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NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington. Details for the presentations are as follows: AXS-12 Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 405 Title: Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Oral Presentation Date and Time: Wednesday, June 11, 3:45 - 4 p.m. PT Oral Session: O-24 Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 390 Title: Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the CRESCENDO Survey Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Oral Presentation Date and Time: Wednesday, June 11, 4 - 4:15 p.m. PT Oral Session: O-24 Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 391 Solriamfetol Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-50 Poster Number: 366 Title: Real-World Use of Solriamfetol for Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnea in the US Lead Author: Yang Zhao, PhD, Axsome Therapeutics Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-50 Poster Number: 369 About AXS-12 AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA. About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). About 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. 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 United States. 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 www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements 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. 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®, AUVELITY®, and 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 U.S. Food and Drug Administration (“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. 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 statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com Source: Axsome Therapeutics, Inc.

精彩内容6月4日，国家药监局官网显示，倍特药业拿下了伏立康唑干混悬剂和门冬氨酸钾注射液，今年以来公司已累计获批了14个新产品、4款1类新药获批临床，公司的创新转型之路越走越顺。2024年在中国三大终端六大市场，倍特药业首次登上全身用抗细菌化药国内龙头集团，18个产品大卖超过1亿元，成绩亮眼。目前，公司已过评产品超过150个，还有73个仿制药新品报产在审；1款改良新药已获批，20款新药在路上，未来可期。首夺千亿市场国内龙头，18个过亿产品超亮眼据米内网统计，截至目前倍特药业（含子公司）已拥有化学药和中成药合计超过350个产品（不含原料药），2024年在中国三大终端六大市场（统计范围见文末），公司的畅销产品分布在50多个亚类市场，并已成功挺进12个亚类市场TOP20集团（二级，下同）之列，优势明显。2024年全身用抗细菌化药的销售规模在1093亿元左右。倍特药业近几年不断加码抢攻这个千亿市场，从2019年的TOP44集团一路飞升，并在2024年成功登上TOP2集团之位，排在辉瑞之后，成为该市场的新国内龙头集团。倍特药业的注射用氨苄西林钠、注射用阿莫西林钠克拉维酸钾(5:1)、注射用哌拉西林钠、头孢克肟分散片2024年在中国三大终端六大市场的销售额均超过3亿元，此外还有7个产品达到了亿元级别。图1：倍特药业的全身用抗细菌化药销售额及市场份额（二级集团）情况（单位：万元）来源：米内网格局数据库2024年阻塞性气管疾病用药（化+生）的销售规模超过270亿元。