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Axsome obtains exclusive global rights to AZD7325, a novel oral selective GABA

Axsome 获得了 AZD7325 的全球独家权利，这是一种新型口服选择性 GABA

A

A

α2,3 receptor positive allosteric modulator

α2,3受体正向变构调节剂

Deepens Axsome’s broad and innovative neuroscience portfolio with a synergistic early-stage program for epilepsy

通过一个协同的早期癫痫项目，深化了Axsome广泛且创新的神经科学产品组合。

NEW YORK

纽约

,

，

Nov. 06, 2025

2025年11月6日

(GLOBE NEWSWIRE) --

（环球新闻社）--

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 that it has entered into an agreement to obtain exclusive global rights to AZD7325, a novel oral GABA

(NASDAQ: AXSM)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，今天宣布已达成一项协议，获得新型口服GABA药物AZD7325的全球独家权利。

A

A

receptor α2,3 subtype-selective positive allosteric modulator (PAM), licensed from

受体α2,3亚型选择性正向变构调节剂（PAM），授权自

AstraZeneca AB

阿斯利康公司

(NASDAQ: AZN). AZD7325 has completed Phase 1 trials. Axsome intends to evaluate AZD7325 as a potential treatment for epilepsy and plans to begin Phase 2 trial-enabling activities in 2026.

（纳斯达克：AZN）。AZD7325 已完成第一阶段试验。Axsome 打算评估 AZD7325 作为癫痫的潜在治疗方法，并计划在 2026 年开始第二阶段试验的相关活动。

“This transaction adds AZD7325, an earlier stage molecule with a differentiated mechanism of action, to our leading late-stage CNS portfolio,” said

“此次交易将AZD7325这一作用机制独特的早期分子加入到我们领先的后期中枢神经系统（CNS）产品组合中，”

Herriot Tabuteau

埃里奥·塔布图

, MD, Chief Executive Officer of Axsome. “We are excited to further deepen our research pipeline in a complementary way, and to extend our clinical efforts into epilepsy, an area where there is an urgent need for innovative new treatment options for patients.”

，医学博士，Axsome首席执行官。“我们很高兴能够以互补的方式进一步深化我们的研究管线，并将我们的临床工作扩展到癫痫领域，这是一个迫切需要创新治疗方案的患者群体。”

AZD7325 has demonstrated anti-convulsant effects in preclinical seizure models. In clinical studies in over 700 patients to date, AZD7325 has demonstrated a favorable safety and tolerability profile.

AZD7325在临床前癫痫模型中展示了抗惊厥作用。在迄今为止的700多名患者的临床研究中，AZD7325展现了良好的安全性和耐受性。

Axsome will receive worldwide commercial, development, and manufacturing rights to AZD7325. The transaction was effectuated through Axsome’s acquisition of a 100% equity interest in

Axsome将获得AZD7325的全球商业、开发和制造权利。该交易通过Axsome收购某公司100%的股权实现，

Baergic Bio, Inc.

贝格生物公司

, a subsidiary of

，是...的子公司

Avenue Therapeutics, Inc.

大街治疗公司

(OTC: ATXI), and concurrent amendment to the License Agreement between Baergic Bio and

(场外交易: ATXI)，以及Baergic Bio与...之间的许可协议的同步修订

AstraZeneca

阿斯利康

. Under the terms of the Baergic Bio Share Purchase Agreement, Baergic Bio shareholders will receive a

根据《Baergic Bio股份购买协议》的条款，Baergic Bio的股东将获得

$0.3 million

30万美元

upfront payment and are eligible to receive development and regulatory milestone payments of

预付款，并有资格获得开发和监管里程碑付款

$2.5 million

250万美元

for the first indication and

用于第一个适应症和

$1.5 million

150万美元

for each indication thereafter, up to

对于此后每个适应症，最多

$79 million

7900万美元

in potential sales-based milestones, and a tiered mid-to-high single-digit royalty on potential global net sales of AZD7325. Under the terms of the License Amendment,

基于潜在销售额的里程碑，以及对AZD7325潜在全球净销售额的分层中高个位数专利费。根据许可修正案的条款，

AstraZeneca

阿斯利康

will receive a cash upfront payment in the single digit millions and is eligible to receive development and regulatory milestone payments for each indication, sales-based milestones, and a tiered mid-to-high single-digit royalty on potential global net sales of AZD7325.

将获得一笔数百万美元的现金预付款，并有资格获得每个适应症的开发和监管里程碑付款、基于销售的里程碑付款，以及AZD7325潜在全球净销售额的分级中高个位数特许权使用费。

About Epilepsy

关于癫痫

Epilepsy is a chronic and debilitating neurological disorder that affects approximately 3.4 million people in the

癫痫是一种慢性且使人衰弱的神经系统疾病，大约影响着340万人

U.S.

美国

, with about 150,000 new cases diagnosed each year.

，每年约有150,000新病例被诊断出来。

1-3

1-3

It is characterized by recurrent, unprovoked seizures, or sudden and uncontrolled surges of electrical activity in the brain that can cause involuntary movements, sensory disturbances, loss of awareness, or convulsions.

它表现为反复发作的、无端的癫痫发作，或大脑中突然且不受控制的电活动激增，这可能导致不自主的动作、感觉障碍、意识丧失或抽搐。

3,4

3,4

People living with epilepsy often face stigma, barriers to education and employment, higher rates of comorbid psychiatric conditions, and increased risk of premature mortality, contributing to reduced quality of life and social isolation.

癫痫患者常常面临病耻感、教育和就业障碍、共患精神疾病的比例较高以及早逝风险增加等问题，导致生活质量下降和社会孤立。

5-7

5-7

Despite currently available treatment options, more than one-third of patients do not respond to treatment.

