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NEW YORK

纽约

,

，

May 28, 2025

2025年5月28日

(GLOBE NEWSWIRE) --

（环球新闻网）--

Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc.

(NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations from three of its innovative neuroscience programs at the

(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，今天宣布了其三个创新神经科学项目在会议上的展示。

American Society of Clinical Psychopharmacology

美国临床精神药理学会

(ASCP) 2025 Annual Meeting, being held from

(ASCP) 2025年年会，将于

May 27-30

5月27日至30日

in

在

Scottsdale, Arizona

亚利桑那州斯科茨代尔

.

。

Details of the presentations are as follows:

演示文稿的详细信息如下：

AUVELITY

奥维利蒂

Title

标题

: Initiating Dextromethorphan 45 mg - Bupropion 105 mg (AUVELITY

：开始使用右美沙芬45毫克-安非他酮105毫克（AUVELITY）

®

®

) in Patients with Major Depressive Disorder (MDD): Expert Panel Consensus Recommendations

重度抑郁症（MDD）患者的治疗：专家小组共识建议

Lead Author:

主要作者：

Anita Clayton

阿妮塔·克莱顿

, MD,

，医学博士，

Wilford W. Spradlin Professor

威尔福德·W·斯普拉德林教授

and Chair of Psychiatry & Neurobehavioral Sciences and Professor of Clinical Obstetrics & Gynecology at the

精神病学与神经行为科学系主任，临床妇产科教授

University of Virginia

弗吉尼亚大学

Presentation Date and Time:

演示日期和时间：

Wednesday, May 28

5月28日，星期三

, 11:15 a.m. - 1 p.m. Mountain Standard Time

，上午11点15分至下午1点，山区标准时间

Session

会话

Name

名字

:

：

Poster Session I

海报会议 I

Poster Number:

海报编号：

W25

W25

AXS-05

AXS-05

Title:

标题：

Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized-Withdrawal Double-Blind Placebo-Controlled Study

AXS-05治疗阿尔茨海默病躁动的疗效与安全性：一项三期随机撤药双盲安慰剂对照研究

Lead Author:

主要作者：

Jeffrey Cummings

杰弗里·卡明斯

, MD, ScD, Vice Chair of Research,

医学博士，理学博士，研究副主席，

UNLV Department of Brain Health

UNLV大脑健康系

Presentation Date and Time:

演示日期和时间：

Thursday, May 29

5月29日，星期四

, 11:30 a.m. - 1 p.m. Mountain Standard Time

，上午11点30分至下午1点（山区标准时间）

Session

会话

Name

名称

:

：

Poster Session II

海报会议 II

Poster Number:

海报编号：

T16

T16

Solriamfetol

索利氨非托尔

Title:

标题：

Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY Study

在真实世界SURWEY研究中，使用Solriamfetol治疗伴有焦虑和抑郁的嗜睡症及OSA患者的白天过度嗜睡

Lead Author:

主要作者：

Ulf Kallweit

乌尔夫·卡尔斯维特

, MD, Assistant Professor of Neurology at

医学博士，神经学助理教授于

Witten/Herdecke University

维滕/黑尔德克大学

,

，

Germany

德国

Presentation Date and Time:

演示日期和时间：

Thursday, May 29

5月29日，星期四

, 11:30 a.m. - 1 p.m. Mountain Standard Time

，上午11点30分至下午1点，山区标准时间

Session

会话

Name

名称

:

：

Poster Session II

海报会议 II

Poster Number:

海报编号：

T15

T15

About AUVELITY

关于AUVELITY

®

®

AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist.

AUVELITY 是一种新型的、口服的、具有多模式活性的 NMDA 受体拮抗剂，被批准用于治疗成人重度抑郁症 (MDD)。AUVELITY 是一种专利缓释口服片剂，含有氢溴酸右美沙芬 (45 毫克) 和盐酸安非他酮 (105 毫克)。AUVELITY 的右美沙芬成分是 NMDA 受体（一种离子型谷氨酸受体）的拮抗剂，也是 sigma-1 受体的激动剂。

These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of AUVELITY in the treatment of depression is unclear.

