Neuren Pharmaceuticals（NURP.F）株式概要ニューレン・ファーマシューティカルズ・リミテッド（Neuren Pharmaceuticals Limited）はバイオ医薬品会社で、神経疾患の治療薬を開発している。 詳細NURP.F ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長6/6過去の実績2/6財務の健全性6/6配当金0/6報酬当社が推定した公正価値より82%で取引されている 収益は年間44.54%増加すると予測されています リスク分析株式の流動性は非常に低い すべてのリスクチェックを見るNURP.F Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$8.8865.9% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-13m259m2016201920222025202620282031Revenue AU$258.9mEarnings AU$121.9mAdvancedSet Fair ValueView all narrativesNeuren Pharmaceuticals Limited 競合他社Phibro Animal HealthSymbol: NasdaqGM:PAHCMarket cap: US$1.4bCollegium PharmaceuticalSymbol: NasdaqGS:COLLMarket cap: US$1.1bXeris Biopharma HoldingsSymbol: NasdaqGS:XERSMarket cap: US$1.1bHarmony Biosciences HoldingsSymbol: NasdaqGM:HRMYMarket cap: US$1.7b価格と性能株価の高値、安値、推移の概要Neuren Pharmaceuticals過去の株価現在の株価AU$8.8852週高値AU$14.8052週安値AU$7.70ベータ1.561ヶ月の変化0.57%3ヶ月変化4.11%1年変化8.63%3年間の変化0.28%5年間の変化844.15%IPOからの変化1,513.64%最新ニュースお知らせ • Apr 25Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026. Location: racv city club, level 2, bayside 4a/b, 501 bourke st, melbourne vic 3000 Australiaお知らせ • Apr 24Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025. Location: the event centre, level 5, tower 2, 727 collins st, melbourne vic 3000 Australiaお知らせ • Feb 27Neuren Pharmaceuticals Limited to Report Fiscal Year 2024 Results on Feb 28, 2025Neuren Pharmaceuticals Limited announced that they will report fiscal year 2024 results on Feb 28, 2025お知らせ • May 28Neuren Phase 2 Trial Shows Significant Improvements in Pitt Hopkins SyndromeNeuren Pharmaceuticals announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Statistically significant improvement from baseline was observed by both clinicians and caregivers from treatment, across all 4 efficacy measures that were specifically designed to assess the core characteristics of PTHS. There are no approved treatments for PTHS despite its severely debilitating impact on the lives of patients, as well as their parents and siblings. The open label Phase 2 trial in 16 children aged 3 to 17 years (mean age 9 years) at five hospitals in the United States examined safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591. NNZ-2591 was administered to all subjects as an oral liquid dose twice daily, with escalation in two stages up to the target dose of 12 mg/kg during the first 6 weeks of treatment, subject to independent review of safety and tolerability data. The study commenced with at least 4 weeks of screening and observation to thoroughly define baseline characteristics prior to treatment, followed by the treatment period of 13 weeks. A follow-up assessment was made 2 weeks after the end of treatment. The primary endpoints of this first trial in children with PTHS were safety, tolerability and pharmacokinetics. Secondary endpoints included four efficacy measures specifically designed for PTHS assessed by clinicians and by caregivers, as well as ten efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. NNZ-2591 was well tolerated and demonstrated a good safety profile. All Treatment Emergent Adverse Events (TEAEs) were mild to moderate and most were considered not related to study drug. There were no Serious TEAEs and no meaningful trends in laboratory values, electrocardiogram (ECG) or other safety parameters were observed during treatment. 11 subjects completed the trial. One subject discontinued because they were unable to complete the safety monitoring procedures required by the study protocol. Four subjects discontinued due to TEAEs, all of which resolved. For two of those subjects the TEAEs (COVID-19 and mild vomiting/diarrhea/lethargy) were considered not related to study drug and for two subjects the TEAEs (moderate constipation/self-injury/abdominal distention/fatigue and mild sleep disorder/constipation) were considered related to study drug. The mean improvement from baseline was statistically significant (Wilcoxon signed rank test p<0.05) for each of the four efficacy measures that were specifically designed for Pitt Hopkins syndrome, whether calculated for the subjects that completed the study (n=11), or including discontinued subjects (n=15). Changes from baseline were not statistically significant for the efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. The results for the global measures rated by both clinicians and caregivers showed a level of improvement considered clinically meaningful. 