倍特药业自2021年开始腾飞，连续增长了512%、118%、24%、23%，公司该类药物的销售额在2024年升至9.5亿元，并成功登上TOP7集团。公司在2021年获批的吸入用布地奈德混悬液，在2024年大卖超过6.5亿元。2024年其他妇科用药（化+生）的销售规模超过30亿元。倍特药业近几年持续正增长，2019-2021年稳坐TOP5集团，2022-2023年跃升至TOP2集团，2024年虽下滑了1位至TOP3集团，但市场份额却升至12.19%，为近六年新高。公司的马来酸麦角新碱注射液在2024年大卖近4亿元。2024年中成药糖尿病用药的销售规模超过20亿元。倍特药业2023-2024年的销售额保持在1亿元以上，集团排名稳定在TOP8。热销产品糖脉康颗粒、糖脉康片、糖脉康胶囊是公司的独家产品。2024年治疗用放射性药物（化+生）的销售规模在5.9亿元左右。倍特药业在2023年3月获批了氯化锶[89Sr]注射液（首家过评），该产品助力公司在2024年登上该类药物市场TOP8集团。此外，2024年倍特药业还是抗痛风制剂化药市场TOP12集团、皮肤病用抗生素和化疗药化药市场TOP14集团、造影剂（化+生）市场TOP14集团、治疗与胃酸分泌相关疾病的化药市场TOP15集团、全身用抗病毒药（化+生）市场TOP17集团、胃肠解痉药及抗胆碱药和胃动力药化药市场TOP17集团、全身用抗真菌化药市场TOP19集团。表1：2024年在中国三大终端六大市场倍特药业销售额过亿的产品情况来源：米内网格局数据库2024年在中国三大终端六大市场，倍特药业TOP20产品中有18个销售额超过1亿元，其中吸入用布地奈德混悬液已成为了公司最畅销的产品。公司的马来酸麦角新碱注射液、注射用氨苄西林钠、注射用哌拉西林钠、达比加群酯胶囊、注射用头孢美唑钠连续三年保持正增长态势，已成为了重要的潜力产品。改良新药先拔头筹，12款1类新药来势汹汹图2：2022年至今倍特药业申报上市的新药来源：米内网中国申报进度（MED）数据库2024年4月，化药2.2类新药盐酸右美托咪定鼻喷雾剂获批上市，为倍特药业的创新药研发揭开了新篇章。目前公司还有水合氯醛糖浆报产在审，该产品也是一款改良新药，预计将在今年迎来好消息。2025年至今1-5月，倍特药业有4款新药获批临床，其中化药1类新药PRT-064040鼻喷雾剂和生物药1类新药BPR-102胶囊为首次申报临床并获批，化药1类新药BPR-30221616注射液和生物药1类新药HC006注射液为新适应症获批临床。4月，公司提交了化药1类新药SNH-119014片的临床申请，目前正在审评审批中……近几年，倍特药业的1类新药矩阵不断壮大，已累计布局了12款1类新药（化+生）。表2：倍特药业部分在研的重磅新药来源：米内网综合数据库8款1类新药已进入临床阶段，其中生物药1类新药BPR-101胶囊在2024年9月启动了细菌性阴道病II期临床，是目前公司研发进度最快的1类新药；化药1类新药BPR-30221616注射液在2024年12月启动了转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）I期临床，并在2025年1月完成了第一例入组。公司继续加码改良新药，盐酸(R)-氯胺酮鼻喷雾剂在今年4月启动了伴有急性自杀意念或行为的抑郁症II期临床；卡托普利口服溶液在2023年9月完成了I期临床；吸入用PRT-068已获得临床批件，还有3款新药的临床申请正在审评审批中。倍特药业目前暂无生物药获批上市，司美格鲁肽注射液的两个适应症分别在2024年3月、9月进入III期临床，离报产仅一步之遥，该产品有望成为公司首款获批的生物药。73个高端仿制药在路上，153个产品已过评6月4日，国家药监局发布最新药品获批信息，倍特药业拿下伏立康唑干混悬剂和门冬氨酸钾注射液，今年以来公司已累计获批了14个新产品，其中巴氯芬口服溶液、沙美特罗替卡松吸入粉雾剂、卡络磺钠片均为国产第二家获批，公司的抢仿实力不容小觑。表3：倍特药业今年以来获批的新产品来源：米内网中国申报进度（MED）数据库开拓新市场方面，早前倍特药业暂无肌肉松弛药和其它所有治疗用药品获批，巴氯芬口服溶液和硫代硫酸钠注射液为公司打开了两个新市场大门，2024年在中国三大终端六大市场，肌肉松弛药（化+生）的销售规模超过了40亿元，其它所有治疗用药品（化+生）的销售规模达到了68亿元。2023年至今，倍特药业及子公司还有73个高端化学药报产在审。螺内酯口服混悬液目前暂未有进口或国产产品获批，佩玛贝特片和阿糖胞苷注射液仅有原研批文，复方氨基酸注射液(17AA-Ⅲ)目前有原研地产化产品获批，倍特药业将参与上述产品的国内首仿争夺。此外，公司或将再有5个亚类市场迎来新突破。阿帕他胺片和枸橼酸托瑞米芬片将为公司开拓内分泌治疗用药市场，碘[131I]化钠口服溶液或将成为公司首个诊断用放射性药物，注射用吲哚菁绿或将成为公司首个诊断用药，唑来膦酸注射液或将成为公司首个影响骨结构及其矿化的药物，黄体酮注射液或将成为公司首个性激素及生殖系统调节剂。图3：倍特药业集采中标产品情况来源：米内网中国上市药品（MID）数据库截至2025年6月4日，倍特药业及子公司已过评/视同过评的产品有153个（按产品名统计），公司积极参与国家集中带量采购，前十批（除了第六批胰岛素专项）均有产品中标，“集采中标大户”实至名归。表4：倍特药业备战第十一批集采的产品来源：米内网中国上市药品（MID）数据库目前，倍特药业已过评且竞争企业在7家或以上的产品有39个，其中口服占了18个、注射占了19个，吸入占了2个。2025上半年仅剩最后一个月，行业大事备受瞩目，“集采中标大户”能否再接再厉，我们将继续跟踪报道，敬请关注。资料来源：米内网数据库、国家药监局官网注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至6月4日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