这些作用被认为可以调节谷氨酸能神经传递。AUVELITY 的安非他酮成分是一种氨基酮和 CYP2D6 抑制剂，可增加和延长右美沙芬的血药浓度。AUVELITY 治疗抑郁症的确切作用机制尚不清楚。

AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD..

AUVELITY获得了FDA授予的治疗MDD的突破性疗法认定。

INDICATION AND IMPORTANT SAFETY INFORMATION

适应症和重要安全信息

WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if AUVELITY is safe and effective for use in children.

什么是AUVELITY（aw-VEHL-ah-tee）？它是一种用于治疗成人重度抑郁症（MDD）的处方口服药物。目前尚不清楚AUVELITY在儿童中的使用是否安全有效。

AUVELITY is not approved for uses other than the treatment of MDD. The ingredients in AUVELITY, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses.

AUVELITY未被批准用于治疗MDD以外的其他用途。AUVELITY中的成分安非他酮和右美沙芬，与某些其他药物中所含的成分相同，而那些药物已被批准用于其他用途。

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY?

我应该了解的关于AUVELITY的最重要的信息是什么？

AUVELITY and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children.

AUVELITY和其他抗抑郁药物可能会增加某些儿童、青少年和年轻成人中的自杀念头和行为，尤其是在治疗的最初几个月或剂量调整时。AUVELITY不适用于儿童。

You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine.

您应该密切关注情绪、行为、思想或感觉的任何新的或突然的变化，或者是否出现自杀念头或行为。在开始服用或调整抗抑郁药物剂量时，这一点尤为重要。

Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you:

如果您或您的亲人出现以下任何症状，请立即致电您的医疗服务提供者 (HCP) 或寻求紧急帮助，特别是如果这些症状是新的、加重的或让您担忧时：

suicidal thoughts or actions

自杀念头或行为

new or worsening depression or anxiety

新的或恶化的抑郁或焦虑

agitation or restlessness

焦虑或不安

trouble sleeping (insomnia)

睡眠困难（失眠）

acting aggressive, being angry violent

表现得咄咄逼人，愤怒暴力

an extreme increase in activity and talking (mania)

极端的活动和说话增加（躁狂）

panic attacks

惊恐发作

new or worsening irritability

新的或恶化的易怒性

acting on dangerous impulses

行动受危险冲动驱使

other unusual changes in behavior or mood

其他行为或情绪的异常变化

Do not take AUVELITY if you:

如果您有以下情况，请勿服用AUVELITY：

have or had a seizure disorder.

有或曾有癫痫发作障碍。

have or had an eating disorder like anorexia or bulimia.

患有或曾经患有像厌食症或暴食症这样的饮食失调症。

have recently and suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and you have recently suddenly stopped taking them.

最近突然停止饮酒或使用称为苯二氮卓类、巴比妥类或抗癫痫药物，并且您最近突然停止服用它们。

are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in the last 14 days, or are being treated with the antibiotic linezolid or intravenous methylene blue. Ask your HCP or pharmacist if you are unsure whether you take an MAOI. Do not start taking an MAOI until you have stopped taking AUVELITY for at least 14 days..

正在服用单胺氧化酶抑制剂 (MAOI)，在过去的 14 天内已停止服用 MAOI，或正在接受抗生素利奈唑胺或静脉注射亚甲蓝治疗。如果您不确定是否服用 MAOI，请咨询您的医疗保健提供者或药剂师。在您停止服用 AUVELITY 至少 14 天之前，请勿开始服用 MAOI。

are allergic to dextromethorphan, bupropion, or any other ingredients in AUVELITY.

对右美沙芬、安非他酮或AUVELITY中的任何其他成分过敏。

AUVELITY may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one:

AUVELITY 可能导致严重的副作用。询问您的医疗保健提供者如何识别以下严重副作用，以及如果您认为自己出现了其中之一应该怎么做：

Seizures. There is a risk of seizures during treatment with AUVELITY. The risk is higher if you take higher doses of AUVELITY, have certain medical problems, or take AUVELITY with certain other medicines. Do not take AUVELITY with other medicines unless your healthcare provider tells you to.