9 out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Improvement (CGI-I), an assessment by the clinician of the child's overall status compared with baseline. The mean CGI-I score was 2.6. Five children received a score of either 1 ("very much improved") or 2 ("much improved"). 8 out of 11 children that completed the trial showed improvement measured by the PTHS Caregiver Overall Impression of Change (CIC), an assessment by the caregiver of the child's overall status compared with baseline. The mean CIC score was 3.0. Four children received a score of 2 ("much improved"). out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Severity (CGI-S), an assessment by the clinician of the child's overall severity of illness, compared with the assessment at baseline. The CGI-S score improved from 6 to 5 for 3 children and from 5 to 4 for 3 children. 8 out of 11 children that completed the trial showed improvement measured by the Caregiver Top 3 Concerns overall score, an individualised assessment by the caregiver of their child's most concerning symptoms. Language/Communication was the most commonly chosen concern.お知らせ • Apr 28Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024, at 14:30 E. Australia Standard Time. Location: FB Rice, Level 33 477 Collins St, Melbourne VIC 3000 Melbourne Australia Agenda: To receive and consider the annual report of the Company; to Re-Election of Patrick Davies as a Director; to consider Auditor Fees and Expenses.お知らせ • Feb 29Neuren Pharmaceuticals Limited to Report Q4, 2023 Results on Feb 29, 2024Neuren Pharmaceuticals Limited announced that they will report Q4, 2023 results on Feb 29, 2024最新情報をもっと見るRecent updatesお知らせ • Apr 25Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026. Location: racv city club, level 2, bayside 4a/b, 501 bourke st, melbourne vic 3000 Australiaお知らせ • Apr 24Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025. Location: the event centre, level 5, tower 2, 727 collins st, melbourne vic 3000 Australiaお知らせ • Feb 27Neuren Pharmaceuticals Limited to Report Fiscal Year 2024 Results on Feb 28, 2025Neuren Pharmaceuticals Limited announced that they will report fiscal year 2024 results on Feb 28, 2025お知らせ • May 28Neuren Phase 2 Trial Shows Significant Improvements in Pitt Hopkins SyndromeNeuren Pharmaceuticals announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Statistically significant improvement from baseline was observed by both clinicians and caregivers from treatment, across all 4 efficacy measures that were specifically designed to assess the core characteristics of PTHS. There are no approved treatments for PTHS despite its severely debilitating impact on the lives of patients, as well as their parents and siblings. The open label Phase 2 trial in 16 children aged 3 to 17 years (mean age 9 years) at five hospitals in the United States examined safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591. NNZ-2591 was administered to all subjects as an oral liquid dose twice daily, with escalation in two stages up to the target dose of 12 mg/kg during the first 6 weeks of treatment, subject to independent review of safety and tolerability data. The study commenced with at least 4 weeks of screening and observation to thoroughly define baseline characteristics prior to treatment, followed by the treatment period of 13 weeks. A follow-up assessment was made 2 weeks after the end of treatment. The primary endpoints of this first trial in children with PTHS were safety, tolerability and pharmacokinetics. Secondary endpoints included four efficacy measures specifically designed for PTHS assessed by clinicians and by caregivers, as well as ten efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. NNZ-2591 was well tolerated and demonstrated a good safety profile. All Treatment Emergent Adverse Events (TEAEs) were mild to moderate and most were considered not related to study drug. There were no Serious TEAEs and no meaningful trends in laboratory values, electrocardiogram (ECG) or other safety parameters were observed during treatment. 