Axsome Therapeutics举办脑健康研发前沿日，回顾行业领先的晚期中枢神经系统管线-动脉网

Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline

Axsome Therapeutics 等信源发布 2025-07-21 20:17



可切换为仅中文







Download PDF

下载PDF

Comprehensive review of broad pipeline targeting Alzheimer’s disease agitation, depression, narcolepsy, fibromyalgia, ADHD, and smoking cessation, with new data analyses

针对阿尔茨海默病躁动、抑郁、嗜睡症、纤维肌痛、注意力缺陷多动障碍（ADHD）及戒烟的广泛研究管线的全面回顾，并包含新的数据分析

Presentations by expert clinicians and key opinion leaders

专家临床医生和关键意见领袖的演讲

Company to webcast its R&D Day event today at

公司今天将网络直播其研发日活动

11:00 AM

上午11:00

Eastern

东方的

NEW YORK

纽约

，

July 21, 2025

2025年7月21日

(GLOBE NEWSWIRE) --

（环球新闻网）--

Axsome Therapeutics, Inc.

(NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, will host its Frontiers in Brain Health R&D Day today in

(NASDAQ: AXSM)，一家引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司，将于今天举办其大脑健康研发前沿日活动。

New York City

纽约市

to review its industry-leading CNS pipeline.

审查其行业领先的CNS产品线。

The Frontiers in Brain Health R&D Day will feature presentations from the following six leading expert clinicians and key opinion leaders, who will discuss the psychiatric and neurological conditions targeted by the company’s pipeline, and present clinical data from the pipeline programs:

脑健康研发前沿日将邀请以下六位临床专家和关键意见领袖发表演讲，他们将讨论公司研发管线所针对的精神病学和神经学疾病，并介绍这些研发项目中的临床数据：

Andrea Chadwick

安德烈亚·查德威克

, MD, MSc, FASA,

，医学博士，理学硕士，FASA，

Kasumi Arakawa Professor

荒川霞教授

of Anesthesiology, Pain, and Perioperative Medicine and Director of the

麻醉学、疼痛与围手术期医学部主任及

Fibromyalgia and Centralized Pain Exploration (FACE) Lab

纤维肌痛与中枢性疼痛探索（FACE）实验室

;

；

University of Kansas Medical Center

堪萨斯大学医学中心

。

Dr. Chadwick

查德威克博士

will provide an overview of fibromyalgia and of the previously completed Phase 2 and Phase 3 clinical trials of AXS-14 in the indication.

将概述纤维肌痛症以及AXS-14在此适应症中先前完成的2期和3期临床试验。

Jeffrey Cummings

杰弗里·卡明斯

, MD, ScD,

医学博士，理学博士，

Joy Chambers-Grundy Professor

乔伊·钱伯斯-格伦迪教授

of Brain Science, Chair of the

大脑科学系主任

Chambers-Grundy Center for Transformative Neuroscience

钱伯斯-格伦迪转化神经科学中心

, and Clinical Professor Neurology,

，临床神经病学教授，

UNLV Department of Brain Health

联合国拉斯维加斯分校脑健康系

。

Dr. Cummings

库明斯博士

will provide an overview of Alzheimer's disease (AD) agitation and discuss the results of the ADVANCE and ACCORD Phase 3 trials of AXS-05 in the indication.

将概述阿尔茨海默病（AD）的躁动症状，并讨论AXS-05在ADVANCE和ACCORD第三阶段试验中的结果。

Andrew Cutler

安德鲁·卡特勒

, MD,

，医学博士，

Clinical Associate Professor of Psychiatry,

精神病学临床副教授，

SUNY Upstate Medical University

纽约州立大学上州医科大学

。

Dr Cutler

卡特勒博士

will provide an overview of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), and excessive sleepiness associated with shift work disorder (SWD), and discuss the results of the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and MDD, respectively..

将概述注意力缺陷多动障碍 (ADHD)、伴有过度日间嗜睡 (EDS) 的重度抑郁症 (MDD) 以及与轮班工作障碍 (SWD) 相关的过度嗜睡，并讨论 solriamfetol 在 ADHD 和 MDD 中的 FOCUS 和 PARADIGM 第三期试验结果。

Susan McElroy

苏珊·麦克尔罗伊

, MD,

，医学博士，

Professor of Psychiatry & Behavioral Neuroscience and Chief Research Officer and Director of

精神病学与行为神经科学教授，首席研究官及主任

Psychopharmacology Research

心理药理学研究

at the

在

Lindner Center of HOPE

希望林德纳中心

，

University of Cincinnati

辛辛那提大学

。

Dr. McElroy

麦克尔罗伊博士

will provide an overview of binge eating disorder (BED).

将提供暴食症（BED）的概述。

Stewart J. Tepper

斯图尔特·J·泰珀

, MD,

，医学博士，

Vice President at

副总裁 tại

The New England Institute for Neurology and Headache

新英格兰神经病学与头痛研究所

and Professor Neurology,

神经病学教授，

Geisel School of Medicine

盖泽尔医学院

at Dartmouth.

达特茅斯学院。

Dr. Tepper

特珀博士

will provide an overview of migraine and will discuss results from the MOMENTUM and INTERCEPT Phase 3 trials of SYMBRAVO

将提供偏头痛的概述，并讨论SYMBRAVO在MOMENTUM和INTERCEPT第三阶段试验的结果。

in the acute treatment of migraine with and without aura.