癫痫发作。使用AUVELITY治疗期间存在癫痫发作的风险。如果您服用较高剂量的AUVELITY、有某些健康问题或与某些其他药物一起服用AUVELITY，风险会更高。除非您的医疗保健提供者告知您，否则不要将AUVELITY与其他药物一起服用。

If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your HCP right away. Do not take AUVELITY again if you have a seizure.

如果在使用AUVELITY治疗期间出现癫痫发作，立即停止服用AUVELITY并马上联系您的医疗保健提供者。如果出现癫痫发作，请勿再次服用AUVELITY。

Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with AUVELITY. Your HCP should check your blood pressure before you start taking and during treatment with AUVELITY.

血压升高（高血压）。一些人在使用AUVELITY治疗期间可能会出现高血压。您的医疗保健提供者应在您开始服用AUVELITY之前和治疗期间检查您的血压。

Manic episodes. Manic episodes may happen in people with bipolar disorder who take AUVELITY. Symptoms may include:

躁狂发作。服用AUVELITY的双相情感障碍患者可能会出现躁狂发作。症状可能包括：

greatly increased energy

能量大大增加

racing thoughts

思绪奔腾

unusually grand ideas

异常宏大的想法

talking more or faster than usual

说话比平时多或快

severe trouble sleeping

严重睡眠困难

reckless behavior

轻率行为

excessive happiness or irritability

过度的快乐或易怒

Unusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused.

不寻常的想法或行为。AUVELITY（安非他酮）的成分之一可能导致不寻常的想法或行为，包括妄想（认为自己是其他人）、幻觉（看到或听到不存在的事物）、偏执（感觉人们都在针对你）或感到困惑。

If this happens to you, call your HCP..

如果发生这种情况，请联系你的医疗保健专业人员。

Eye problems (angle-closure glaucoma). AUVELITY may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye..

眼部问题（闭角型青光眼）。AUVELITY 可能会导致某些其他眼部状况的人出现一种称为闭角型青光眼的眼部问题。您可能需要进行眼部检查，以确定自己是否有风险，并在接受预防治疗时进行处理。如果您感到眼痛、视力发生变化或眼睛周围出现肿胀或发红，请立即联系您的医疗保健提供者。

Dizziness. AUVELITY may cause dizziness which may increase your risk for falls.

头晕。AUVELITY 可能会引起头晕，从而增加您摔倒的风险。

Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take AUVELITY with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms:

血清素综合征。 当你服用AUVELITY与某些其他药物时，可能会发生一种潜在的危及生命的问题，称为血清素综合征。 如果你有以下任何体征和症状，请立即致电你的医疗保健提供者或前往最近的医院急诊室：

agitation

焦虑

hallucinations

幻觉

confusion

混乱

coma

昏迷

fast heartbeat

心跳加速

blood pressure changes

血压变化

dizziness

头晕

sweating

出汗

flushing

冲洗

high body temperature (hyperthermia)

高体温（高热）

shaking (tremors), stiff muscles, or muscle twitching

颤抖（震颤）、肌肉僵硬或肌肉抽搐

loss of coordination

失去协调性

seizures

癫痫发作

nausea, vomiting, diarrhea

恶心、呕吐、腹泻

COMMON SIDE EFFECTS

常见副作用

The most common side effects of AUVELITY include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.

AUVELITY最常见的副作用包括头晕、头痛、腹泻、嗜睡、口干、性功能问题和过度出汗。

These are not all the possible side effects of AUVELITY. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or

这些并非 AUVELITY 的所有可能副作用。如果有任何副作用，请告知您的医生。您可以拨打 1-800-FDA-1088 报告副作用，或者访问相关网站。

www.fda.gov/medwatch

www.fda.gov/medwatch

.