尽管目前有可用的治疗方案，但仍有超过三分之一的患者对治疗没有反应。

8

8

About

关于

Axsome Therapeutics

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.

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，并专注于新颖作用机制，开发出差异化产品，从而在患者疗效方面取得有意义的进步。

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批准的用于治疗重度抑郁症、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，并且还包含多个处于后期开发阶段的项目，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”、“持续”、“估计”、“预期”、“计划”、“打算”、“可能”、“能够”、“也许”、“将会”、“应该”等词语来表达未来事件或结果的不确定性，以此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就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进行的临床试验的成功、时间安排和成本，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，此假设基于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接收，这些结果不一定代表公司正在进行的临床试验的最终结果，和/或数据读出，以及支持公司当前任何产品候选者提交新药申请（“NDA”）所需的研究数量或类型或结果性质；公司为继续推进其产品候选者而资助额外临床试验的能力；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.

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可接受的成本获得必要许可的能力（如果可以的话）；公司成功解决任何知识产权诉讼的能力，即使此类争议得以解决，相关联邦机构是否会批准该等和解；公司研发计划和合作的成功实施；公司许可协议的成功；市场对公司产品及产品候选物的接受度（如获批准）；公司的预期资本需求，包括用于SUNOSI、AUVELITY和SYMBRAVO商业化以及公司其他产品候选物商业上市（如获批准）所需的资本金额，及其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维持有利的总销售额至净销售额比率的能力；因国内政治气候、地缘政治冲突或全球疫情及其他因素（包括一般经济状况和监管发展）而产生或相关的意外情况或对正常业务运营的其他干扰，这些因素均不在公司控制范围内。

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内容有重大差异。前瞻性声明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声明的义务。

Investors:

投资者：

Ashley Dong

董艾希

Director, Investor Relations

投资者关系总监

(929) 687-1614

(929) 687-1614

adong@axsome.com

adong@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

dopland@axsome.com

References

参考文献

CDC

疾控中心

. Epilepsy Facts and Stats.

癫痫的事实与统计数据。

https://www.cdc.gov/epilepsy/data-research/facts-stats

https://www.cdc.gov/epilepsy/data-research/facts-stats

. Accessed

. 已访问

September 2025

2025年9月

.

。

Cleveland Clinic

克利夫兰诊所

. Epilepsy.

癫痫。

https://my.clevelandclinic.org/health/diseases/17636-epilepsy

https://my.clevelandclinic.org/health/diseases/17636-epilepsy

. Accessed

. 已访问

September 2025

2025年9月

.

。

Institute of Medicine (US) Committee on the Public Health Dimensions

美国医学研究所公共卫生维度委员会

of the Epilepsies; England MJ, Liverman CT, Schultz AM, et al., editors. Epilepsy Across the Spectrum: Promoting Health and Understanding.

癫痫；英格兰MJ，利弗曼CT，舒尔茨AM等，编辑。《跨越癫痫谱系：促进健康与理解》。

Washington

华盛顿

(DC):

（直流）：

National Academies Press

国家学术出版社

(US); 2012.

（美国）；2012年。

https://www.ncbi.nlm.nih.gov/books/NBK100589

https://www.ncbi.nlm.nih.gov/books/NBK100589

National Institute of Neurological Disorders and Stroke

国立神经疾病和中风研究所

. Epilepsy and Seizures.

癫痫和发作。

https://www.ninds.nih.gov/health-information/disorders/epilepsy-and-seizures

https://www.ninds.nih.gov/health-information/disorders/epilepsy-and-seizures

. Accessed

. 已访问

September 2025

2025年9月

.

。

de Souza JL et al. The Perceived Social Stigma of People with Epilepsy with Regard to the Question of Employability. Neurol Res Int. 2018;2018:4140508.

德·苏扎 JL 等。癫痫患者在就业问题上所感受到的社会污名。《国际神经病学研究》。2018；2018：4140508。

https://pubmed.ncbi.nlm.nih.gov/29862075

https://pubmed.ncbi.nlm.nih.gov/29862075

Mula M et al. Psychiatric Comorbidities in People with Epilepsy. Neurol Clin Pract. 2021 Apr;11(2):e112-e120.

Mula M 等。癫痫患者的精神共病。《神经病学临床实践》。2021年4月；11(2):e112-e120。

https://pubmed.ncbi.nlm.nih.gov/33842079

https://pubmed.ncbi.nlm.nih.gov/33842079

Thurman DJ et al. The burden of premature mortality of epilepsy in high-income countries: A systematic review from the

Thurman DJ 等。高收入国家癫痫过早死亡的负担：系统评价来自

Mortality Task Force

死亡率特别工作组

of the

的

International League Against Epilepsy

国际抗癫痫联盟

. Epilepsia. 2017 Jan;58(1):17-26.

癫痫。2017年1月；58（1）：17-26。

https://pubmed.ncbi.nlm.nih.gov/27888514

https://pubmed.ncbi.nlm.nih.gov/27888514

Chen Z, et al. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. JAMA Neurol.

陈泽等。使用传统和新型抗癫痫药物治疗新诊断癫痫患者的治疗结果：一项为期30年的纵向队列研究。《JAMA神经病学》。

Mar 1

3月1日

;75(3):279-286.

;75(3):279-286.

https://pubmed.ncbi.nlm.nih.gov/29279892

https://pubmed.ncbi.nlm.nih.gov/29279892

Source: Axsome Therapeutics, Inc.

来源：Axsome Therapeutics, Inc.