategies and market positioning.

Neuren Pharmaceuticals Reports 2024 Full-Year Results
Feb 28, 2025

Neuren Pharmaceuticals Limited has released its 2024 full-year results, highlighting its commitment to improving the lives of individuals with neurodevelopmental disabilities. The announcement underscores the company’s ongoing efforts in drug development and manufacturing, while also acknowledging the inherent risks and uncertainties in the pharmaceutical industry, such as regulatory challenges and clinical trial delays.

Neuren Pharmaceuticals Achieves Major Sales Milestone with DAYBUE™
Feb 28, 2025

Neuren Pharmaceuticals has received a US$50 million sales milestone payment following the successful commercialization of DAYBUE™ (trofinetide) in North America, where 2024 net sales reached US$348.4 million. This milestone reflects the growing market presence of DAYBUE and highlights Neuren’s strategic partnership with Acadia Pharmaceuticals, positioning the company strongly within the neurological disorder treatment industry.

Neuren Pharmaceuticals Achieves Record Income and Expands Global Reach
Feb 28, 2025

Neuren Pharmaceuticals reported a record comprehensive income of A$166 million for 2024, driven by strong sales and royalties from its product DAYBUE™. The company is poised for further growth with the approval of DAYBUE™ in Canada and ongoing regulatory processes in Europe and Japan. Neuren’s financial success is further supported by its strategic partnership with Acadia Pharmaceuticals, which contributed significantly to its income through royalties and milestone payments. The company is also advancing its NNZ-2591 product, which has shown promising Phase 2 trial results, positioning Neuren for continued expansion in the neurodevelopmental disorder treatment market.

Neuren Pharmaceuticals Reports Strong Comprehensive Income Amid Currency Changes
Feb 28, 2025

Neuren Pharmaceuticals Limited reported a total comprehensive income of A$166.2 million for 2024, despite a decrease in revenue and profit from ordinary activities compared to 2023. The company experienced a significant impact on its financial statements due to a change in functional currency from Australian dollars to US dollars, which resulted in a foreign currency translation gain. Revenue was primarily driven by royalties and milestone payments under a licensing agreement with Acadia Pharmaceuticals, with notable contributions from the sale of a Rare Disease Priority Review Voucher. Research and development costs increased due to ongoing clinical trials, while corporate expenses decreased following previous bonuses related to regulatory milestones.

Neuren Pharmaceuticals to Announce 2024 Financial Results and Host Investor Webinar
Feb 27, 2025

Neuren Pharmaceuticals announced that it will report its full-year 2024 financial results and host an investor webinar on February 28, 2025. The announcement follows the confirmation of the DAYBUE™ (trofinetide) royalty for Q4 2024, which will be included in the company’s audited financial statements. This development highlights Neuren’s ongoing efforts to strengthen its market position in the neurological drug therapy sector, with potential implications for stakeholders as the company continues to advance its drug candidates.

Neuren Pharmaceuticals Sees Robust Growth in DAYBUE Sales
Feb 27, 2025

Neuren Pharmaceuticals reported significant growth in the sales of DAYBUE™ (trofinetide) in 2024, with net sales reaching US$348.4 million in the United States, marking a 97% increase from 2023. Acadia Pharmaceuticals, Neuren’s partner, is implementing strategies to further boost adoption among Rett syndrome patients, with plans to expand sales in Canada and Europe. Neuren anticipates substantial royalties from these sales, projecting between A$62 million and A$67 million for 2025. This growth positions Neuren strongly in the neurological disorder treatment market, highlighting the potential for further expansion and increased shareholder value.

Vanguard Group Acquires Substantial Stake in Neuren Pharmaceuticals
Feb 24, 2025

Neuren Pharmaceuticals Limited has announced that The Vanguard Group, a major investment management company, has become a substantial holder in the company with a 5% voting power, equating to 6,503,840 ordinary shares. This development signifies a significant vote of confidence from a leading global investment firm, potentially enhancing Neuren’s market positioning and investor appeal.

Neuren Pharmaceuticals Receives FDA Fast Track Designation for NNZ-2591 in Pitt Hopkins Syndrome
Feb 19, 2025

Neuren Pharmaceuticals announced that the FDA has granted Fast Track designation for their drug candidate NNZ-2591 for treating Pitt Hopkins syndrome, a serious neurodevelopmental condition with no current approved treatments. This designation is expected to expedite the drug’s development and review process, potentially providing a significant advancement in treatment options for the syndrome. In a Phase 2 clinical trial, NNZ-2591 showed promising results, with 82% of participants experiencing improvements in key developmental areas, which underscores the drug’s potential impact on addressing unmet medical needs.

Neuren Pharmaceuticals Gains Financial Boost from Voucher Sale
Feb 7, 2025

Neuren Pharmaceuticals announced the receipt of its one-third share of the net proceeds from the sale of a Rare Pediatric Disease Priority Review Voucher, which totaled $150 million. This voucher was awarded following the FDA approval of DAYBUE™ for Rett syndrome, with Neuren’s partner, Acadia Pharmaceuticals, managing the sale. The financial boost from this transaction potentially strengthens Neuren’s operations and supports its ongoing drug development efforts, enhancing its positioning within the pharmaceutical industry focused on rare neurological disorders.

Neuren Pharmaceuticals Secures FDA Type C Meeting for Phelan-McDermid Syndrome Trial
Feb 6, 2025

Neuren Pharmaceuticals announced that the FDA has granted a Type C Meeting to discuss the primary efficacy endpoints for its Phase 3 clinical trial program of NNZ-2591, aimed at treating Phelan-McDermid syndrome. This step follows positive outcomes from a prior Type B Meeting, marking progress toward the commencement of the first-ever Phase 3 trial for this condition in children, reflecting Neuren’s strategic advancement in addressing unmet medical needs in neurodevelopmental disorders.

Neuren Pharmaceuticals to Present at 2025 Autism Research Meeting
Feb 5, 2025

Neuren Pharmaceuticals announced its participation in the 2025 International Society for Autism Research Annual Meeting, where it will present findings on genetic testing for autism spectrum disorders. This presentation highlights the shortcomings in current genetic testing methodologies, aiming to improve diagnosis for children with developmental delays. Participation in this conference emphasizes Neuren’s commitment to advancing research in autism and its broader focus on neurological disorders, potentially impacting stakeholders by enhancing the company’s industry positioning and fostering further advancements in genetic testing.

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