。

BEFORE USING

使用前

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告诉您的医疗保健提供者您所服用的所有药物，包括处方药和非处方药、维生素以及草药补充剂。

It is important to tell your HCP if you are taking:

如果您正在服用以下药物，告知您的医疗保健专业人员非常重要：

other medicines containing bupropion or dextromethorphan

含有安非他酮或右美沙芬的其他药物

medicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants

治疗抑郁症、焦虑症、精神病或思维障碍的药物，包括选择性5-羟色胺再摄取抑制剂（SSRIs）和三环类抗抑郁药

theophylline

茶碱

corticosteroids

皮质类固醇

oral diabetes medicines or use insulin to control your blood sugar

口服糖尿病药物或使用胰岛素来控制血糖

medicines to control appetite (anorectic)

控制食欲的药物（厌食剂）

nicotine medicines to help you stop smoking

帮助您戒烟的尼古丁药物

street (illicit) drugs

街头（非法）毒品

benzodiazepines, sedative-hypnotic (sleep medicines), or opiates

苯二氮卓类药物、镇静催眠药（安眠药）或阿片类药物

If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take AUVELITY with your other medicines.

如果您不确定是否服用这些药物，请咨询您的医疗保健提供者。他们可以告诉您与其他药物一起服用AUVELITY是否安全。

Tell your HCP if you are pregnant or plan to become pregnant. AUVELITY may harm your unborn baby if you take it during pregnancy. AUVELITY is not recommended during pregnancy. Your HCP will prescribe another treatment for females who plan to become pregnant.

如果您怀孕或计划怀孕，请告知您的医疗保健提供者。在怀孕期间服用AUVELITY可能会对您的未出生婴儿造成伤害。不建议在怀孕期间使用AUVELITY。对于计划怀孕的女性，您的医疗保健提供者会开具另一种治疗方案。

One of the ingredients in AUVELITY passes into your breast milk. Do not breastfeed during treatment with AUVELITY and for 5 days after the final dose.

AUVELITY 中的一种成分会进入您的母乳。在使用 AUVELITY 治疗期间及最后一剂后的 5 天内，请勿进行母乳喂养。

Tell your HCP about all your medical conditions, including if you:

告诉你的医疗保健提供者（HCP）你的所有健康状况，包括如果你：

have problems with your liver or kidneys.

肝脏或肾脏有问题。

have diabetes, heart disease, or high blood pressure.

患有糖尿病、心脏病或高血压。

have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.

有癫痫发作、中风、饮食失调、头部受伤的历史，或者大脑或脊髓中有肿瘤。

have a history of alcohol or drug abuse.

有酗酒或药物滥用的历史。

have a history of seizure, eating disorder, or abuse alcohol or drugs.

有癫痫、饮食失调或滥用酒精和药物的历史。

have low blood sugar, low blood sodium levels, or a history of falls.

血糖低、血钠水平低或有跌倒史。

you take certain other medicines that could interact with AUVELITY.

您服用某些其他可能与AUVELITY相互作用的药物。

have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.

患有或曾患有双相情感障碍、双相情感障碍家族史、自杀或抑郁的情况。

have high pressure in the eye (glaucoma).

眼压高（青光眼）。

Review the list below with your HCP. AUVELITY may not be right for you if:

请与您的医疗保健提供者（HCP）一起查看以下列表。如果您有以下情况，AUVELITY可能不适合您：

you drink a lot of alcohol.

你喝了很多酒。

you abuse prescription or street drugs.

你滥用处方药或街头毒品。

you are pregnant or plan to become pregnant.

您怀孕或计划怀孕。

you are breastfeeding or plan to breastfeed.

您正在哺乳或计划进行哺乳。

HOW TO TAKE

如何服用

AUVELITY is available by prescription only.

AUVELITY 仅凭处方提供。

Take AUVELITY exactly as instructed by your HCP.

请严格按照您的医疗保健专业人员（HCP）的指示服用AUVELITY。

Take AUVELITY 1 time a day for 3 days, then increase your dose to 2 times a day (taken at least 8 hours apart). Do not take more than 2 AUVELITY tablets in 24 hours.

