NEW YORK, June 06, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 27, 2025, Sava ...

Savara Inc (SVRA) 2025 Conference June 04, 2025 09:20 AM ET Speaker0 Okay. We're going to get started with our next session. I'm Andrew Tsai, senior biotech analyst at Jefferies. It's my pleasure to have the Savara team with me today. To my direct left is Rob Lutz, COO. To his left is Matt Pauls, Chairman and CEO. And to Matt's left is Sid Advante, EVP of Technical Operations. Welcome, all of you. Speaker1 Thanks very much. Speaker0 So, as always, maybe for those who are less familiar with the Savara story, ...

NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 27, 2025, Sava ...

NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Savara and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 27, 2025, Savar ...

ATLANTA, May 27, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) complied with federal securities laws. On May 27, 2025, Savara announced that it had received a refusal to file letter from the FDA for the Biologics License Application of MOLBREEVI as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis. Following this news, the price of the Company’s stock dropped.  If you purchased Savara stock and suffered  ...

Savara Inc. SVRA on Tuesday announced that it received a U.S. Food And Drug Administration (FDA) refusal To File (RTF)) letter regarding the Biologic license application (BLA) for Molbreevi, a therapy for treating patients with autoimmune Pulmonary Alveolar Proteinosis (PAP).Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the lungs’ alveoli.Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent th ...

BOSTON, May 27, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Savara Inc. (Nasdaq: SVRA) for potential securities law violations. Investors who have lost money in their Savara Inc. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/svra. What is this all about? Shares of Savara fell over 30% in intraday trading on May 27, 2025, after the company announced that the FDA issued a Refusal to File letter f ...

Savara Inc (SVRA) FY 2025 Conference May 20, 2025 04:30 PM ET Speaker0 Andrew, thank you. Thank you all for being here today, those in person and anyone listening to the recast later on. Again, my name is Dave Lorance. I'm Savara's Chief Financial and Administrative Officer. I will do the obligatory safe harbor statement regarding today's presentation. For those of you that don't know our story, have not followed Savara in quite some time, we are a clinical stage biopharmaceutical company currently focused ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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 001-32157 Savara Inc. (Exact name of registrant as specified in its charter) Delaware 84-1318182 FORM 10-Q (State or other jurisdiction of inc ...

纪要涉及的公司 Savara Inc (SVRA)，一家专注于罕见孤儿呼吸道肺病的公司，拥有单一资产——新型吸入性生物制剂molgermostum吸入溶液 [4] 纪要提到的核心观点和论据 1. **公司战略与进展** - 公司正积极寻求FDA对治疗罕见肺部疾病autoimmune pap的批准，基于IMPALA 2期3期试验结果，有望年底获优先审评和批准，同时年底将在欧洲和英国提交上市许可申请（MAA） [4][5] 2. **疾病介绍** - autoimmune PAP是一种慢性罕见自身免疫性疾病，患者会产生针对GM - CSF的自身抗体，阻止其与巨噬细胞表面结合，导致肺泡内表面活性物质积聚，阻碍气体交换，引发咳嗽、气短和疲劳等症状 [8][9][10] - 诊断患病率估计范围为每百万人中有6 - 26例，美国已确诊约3600例患者，通过机器学习算法还发现约3700例疑似未确诊患者 [11][12] 3. **产品作用机制与临床数据** - molgrimostem是一种吸入性重组GM - CSF，患者每天使用专用雾化器吸入一次，可使外源性GM - CSF克服抗体，与巨噬细胞结合，发挥作用 [20][21] - IMPALA 2试验是该疾病领域最大、最长的随机临床试验，全球43个中心16个国家的64名患者参与，为期48周双盲研究，患者随机接受molgrimostem或安慰剂治疗 [22] - 主要终点是24周时DLCO（肺一氧化碳弥散量）的变化，该指标在24周和48周均有统计学意义，显示出疗效的持久性；关键次要终点包括48周时的DLCO、患者报告结局SGRQ（圣乔治呼吸问卷）和运动能力测试，均有显著改善 [23][24][25] - 164名患者入组，159名完成48周双盲安慰剂对照试验并进入开放标签扩展阶段，Molbrevi安全性和耐受性良好，获益风险明显 [29][30] 4. **审评流程** - 滚动生物制品许可申请（BLA）于3月完成，60天审评期后预计5月获受理，因有突破性疗法认定，预计获优先审评，若获批，PDUFA日期为11月，同时计划进行咨询委员会（AdCom）会议 [32][33] 5. **支付方研究与定价** - 目前患者治疗方法包括肺灌洗（一种痛苦且恢复时间长的急救程序）和一些非标签药物 [39][40] - 与支付方沟通后，产品定价指导范围为每位患者每年30万 - 50万美元，该范围内约87%的支付方会覆盖，将采用商业保险计划标准、专科层级、预先授权和诊断证明等方式，由单一专科药房处理 [41][42] 6. **市场覆盖预期** - 上市初期，商业保险覆盖预计为60 - 70%，目前患者确诊年龄较晚，公司将努力提前诊断时间 [43] 7. **产品上市计划** - 有干血斑抗体检测项目和佛罗里达大学的ILD诊所试点项目，将扩大到其他ILD诊所，预计年中约一半市场开发团队到位，开展教育和患者确认工作，为获批后快速上市做准备 [46][48][49] 8. **资金状况** - 资产负债表上有9600万美元现金，近期完成约3000万美元债务再融资，与Hercules合作创建高达1.7亿美元的夹层结构债务融资方案，目前资金可支撑到2027年第二季度 [50][51] 其他重要但是可能被忽略的内容 - 公司推出了干血斑检测，可帮助患者通过敏感和特异的诊断方法加快诊断速度 [16] - 目前正在进行的ILD诊所试点项目针对的是未确诊患者群体，具有较大潜力 [48]