11 subjects completed the trial. One subject discontinued because they were unable to complete the safety monitoring procedures required by the study protocol. Four subjects discontinued due to TEAEs, all of which resolved. For two of those subjects the TEAEs (COVID-19 and mild vomiting/diarrhea/lethargy) were considered not related to study drug and for two subjects the TEAEs (moderate constipation/self-injury/abdominal distention/fatigue and mild sleep disorder/constipation) were considered related to study drug. The mean improvement from baseline was statistically significant (Wilcoxon signed rank test p<0.05) for each of the four efficacy measures that were specifically designed for Pitt Hopkins syndrome, whether calculated for the subjects that completed the study (n=11), or including discontinued subjects (n=15). Changes from baseline were not statistically significant for the efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. The results for the global measures rated by both clinicians and caregivers showed a level of improvement considered clinically meaningful. 9 out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Improvement (CGI-I), an assessment by the clinician of the child's overall status compared with baseline. The mean CGI-I score was 2.6. Five children received a score of either 1 ("very much improved") or 2 ("much improved"). 8 out of 11 children that completed the trial showed improvement measured by the PTHS Caregiver Overall Impression of Change (CIC), an assessment by the caregiver of the child's overall status compared with baseline. The mean CIC score was 3.0. Four children received a score of 2 ("much improved"). out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Severity (CGI-S), an assessment by the clinician of the child's overall severity of illness, compared with the assessment at baseline. The CGI-S score improved from 6 to 5 for 3 children and from 5 to 4 for 3 children. 8 out of 11 children that completed the trial showed improvement measured by the Caregiver Top 3 Concerns overall score, an individualised assessment by the caregiver of their child's most concerning symptoms. Language/Communication was the most commonly chosen concern.お知らせ • Apr 28Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024, at 14:30 E. Australia Standard Time. Location: FB Rice, Level 33 477 Collins St, Melbourne VIC 3000 Melbourne Australia Agenda: To receive and consider the annual report of the Company; to Re-Election of Patrick Davies as a Director; to consider Auditor Fees and Expenses.お知らせ • Feb 29Neuren Pharmaceuticals Limited to Report Q4, 2023 Results on Feb 29, 2024Neuren Pharmaceuticals Limited announced that they will report Q4, 2023 results on Feb 29, 2024お知らせ • Aug 28Neuren Pharmaceuticals Limited Reiterates Net Sales Guidance for the Third Quarter of 2023Neuren Pharmaceuticals Limited reiterate net sales guidance for the third quarter of 2023. The company is reiterating net sales guidance for Third Quarter 2023 of USD 45 to USD 55 million.お知らせ • Aug 25Neuren Pharmaceuticals Limited to Report First Half, 2023 Results on Aug 28, 2023Neuren Pharmaceuticals Limited announced that they will report first half, 2023 results on Aug 28, 2023お知らせ • Jan 23Neuren Pharmaceuticals Limited Announces Prader-Willi Syndrome IND for NNZ-2591 Approval by FDANeuren Pharmaceuticals Limited announced that the US Food and Drug Administration (FDA) has reviewed Neuren's Investigational New Drug (IND) application for NNZ-2591 in Prader-Willi syndrome (PWS) and given approval for Neuren to proceed with the planned Phase 2 clinical trial in children with PWS. Neuren is developing NNZ-2591 for four serious neurological disorders that emerge in early childhood. Phase 2 trials are currently ongoing in children with each of Angelman, Phelan-McDermid and Pitt Hopkins syndromes, for which there are no approved medicines. All four programs have been granted Orphan Drug designation by the FDA. Neuren previously reported positive results in the Magel2-null mouse model of Prader-Willi syndrome, in which treatment with NNZ-2591 for 6 weeks normalized fat mass, insulin levels, IGF-1 levels and all behavioural deficits.