每天服用AUVELITY一次，连续服用3天，然后将剂量增加到每天两次（每次至少间隔8小时）。24小时内不要服用超过2片AUVELITY。

If you miss a dose, do not take an extra dose. Wait and take your next dose at the regular time. Do not take more than 1 dose of AUVELITY at a time.

如果漏服了一剂，不要额外服用。等待并在常规时间服用下一剂。一次不要服用超过1剂的AUVELITY。

Do not change your dose or stop taking AUVELITY without talking to your HCP.

不要在未咨询您的医疗保健提供者的情况下改变剂量或停止服用AUVELITY。

Swallow AUVELITY tablets whole. Do not crush, chew, or divide the tablets.

整片吞服AUVELITY药片。不要压碎、咀嚼或分开药片。

Do not give AUVELITY to other people.

不要将AUVELITY给其他人。

If you take too much AUVELITY call your HCP or seek medical advice promptly.

如果您服用过多的AUVELITY，请立即联系您的医疗保健提供者或寻求医疗建议。

LEARN MORE

了解更多

For more information about AUVELITY, call 866-496-2976 or visit

有关 AUVELITY 的更多信息，请拨打 866-496-2976 或访问

AUVELITY.com

奥维莱缇.com

.

。

This summary provides basic information about AUVELITY but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about AUVELITY and how to take it.

本摘要提供了关于AUVELITY的基本信息，但并未包含有关此药物的所有信息。每次配药时，请务必阅读随处方提供的信息。此信息不能替代与医生的交流。请务必与您的医生或其他医疗保健专业人员（HCP）讨论AUVELITY及其用法。

Your HCP is the best person to help you decide if AUVELITY is right for you..

您的医疗保健专业人士是最能帮助您决定 AUVELITY 是否适合您的人。

AUV CON BS 10/2022

AUV CON BS 10/2022

Please see full

请查看完整内容

Prescribing Information

处方信息

, including Boxed Warning for suicidal thoughts and behaviors, and

，包括针对自杀念头和行为的黑框警告，以及

Medication Guide

药品指南

.

。

About

关于

Axsome Therapeutics

Axsome Therapeutics

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.

Axsome Therapeutics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缺口，开发具有新颖作用机制的差异化产品，从而实现科学突破，为患者带来有意义的治疗进展。

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 the .

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过度日间嗜睡以及偏头痛的药物，并且还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。

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

。我们共同致力于解决大脑的一些最大问题，以便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

www.axsome.com

and follow us on

关注我们

LinkedIn

领英

and

和

X

X

.

。

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为“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示例。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期临床试验的成功、时间安排和成本，针对公司现有候选产品的相关声明，包括试验启动时间、入组进度和完成情况（包括公司能否全额资助其已披露的临床试验，这假设公司目前预计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/或数据读出结果，以及支持公司现有候选产品中新药申请（“NDA”）所需的研究所数量或类型或结果性质；公司为继续推进候选产品而资助其他临床试验的能力；以及公司获取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.

(“FDA”) 或其他监管机构对公司的产品候选物的批准或其他行动，包括任何新药申请（NDA）提交的时间；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产品候选物的接受度（如获批准）；公司预期的资本需求，包括用于商业化SUNOSI、AUVELITY 和 SYMBRAVO 的资金以及公司其他产品候选物商业化上市所需的资金（如获批准），以及对公司预期现金跑道的潜在影响；公司将销售转化为确认收入并保持有利的总销售额到净销售额的能力；由于国内政治气候、地缘政治冲突或全球性疫情引发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非公司可控范围内的监管发展。

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所表达或暗示的有重大不同。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

(212) 332-3243

mjacobson@axsome.com

mjacobson@axsome.com

Media:

媒体：

Darren Opland

达伦·奥普兰德

Director, Corporate Communications

企业传播总监

(929) 837-1065

(929) 837-1065

dopland@axsome.com

多普兰@阿克索姆.com

Source: Axsome Therapeutics, Inc.

来源：Axsome Therapeutics, Inc.