在有或无先兆的偏头痛急性治疗中。

Michael Thorpy

迈克尔·索普

, MD,

，医学博士，

Professor of Neurology and Director of the Sleep-Wake Disorders Center at the

神经病学教授，睡眠觉醒障碍中心主任

Montefiore Medical Center

蒙特菲奥里医疗中心

，

Albert Einstein College of Medicine

阿尔伯特·爱因斯坦医学院

。

Dr. Thorpy

托普医生

will provide an overview of narcolepsy and will discuss the results of the clinical trial program of AXS-12 in the indication.

将提供嗜睡症的概述，并讨论AXS-12在该适应症中的临床试验计划的结果。

The presenters and the management team will be available to answer questions at the end of the presentations. To access the event, please click

演讲者和管理团队将在演讲结束后回答问题。要参加此次活动，请点击

here

这里

。

Webcast Information

网络直播信息

This event is intended for institutional investors and sell-side analysts. To register for the live webcast, please click

该活动面向机构投资者和卖方分析师。要注册现场网络直播，请点击

here

这里

. The live webcast and a replay of the event will also be publicly available on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at

公司的网站上“投资者”部分的“网络直播和演示”页面也将公开提供活动的现场直播和重播。

www.axsome.com

。

About

关于

Axsome Therapeutics

is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes.

是一家引领中枢神经系统 (CNS) 疾病治疗新时代的生物制药公司。我们通过识别护理中的关键差距来实现科学突破，并专注于新的作用机制，开发差异化产品，从而在患者治疗效果上实现有意义的进步。

Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in .

我们行业领先的神经科学产品组合包括FDA批准的治疗重度抑郁症、与嗜睡症和阻塞性睡眠呼吸暂停相关的白天过度嗜睡以及偏头痛的药物，并且有多个后期开发项目，针对影响超过1.5亿人的各种严重的神经和精神疾病。

the United States

美国

. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at

。我们共同肩负着解决大脑一些最重大问题的使命，让患者及其亲人能够茁壮成长。欲了解更多信息，请访问我们的网站

www.axsome.com

and follow us on

关注我们

领英

and

和

。

Forward Looking Statements

前瞻性声明

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

本新闻稿中讨论的某些事项属于“前瞻性陈述”。公司在某些情况下可能会使用“预测”、“相信”、“潜在”、“继续”、“估计”、“预期”、“计划”、“意图”、“可能”、“能够”、“也许”、“将”、“应该”等词语来表达未来事件或结果的不确定性，以识别这些前瞻性陈述。

In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI.

特别是，公司关于趋势和潜在未来结果的声明是此类前瞻性陈述的例子。前瞻性陈述包含风险和不确定性，包括但不限于公司SUNOSI的商业成功。

, AUVELITY

，AUVELITY

, and SYMBRAVO

，以及SYMBRAVO

products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain .

产品以及公司为solriamfetol和/或AXS-05获得任何额外适应症的努力的成功；公司维持和扩大支付方覆盖的能力；公司正在进行的临床试验及预计的临床试验的成功、时间安排和成本，针对公司现有候选产品的试验，包括关于试验启动时间、入组速度和完成情况的声明（包括公司全额资助其已披露临床试验的能力，前提是公司目前预期的收入或支出没有重大变化）、无效性分析及中期结果的获取，这些结果并不一定反映公司正在进行的临床试验的最终结果，和/或数据读数，以及支持公司现有候选产品中新药申请（“NDA”）所需的研究数量或类型或结果性质；公司为继续推进候选产品而资助额外临床试验的能力；公司获得和维持的时间和能力。

U.S. Food and Drug Administration

美国食品药品监督管理局

(“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control.

美国食品药品监督管理局（“FDA”）或其他监管机构对公司产品候选物的批准或其他相关行动，包括任何新药申请（NDA）提交时间的声明；公司成功捍卫其知识产权或以公司可接受的成本获得必要许可的能力（如果可能的话）；公司成功解决任何知识产权诉讼的能力，即使这些争议得以解决，相关联邦机构是否会批准此类和解；公司研究与开发计划及合作的成功实施；公司许可协议的成功执行；市场对公司产品及其候选产品的接受度（如获批准）；公司预期的资本需求，包括用于SUNOSI、AUVELITY和SYMBRAVO商业化以及公司其他候选产品商业化推出（如获批准）所需的资本金额，以及对公司预期现金跑道的潜在影响；公司将销售额转化为确认收入并保持有利的总对净销售比率的能力；因国内政治气候、地缘政治冲突或全球疫情而引起或相关的不可预见情况或其他对正常业务运营的干扰，以及其他因素，包括一般经济状况和不在公司控制范围内的监管发展。

The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking sta.

本文讨论的因素可能导致实际结果和发展与这些陈述中表达或暗示的内容有重大差异。前瞻性陈述仅在本新闻稿发布之日作出，公司不承担公开更新此类前瞻性陈述的义务。

Investors:

投资者：

Mark Jacobson

马克·雅各布森

Chief Operating Officer

首席运营官

(212) 332-3243

mjacobson@axsome.com

Media:

媒体：

Darren Opland