お知らせ • Sep 23Neuren Pharmaceuticals Limited Initiates Manufacture of Nnz-2591 for Phase 2 TrialsNeuren Pharmaceuticals Limited has initiated the manufacture of NNZ-2591 to supply the planned Phase 2 clinical trials. The contract manufacturer that supplied drug substance for the ongoing Phase 1 trial will carry out this larger scale manufacturing campaign. Neuren plans to commence Phase 2 trials in patients with each of Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome in 2021. Neuren has received Orphan Drug esignation from the FDA for NNZ-2591 to treat all three of these debilitating disorders that currently have no approved medicines.お知らせ • Aug 06Neuren Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 0.215561 million.Neuren Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 0.215561 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 153,972 Price\Range: AUD 1.4お知らせ • Jul 08Neuren Pharmaceuticals Limited announced that it has received AUD 20.000012 million in fundingOn July 6, 2020, Neuren Pharmaceuticals Limited (ASX:NEU) closed the transaction. The company issued 14,285,723 shares for gross proceeds of AUD 20,000,012.2 in the transaction.お知らせ • Jun 30Neuren Pharmaceuticals Limited announced that it expects to receive AUD 20 million in fundingNeuren Pharmaceuticals Limited (ASX:NEU) announced a private placement of 14,285,714 common shares at AUD 1.40 per share for gross proceeds of AUD 20,000,000 on June 29, 2020. The transaction will include participation from institutional and sophisticated investors in Australia, New Zealand, Hong Kong and the United Kingdom. The company expects to close the transaction on July 6, 2020.株主還元NURP.FUS PharmaceuticalsUS 市場7D0%3.6%1.3%1Y8.6%43.9%27.7%株主還元を見る業界別リターン: NURP.F過去 1 年間で43.9 % の収益を上げたUS Pharmaceuticals業界を下回りました。リターン対市場: NURP.Fは、過去 1 年間で27.7 % のリターンを上げたUS市場を下回りました。価格変動Is NURP.F's price volatile compared to industry and market?NURP.F volatilityNURP.F Average Weekly Movementn/aPharmaceuticals Industry Average Movement9.9%Market Average Movement7.2%10% most volatile stocks in US Market16.6%10% least volatile stocks in US Market3.0%安定した株価: NURP.Fの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のNURP.Fのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト2001n/aJon Pilcherwww.neurenpharma.comニューレン・ファーマシューティカルズ・リミテッド（Neuren Pharmaceuticals Limited）はバイオ医薬品会社で、神経疾患治療薬の開発を行っている。成人および2歳以上の小児におけるレット症候群の治療薬としてDAYBUE（トロフィネチド）を開発・商品化しているほか、フラジャイルX症候群の治療薬として第2相臨床試験を実施中。また、NNZ-2591の開発も行っており、フェラン・マクダーミドの治療薬として第2相臨床試験を完了し、アンジェルマンとピット・ホプキンスの治療薬として第2相臨床試験中である。さらに、プラダー・ウィリー症候群の治療薬として前臨床試験段階にあるNNZ-2591も開発している。同社は2001年に設立され、オーストラリアのキャンバーウェルに本社を置いている。もっと見るNeuren Pharmaceuticals Limited 基礎のまとめNeuren Pharmaceuticals の収益と売上を時価総額と比較するとどうか。NURP.F 基礎統計学時価総額US$1.25b収益（TTM）US$21.73m売上高(TTM)US$46.16m57.4xPER（株価収益率27.0xP/SレシオNURP.F は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計NURP.F 損益計算書（TTM）収益AU$64.65m売上原価AU$36.39m売上総利益AU$28.26mその他の費用-AU$2.18m収益AU$30.44m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）0.24グロス・マージン43.71%純利益率47.08%有利子負債／自己資本比率0%NURP.F の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/28 05:31終値2026/05/11 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Neuren Pharmaceuticals Limited 6 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。10 アナリスト機関Melissa BensonBarrenjoey Markets Pty LimitedThomas WakimBell PotterElyse ShapiroCanaccord Genuity7 その他のアナリストを表示
お知らせ • Apr 25Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026. Location: racv city club, level 2, bayside 4a/b, 501 bourke st, melbourne vic 3000 Australia
お知らせ • Apr 24Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025. Location: the event centre, level 5, tower 2, 727 collins st, melbourne vic 3000 Australia
お知らせ • Feb 27Neuren Pharmaceuticals Limited to Report Fiscal Year 2024 Results on Feb 28, 2025Neuren Pharmaceuticals Limited announced that they will report fiscal year 2024 results on Feb 28, 2025
