- Industry veteran brings over 35 years of biotech experience as a successful entrepreneur and investor - Operating experience to significantly enhance development program of CID-103 (anti-CD38 mAb) SOUTH SAN FRANCISCO, CA / ACCESS Newswire / September 26, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced the appointment of James Huang as ...

Woburn, MA, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc., (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced that it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2025 Investor Conference, taking place virtually on Tuesday, September 30, 2025. Company Webcast The webcast presentation will take place at 1:15 p.m. ET on Tuesday, ...

公司动态与战略 - Amneal Pharmaceuticals宣布向美国FDA提交了其奥马珠单抗生物类似药的生物制品许可申请[1] - 该BLA的提交时间早于预期 预计将在2025年第三季度产生2250万美元的研发里程碑费用 而非此前预期的第四季度[5] - Amneal拥有该产品在美国的独家商业化权利 前提是获得监管批准[5] - 公司高管表示 该产品是未来几年重要的潜在增长催化剂 并有望成为首批进入该市场的奥马珠单抗生物类似药之一[4] 产品与市场机会 - 所提交BLA的产品是XOLAIR（奥马珠单抗）的拟议生物类似药 原研药XOLAIR是诺华公司的注册商标[1] - 奥马珠单抗是一种针对游离IgE的人源化单克隆抗体 适应症包括中重度持续性哮喘、伴有鼻息肉的慢性鼻窦炎、食物过敏和慢性自发性荨麻疹[2] - 根据IQVIA数据 截至2025年7月的12个月内 XOLAIR在美国的年销售额总计约41亿美元[4] - 此次BLA提交标志着公司有机会进入这个规模超过40亿美元的美国市场[1][4] 产品组合与管线 - 对于Amneal而言 该产品是其生物类似药管线的重要组成部分 公司目前已有三款上市生物类似药 并预计从2026年到2027年还将推出五款生物类似药 包括这款奥马珠单抗生物类似药[4] - 对于合作伙伴Kashiv BioSciences而言 此次BLA提交是其不断扩大的生物类似药产品组合中的一个重要里程碑 其已上市产品包括RELEUKO和FYLNETRA[4] - Kashiv BioSciences是一家垂直整合的生物制药公司 拥有多项商业化和后期临床阶段资产[7]

Shares of Top KingWin Ltd (NASDAQ: WAI) rose sharply in pre-market trading after the company announced it entered into a sales contract with Walker Times International for the sale of 10,000 units of TK-D2C AI Robots.Top KingWin shares jumped 87.4% to $5.92 in the pre-market trading session.Here are some other stocks moving in pre-market trading.GainersMEDIROM Healthcare Technologies Inc. (NASDAQ: MRM) rose 242% to $4.96 in pre-market trading. Medirom announced plans to double installation of Authentication ...

Geneva, Switzerland, September 26, 2025 - Addex Therapeutics (SIX/NASDAQ: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced that it will report its Half-Year and Second Quarter 2025 Financial Results on September 30, 2025 and host a conference call to discuss the results on October 1, 2025. Tim Dyer, CEO and Mikhail Kalinichev, Head of Translational Science, will provide a business upd ...

公司业务与研发进展 - 公司专注于开发罕见皮肤病治疗药物 是一家临床阶段生物制药公司[1] - 扩展QTORIN™ 3.9%雷帕霉素无水凝胶项目 新增临床显著性血管角化瘤适应症 该罕见淋巴疾病在美国影响超过50,000名患者[1] - 计划在2026年下半年启动II期临床试验 目标成为首个FDA批准的血管角化瘤疗法[1][2] - 当前治疗方案有限且通常伴随疼痛性操作 存在瘢痕形成和复发风险[2] - 计划2026年初与FDA会晤讨论II期研究设计 试验规模为10-20名患者[3] - 正在其他研究中评估QTORIN雷帕霉素 预计2025年12月中旬和2026年初获得结果[3] 技术平台与战略定位 - 持续利用专利保护的QTORIN平台开发新型疗法[3] - 公司战略聚焦于治疗严重罕见皮肤病的未满足医疗需求[2] 财务表现与流动性状况 - 当前市盈率为负值 -26.45 企业价值与经营现金流比率为负值 -42.71[5][6] - 流动比率达7.67 显示公司拥有充足流动资产覆盖负债[5][6] 市场评级与股价表现 - H.C. Wainwright于2025年9月25日将评级上调至"买入" 目标价从75美元提高至95美元[4] - Stifel Nicolaus分析师Annabel Samimy设定80美元目标价 较当时59.87美元价格存在约33.62%上涨潜力[4] - 评级调整时股价为58.87美元[4]

Accessibility StatementSkip Navigation PHILADELPHIA, Sept. 25, 2025 /PRNewswire/ -- Berger Montague PC is investigating claims under the federal securities laws against Altimmune, Inc. (NASDAQ: ALT) ("Altimmune" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for obesity and liver disease, including MASH (metabolic dysfunction-associated steatohepatitis) after a class action lawsuit was filed against Altimmune. Investor Deadline: Investors who purchased ...

– KOMET-001 in R/R NPM1-m AML met its primary endpoint with ziftomenib monotherapy demonstrating significant clinical benefit and deep responses – – Consistent activity across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, lines of therapy, or FLT3/IDH co-mutations – – Favorable safety and tolerability profile, including a lack of clinically significant QTc prolongation or myelosuppression – – Prescription Drug User Fee Act (PDUFA) target action date for FDA Priority Review of ziftomen ...

公司活动 - 公司将于2025年10月6日举办投资者网络研讨会，重点介绍其针对疼痛的早期阶段项目 [1][2] - 研讨会主题为“开发新型非阿片类疼痛疗法：Xenon公司Nav1.7和Kv7项目概述”，时间为美国东部时间上午11:30至下午12:30 [2] - 直播录像将在公司网站“投资者”栏目提供回放，且上述日期和时间可能会有变动 [3] 研发管线与战略重点 - 公司是一家专注于神经科学的生物制药公司，致力于为有需要的患者进行药物发现、临床开发和商业化 [1][4] - 公司的主要分子azetukalner是一种新型、强效、选择性的Kv7钾通道开放剂，正处于治疗癫痫、重度抑郁症和双相抑郁症的3期临床试验阶段 [4] - 公司正在推进包括Kv7和Nav1.7在内的多个有前景的钾通道和钠通道调节剂的早期项目组合，这些项目处于1期临床开发阶段，旨在探索其治疗疼痛的潜力 [1][4]

MONTREAL, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, announced today the completion of the previously-announced plan of arrangement under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC (the “Purchaser”), an affiliate of Future Pak, LLC (“Future Pak”), pursuant to which the Purchaser has acquired all the issued and outstanding commo ...