NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held May 28-31, 2024, in Miami Beach, Florida. The presentations include new data from post ...

NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in two upcoming investor conferences. The presentation details are as follows: RBC Capital Markets 2024 Global Healthcare Conference, on Tuesday, May 14, at 1:35 p.m. Eastern Time. Dr. Tabuteau will pa ...

NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in two upcoming investor conferences. The presentation details are as follows: RBC Capital Markets 2024 Global Healthcare Conference, on Tuesday, May 14, at 1:35 p.m. Eastern Time. Dr. Tabuteau will pa ...

Axsome Therapeutics, Inc. (AXSM) reported an adjusted loss of $1.00 per share for the first quarter of 2024, compared with a loss of 22 cents per share reported in the year-ago period. The Zacks Consensus Estimate was pegged at a loss of $1.20 per share.The above-adjusted loss excludes the impact of certain non-cash charges, including which the reported loss per share was $1.44 in the first quarter of 2024 compared with a loss of 26 cents per share reported in the year-ago quarter.The company reported total ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-37635 AXSOME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 45-4241907 (State or othe ...

财务数据和关键指标变化 - 第一季度总产品收入为7500万美元,同比增长约160% [13] - Auvelity产品净销售额为5340万美元,同比增长240% [24] - Sunosi产品净收入为2160万美元,包括2070万美元产品销售和90万美元特许权使用费收入 [25] - 总营业成本为630万美元,去年同期为760万美元,其中包括500万美元Sunosi许可交易费用分摊 [26] - 研发费用为3680万美元,去年同期为1780万美元,主要用于启动新的临床试验 [27] - 销售、一般及管理费用为9900万美元,去年同期为7420万美元,主要用于Auvelity和Sunosi的商业化活动 [28] - 第一季度净亏损为6840万美元,去年同期为1120万美元净亏损 [29] - 截至第一季度末,公司现金及等价物余额为3.314亿美元 [31] 各条业务线数据和关键指标变化 - Auvelity处方量约9.5万个,环比增长12%,同比增长206% [34] - 新增Auvelity患者近1.8万人,累计治疗患者超过8.9万人 [34] - 新开具Auvelity处方的医生超过3.6万名 [34] - Sunosi处方量略有下降1.6%,但同比增长14% [38] - 新增Sunosi患者约3700人,累计治疗患者约6.8万人 [38] - 新开具Sunosi处方的医生超过400名,累计超过1.26万名 [38] 各个市场数据和关键指标变化 - Auvelity获得约70%的受保患者覆盖 [36] - 公司刚与一家大型采购组织签约,为Auvelity的潜在处方药覆盖奠定基础 [36] - Sunosi获得约83%的受保患者覆盖 [38] 公司战略和发展方向及行业竞争 - 公司拥有5个处于后期临床阶段的创新神经科学产品管线,覆盖10种严重的精神和神经系统疾病 [19][20] - 正在推进AXS-07、AXS-14和solriamfetol的新药申请,并启动了AXS-12、AXS-05和solriamfetol的新适应症的III期临床试验 [15][16][17][18] - 公司认为AXS-12、AXS-05和solriamfetol有望为严重的精神神经系统疾病患者提供差异化的治疗选择 [20] - 公司认为AXS-05在阿尔茨海默病激动症治疗领域仍有重大未满足的临床需求,即使有布瑞匹嗪上市 [49] - 公司计划将AXS-05定位为阿尔茨海默病激动症的首选治疗方案 [50] 管理层对经营环境和未来前景的评论 - 公司第一季度取得了强劲的财务业绩,其上市产品为患者提供了重要且差异化的治疗选择 [12] - 公司的创新神经科学管线取得了重大进展,包括AXS-12在催眠症临床试验取得积极结果,AXS-07和AXS-14推进新药申请,solriamfetol启动新适应症III期试验,以及AXS-05在阿尔茨海默病激动症适应症取得进展 [14] - 公司有信心在2024年保持商业和管线的良好势头 [14] - 公司认为AXS-12有望为患者提供一种差异化的治疗选择,满足目前治疗催眠症的未met需求 [69][70][71][72] - 公司认为AXS-05有望成为阿尔茨海默病激动症的首选治疗方案 [49][50] 问答环节重要的提问和回答 问题1 **Charles Duncan 提问** 询问Auvelity新增患者和复诊患者的占比情况 [43][44][45][46] **Ari Maizel 回答** 新增患者占比约25%-30%,复诊患者占比较高,公司观察到患者依从性和持续性较好 [44][45][46] 问题2 **Ram Selvaraju 提问** 询问与第三大GPO谈判的具体因素 [63][64] **Ari Maizel 回答** 主要取决于公司在市场上的需求增长情况,公司将继续优化患者支付和报销支持服务以推动需求增长 [64][65][66][67] 问题3 **Herriot Tabuteau 回答** 公司认为AXS-12在催眠症治疗中有很好的临床特征,包括对嗜睡和认知功能的改善,以及对催眠发作的显著减少,有望为患者提供差异化的治疗选择 [69][70][71][72]

Exhibit 99.1 Axsome Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth Auvelity® 1Q 2024 net product sales of $53.4 million, representing 240% year-over-year growth Sunosi® 1Q 2024 net product revenue of $21.6 million representing 64% year-over-year growth Contract executed with second large group purchasing organization (GPO) for potential coverage of Auvelity Positive pivotal Pha ...

Biotech stocks offer the opportunity to invest in life-saving treatments and drugs. So not only can you make massive gains but you are also investing in the advancement of modern medicine. But not all biotech companies are the same. Some are established pharmaceutical giants while others are pre-revenue startups that are banking on a drug breakthrough. What this means is that an FDA approval or denial can have major consequences on the stock. If you want to invest in biotech stocks, you will need to keep up ...

The market expects Axsome Therapeutics (AXSM) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 6, 2024, might help the stock move higher if these key numbers ar ...

AXS-05 in Alzheimer's disease agitation data featured in oral plenary session New data for AXS-07 in migraine demonstrating efficacy in pooled analysis Presentations on cognitive and wake promoting effects of solriamfetol NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations highlighting its innovative psychiatry and ...