お知らせ • May 28Neuren Phase 2 Trial Shows Significant Improvements in Pitt Hopkins SyndromeNeuren Pharmaceuticals announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Statistically significant improvement from baseline was observed by both clinicians and caregivers from treatment, across all 4 efficacy measures that were specifically designed to assess the core characteristics of PTHS. There are no approved treatments for PTHS despite its severely debilitating impact on the lives of patients, as well as their parents and siblings. The open label Phase 2 trial in 16 children aged 3 to 17 years (mean age 9 years) at five hospitals in the United States examined safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591. NNZ-2591 was administered to all subjects as an oral liquid dose twice daily, with escalation in two stages up to the target dose of 12 mg/kg during the first 6 weeks of treatment, subject to independent review of safety and tolerability data. The study commenced with at least 4 weeks of screening and observation to thoroughly define baseline characteristics prior to treatment, followed by the treatment period of 13 weeks. A follow-up assessment was made 2 weeks after the end of treatment. The primary endpoints of this first trial in children with PTHS were safety, tolerability and pharmacokinetics. Secondary endpoints included four efficacy measures specifically designed for PTHS assessed by clinicians and by caregivers, as well as ten efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. NNZ-2591 was well tolerated and demonstrated a good safety profile. All Treatment Emergent Adverse Events (TEAEs) were mild to moderate and most were considered not related to study drug. There were no Serious TEAEs and no meaningful trends in laboratory values, electrocardiogram (ECG) or other safety parameters were observed during treatment. 11 subjects completed the trial. One subject discontinued because they were unable to complete the safety monitoring procedures required by the study protocol. Four subjects discontinued due to TEAEs, all of which resolved. For two of those subjects the TEAEs (COVID-19 and mild vomiting/diarrhea/lethargy) were considered not related to study drug and for two subjects the TEAEs (moderate constipation/self-injury/abdominal distention/fatigue and mild sleep disorder/constipation) were considered related to study drug. The mean improvement from baseline was statistically significant (Wilcoxon signed rank test p<0.05) for each of the four efficacy measures that were specifically designed for Pitt Hopkins syndrome, whether calculated for the subjects that completed the study (n=11), or including discontinued subjects (n=15). Changes from baseline were not statistically significant for the efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. The results for the global measures rated by both clinicians and caregivers showed a level of improvement considered clinically meaningful. 9 out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Improvement (CGI-I), an assessment by the clinician of the child's overall status compared with baseline. The mean CGI-I score was 2.6. Five children received a score of either 1 ("very much improved") or 2 ("much improved"). 8 out of 11 children that completed the trial showed improvement measured by the PTHS Caregiver Overall Impression of Change (CIC), an assessment by the caregiver of the child's overall status compared with baseline. The mean CIC score was 3.0. Four children received a score of 2 ("much improved"). out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Severity (CGI-S), an assessment by the clinician of the child's overall severity of illness, compared with the assessment at baseline. The CGI-S score improved from 6 to 5 for 3 children and from 5 to 4 for 3 children. 8 out of 11 children that completed the trial showed improvement measured by the Caregiver Top 3 Concerns overall score, an individualised assessment by the caregiver of their child's most concerning symptoms. Language/Communication was the most commonly chosen concern.
お知らせ • Apr 28Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024, at 14:30 E. Australia Standard Time. Location: FB Rice, Level 33 477 Collins St, Melbourne VIC 3000 Melbourne Australia Agenda: To receive and consider the annual report of the Company; to Re-Election of Patrick Davies as a Director; to consider Auditor Fees and Expenses.
