文章核心观点 - 公司宣布完成SBMA(肌萎缩性脊髓性侧索硬化症)临床试验最后一例患者的最终随访 [1][2] - 公司期待在2024年中报告临床试验的顶线数据 [1][2] - 公司对AJ201在SBMA治疗中的前景保持乐观 [2] 公司概况 - 公司是一家专注于神经系统疾病治疗药物开发和商业化的专科制药公司 [8] - 公司目前正在开发三种资产,包括SBMA治疗药物AJ201、BAER-101和静脉注射曲美布汀 [8] - 公司总部位于迈阿密,由Fortress Biotech公司创立 [8] AJ201临床试验 - AJ201是一种首创的SBMA治疗候选药物 [5][6] - 该药物通过多种机制调节SBMA,包括降解异常的雄激素受体蛋白以及激活Nrf1和Nrf2通路 [5] - 第一期临床试验显示AJ201具有良好的安全性和药代动力学特征 [5] - 目前正在进行的第1b/2a期临床试验旨在评估AJ201在SBMA患者中的安全性、药代动力学/药效学数据和临床反应 [2][5] - 该临床试验已完成最后一例患者的随访,预计2024年中报告顶线数据 [1][2] SBMA疾病概况 - SBMA是一种罕见的X连锁遗传性神经肌肉疾病,主要影响男性 [4] - 该疾病由雄激素受体基因中的三核苷酸CAG重复扩张引起,导致产生异常的多谷氨酸蛋白聚集,引起肌肉萎缩 [4] - 目前尚无获批的治疗方法 [4] 多谷氨酸疾病概况 - 多谷氨酸疾病是一类由蛋白质中的多谷氨酸重复扩张引起的神经退行性疾病 [7] - 这类疾病的共同特征是突变蛋白质在受累组织中聚集,导致神经炎症、氧化应激和蛋白质质量控制失调 [7] - 同时调节多种细胞通路,如增强突变蛋白降解、诱导抗氧化和热休克反应、提高蛋白酶体表达,为AJ201在SBMA及其他多谷氨酸疾病治疗中的潜力提供了理论依据 [7]

Table of Contents 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 001-38114 AVENUE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-4113275 (State or othe ...

财务状况 - Avenue Therapeutics, Inc.（Nasdaq: ATXI）在2024年第一季度现金及现金等价物总额为320万美元，较2023年底的180万美元增加了140万美元[6] - 研发费用为2024年第一季度240万美元，较2023年第一季度的120万美元增加了100%[7] - 总体而言，2024年第一季度净亏损为430万美元，每股亏损15.40美元，较2023年第一季度的净亏损760.2万美元，每股亏损101.57美元有所减少[9]

– Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 – MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2024. "The first quarter was incredibly productive for ...

MIAMI, April 29, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase an aggregate of 689,680 shares of the Company's common stock. The exercised warrants are comprised of warrants to purchase shares of commo ...

股票合并公告 - Avenue Therapeutics宣布将进行1比75的股票合并，以符合纳斯达克每股最低1美元的要求[1] - 股票合并后，发行的普通股数量将从约4470万股减少到约60万股[2] - 股东持有股票的实物股份证书需要进行交换，持有股票在银行、经纪人或其他代理人名下的股东无需采取任何行动[3]

Table of Contents (Title of Class) Trading Symbol(s) (Name of exchange on which registered) Common Stock, par value $0.0001 per share ATXI Nasdaq Capital Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to . Commissi ...

Exhibit 99.1 Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights - Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 - - Presented positive BAER-101 preclinical data at American Epilepsy Society (AES) and American Society for Experimental Neurotherapeutics (ASENT) Annual Meetings and in publication Drug Development Research - - Final agreement reached with FDA on study d ...

- Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 - - Presented positive BAER-101 preclinical data at American Epilepsy Society (AES) and American Society for Experimental Neurotherapeutics (ASENT) Annual Meetings and in publication Drug Development Research - - Final agreement reached with FDA on study design and analysis approach for Phase 3 safety study of IV tramadol – MIAMI, March 18, 2024 (GLOBE NEWSWIR ...

MIAMI, March 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue" or the "Company"), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company's request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price ...