LOS ANGELES--(BUSINESS WIRE)---- $SVRA--SVRA Investors Have Opportunity to Lead Savara Inc. Securities Fraud Lawsuit with the Schall Law Firm. ...

NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Savara Inc. (“Savara” or “the Company”) (NASDAQ: SVRA) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Savara securitie ...

NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) and certain officers.   The class action, filed in the United States District Court for the Eastern District of Pennsylvania, and docketed under 25-cv-05147, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Savara securities between March 7, 2024 and May 23, 2025, ...

SAN DIEGO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Robbins LLP reminds stockholders that a class action was filed on behalf of persons and entities that purchased or otherwise acquired Savara Inc. (NASDAQ: SVRA) securities between March 7, 2024 and May 23, 2025. Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company’s lead product candidate is MOLBREEVI (also referred to as “molgramostim”), an inhaled granulocyte-macrophage colony-stimulating (“GM-CSF”) factor. For ...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Savara (SVRA) To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Savara between March 7, 2024 and May 23, 2025 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648. NEW YORK, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder ri ...

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN SAVARA (SVRA), CONTACT THE LAW OFFICES OF HOWARD G. SMITH ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@ho. ...

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP, a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) investors concerning the Company's possible violations of the federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON SAVARA (SVRA), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. What Happened? On May 27, 2025, Savara issue. ...

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) on behalf of investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON SAVARA (SVRA), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS. What Is The Investigation About? On May 27, 2025, Savara issued a press release announcing that the U.S. Food and Drug A. ...

NEW YORK--(BUSINESS WIRE)---- $SVRA #ClassAction--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Savara Inc. ("Savara†or the "Company†) (NASDAQ: SVRA) and reminds investors of the November 7, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has ...

公司概况 * Savara Inc (纳斯达克代码 SVRA) 是一家专注于罕见肺部疾病的单一资产公司 其核心资产是Mobrevi (morgamostim吸入溶液) 用于治疗自身免疫性肺泡蛋白沉积症 (autoimmune PAP或APAP) [1] 核心产品Mobrevi * Mobrevi是一种药物-器械组合产品 每日一次吸入300微克 是一种新型吸入生物制剂 通过专有的eFlow雾化器系统给药 [4] * 雾化时间约5分钟 包括设置和清理在内的总时间约20分钟 [4] * 在2024年中宣布其全球关键3期注册试验Impala 2获得阳性结果 [4] * 主要终点DLCO(气体交换测量)在24周时达到统计学阳性 并在48周时保持统计学阳性 [5] * 关键次要终点包括圣乔治呼吸问卷(SGRQ)在24周时达到统计学显著或名义显著 48周时跑步机测试的运动能力也达到名义显著 [5] * 安全性良好 停药率仅3% 且无因药物相关不良事件导致的停药 [6] * 完成48周安慰剂对照试验的159名受试者全部(100%)进入了开放标签扩展研究 [6] * Impala 2试验结果最近发表于新英格兰医学杂志 之前的Impala试验(2-3期研究)也于2020年秋季发表在同一期刊 [6][7] 疾病背景 * 自身免疫性PAP是一种严重的长期慢性肺部疾病 由肺泡巨噬细胞功能障碍引起 [1] * 由GMCSF自身抗体阻断GMCSF信号传导 导致表面活性物质清除减少 [1] * 主要症状包括进行性呼吸短促(呼吸困难)、慢性咳嗽、肺部感染风险增加、疲劳和运动耐量下降 [2] * 部分患者会进展为纤维化 甚至需要肺移植 [3] * 目前美国和欧洲尚无批准的治疗药物 唯一可用的抢救程序是全肺灌洗 这是一种侵入性操作 需要全身麻醉和住院 使用20-30升生理盐水"冲洗"肺部 [3] 监管与知识产权 * 计划于2025年12月重新提交美国BLA申请 [7] * 假设60天备案审查期并获得优先审评资格 PDUFA日期可能在2026年8月 [7] * 欧盟和英国的MAA将于2026年第一季度提交 潜在批准时间为2027年第一季度 [8] * 在美国拥有孤儿药资格、快速通道资格和突破性疗法资格 [8] * 在欧洲拥有孤儿药资格 在英国拥有创新护照和有前景创新药物资格 [8] * 如果获批 将获得12年监管独占权 同时正在全球申请多项专利 [8] * 与PARI就eFlow雾化器系统拥有独家许可 并有待批的药物-器械组合联合专利申请 [8] 市场机会与商业化 * 定价区间为每年40万至50万美元 公司认为有真正的定价能力 [10] * 美国患者数量估计从2023年的约3,600人大幅增加至约5,500人(增长约50%) [11] * 新的索赔数据分析更加严谨 数据捕获量比之前分析高出约三倍 [11] * 目前有4名市场开发经理在进行确认工作 预计到年底将获得1,000名或更多患者的"视线范围" [12] * 在欧洲和英国(欧盟四国+英国) 总可寻址市场估计超过5,000名患者 [14] * 目前欧洲有62名患者参加了Impala 2开放标签扩展研究 [14] * 超过80%的肺科医生愿意处方Mobrevi 无论疾病严重程度如何 支付方也打算覆盖该药物 [10] 诊断与患者获取 * 公司推出了APAP ClearPath计划 这是一个免费的第三方检测项目 提供干血斑检测和血清检测 [9] * 干血斑检测只需几滴血在卡片上 邮寄到实验室 7天内医生可获得结果 [9] 财务情况 * 公司指导现金流可支持至2027年第一季度 第二季度末资产负债表上有1.46亿美元 [14] * 拥有强大的投资者支持 是一家受到广泛关注的公司 [14] 长期前景 * 病例系列显示5名APAP患者通过单患者通道接受Mobrevi治疗 平均治疗时间超过4年 治疗后无患者需要全肺灌洗 [7] * 公司相信Mobrevi获批后在美国、欧盟、英国以及潜在的亚太地区都有产生持久长期收入的真实潜力 [15]