お知らせ • Feb 29Neuren Pharmaceuticals Limited to Report Q4, 2023 Results on Feb 29, 2024Neuren Pharmaceuticals Limited announced that they will report Q4, 2023 results on Feb 29, 2024
お知らせ • Apr 25Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2026. Location: racv city club, level 2, bayside 4a/b, 501 bourke st, melbourne vic 3000 Australia
お知らせ • Apr 24Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025Neuren Pharmaceuticals Limited, Annual General Meeting, May 27, 2025. Location: the event centre, level 5, tower 2, 727 collins st, melbourne vic 3000 Australia
お知らせ • Feb 27Neuren Pharmaceuticals Limited to Report Fiscal Year 2024 Results on Feb 28, 2025Neuren Pharmaceuticals Limited announced that they will report fiscal year 2024 results on Feb 28, 2025
お知らせ • May 28Neuren Phase 2 Trial Shows Significant Improvements in Pitt Hopkins SyndromeNeuren Pharmaceuticals announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Statistically significant improvement from baseline was observed by both clinicians and caregivers from treatment, across all 4 efficacy measures that were specifically designed to assess the core characteristics of PTHS. There are no approved treatments for PTHS despite its severely debilitating impact on the lives of patients, as well as their parents and siblings. The open label Phase 2 trial in 16 children aged 3 to 17 years (mean age 9 years) at five hospitals in the United States examined safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591. NNZ-2591 was administered to all subjects as an oral liquid dose twice daily, with escalation in two stages up to the target dose of 12 mg/kg during the first 6 weeks of treatment, subject to independent review of safety and tolerability data. The study commenced with at least 4 weeks of screening and observation to thoroughly define baseline characteristics prior to treatment, followed by the treatment period of 13 weeks. A follow-up assessment was made 2 weeks after the end of treatment. The primary endpoints of this first trial in children with PTHS were safety, tolerability and pharmacokinetics. Secondary endpoints included four efficacy measures specifically designed for PTHS assessed by clinicians and by caregivers, as well as ten efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. NNZ-2591 was well tolerated and demonstrated a good safety profile. All Treatment Emergent Adverse Events (TEAEs) were mild to moderate and most were considered not related to study drug. There were no Serious TEAEs and no meaningful trends in laboratory values, electrocardiogram (ECG) or other safety parameters were observed during treatment. 11 subjects completed the trial. One subject discontinued because they were unable to complete the safety monitoring procedures required by the study protocol. Four subjects discontinued due to TEAEs, all of which resolved. For two of those subjects the TEAEs (COVID-19 and mild vomiting/diarrhea/lethargy) were considered not related to study drug and for two subjects the TEAEs (moderate constipation/self-injury/abdominal distention/fatigue and mild sleep disorder/constipation) were considered related to study drug. The mean improvement from baseline was statistically significant (Wilcoxon signed rank test p<0.05) for each of the four efficacy measures that were specifically designed for Pitt Hopkins syndrome, whether calculated for the subjects that completed the study (n=11), or including discontinued subjects (n=15). Changes from baseline were not statistically significant for the efficacy measures that were not designed for use in PTHS but have been used in other neurodevelopmental conditions. The results for the global measures rated by both clinicians and caregivers showed a level of improvement considered clinically meaningful. 9 out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Improvement (CGI-I), an assessment by the clinician of the child's overall status compared with baseline. The mean CGI-I score was 2.6. Five children received a score of either 1 ("very much improved") or 2 ("much improved"). 8 out of 11 children that completed the trial showed improvement measured by the PTHS Caregiver Overall Impression of Change (CIC), an assessment by the caregiver of the child's overall status compared with baseline. The mean CIC score was 3.0. Four children received a score of 2 ("much improved"). out of 11 children that completed the trial showed improvement measured by the PTHS Clinical Global Impression of Severity (CGI-S), an assessment by the clinician of the child's overall severity of illness, compared with the assessment at baseline. The CGI-S score improved from 6 to 5 for 3 children and from 5 to 4 for 3 children. 8 out of 11 children that completed the trial showed improvement measured by the Caregiver Top 3 Concerns overall score, an individualised assessment by the caregiver of their child's most concerning symptoms. Language/Communication was the most commonly chosen concern.
お知らせ • Apr 28Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024Neuren Pharmaceuticals Limited, Annual General Meeting, May 28, 2024, at 14:30 E. Australia Standard Time. Location: FB Rice, Level 33 477 Collins St, Melbourne VIC 3000 Melbourne Australia Agenda: To receive and consider the annual report of the Company; to Re-Election of Patrick Davies as a Director; to consider Auditor Fees and Expenses.
お知らせ • Feb 29Neuren Pharmaceuticals Limited to Report Q4, 2023 Results on Feb 29, 2024Neuren Pharmaceuticals Limited announced that they will report Q4, 2023 results on Feb 29, 2024
お知らせ • Aug 28Neuren Pharmaceuticals Limited Reiterates Net Sales Guidance for the Third Quarter of 2023Neuren Pharmaceuticals Limited reiterate net sales guidance for the third quarter of 2023. The company is reiterating net sales guidance for Third Quarter 2023 of USD 45 to USD 55 million.
お知らせ • Aug 25Neuren Pharmaceuticals Limited to Report First Half, 2023 Results on Aug 28, 2023Neuren Pharmaceuticals Limited announced that they will report first half, 2023 results on Aug 28, 2023
お知らせ • Jan 23Neuren Pharmaceuticals Limited Announces Prader-Willi Syndrome IND for NNZ-2591 Approval by FDANeuren Pharmaceuticals Limited announced that the US Food and Drug Administration (FDA) has reviewed Neuren's Investigational New Drug (IND) application for NNZ-2591 in Prader-Willi syndrome (PWS) and given approval for Neuren to proceed with the planned Phase 2 clinical trial in children with PWS. Neuren is developing NNZ-2591 for four serious neurological disorders that emerge in early childhood. Phase 2 trials are currently ongoing in children with each of Angelman, Phelan-McDermid and Pitt Hopkins syndromes, for which there are no approved medicines. All four programs have been granted Orphan Drug designation by the FDA. Neuren previously reported positive results in the Magel2-null mouse model of Prader-Willi syndrome, in which treatment with NNZ-2591 for 6 weeks normalized fat mass, insulin levels, IGF-1 levels and all behavioural deficits.
お知らせ • Sep 23Neuren Pharmaceuticals Limited Initiates Manufacture of Nnz-2591 for Phase 2 TrialsNeuren Pharmaceuticals Limited has initiated the manufacture of NNZ-2591 to supply the planned Phase 2 clinical trials. The contract manufacturer that supplied drug substance for the ongoing Phase 1 trial will carry out this larger scale manufacturing campaign. Neuren plans to commence Phase 2 trials in patients with each of Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome in 2021. Neuren has received Orphan Drug esignation from the FDA for NNZ-2591 to treat all three of these debilitating disorders that currently have no approved medicines.
お知らせ • Aug 06Neuren Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 0.215561 million.Neuren Pharmaceuticals Limited has completed a Follow-on Equity Offering in the amount of AUD 0.215561 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 153,972 Price\Range: AUD 1.4
お知らせ • Jul 08Neuren Pharmaceuticals Limited announced that it has received AUD 20.000012 million in fundingOn July 6, 2020, Neuren Pharmaceuticals Limited (ASX:NEU) closed the transaction. The company issued 14,285,723 shares for gross proceeds of AUD 20,000,012.2 in the transaction.
お知らせ • Jun 30Neuren Pharmaceuticals Limited announced that it expects to receive AUD 20 million in fundingNeuren Pharmaceuticals Limited (ASX:NEU) announced a private placement of 14,285,714 common shares at AUD 1.40 per share for gross proceeds of AUD 20,000,000 on June 29, 2020. The transaction will include participation from institutional and sophisticated investors in Australia, New Zealand, Hong Kong and the United Kingdom. The company expects to close the transaction on July 6, 2020.
