https://securitiesclasslaw.com/securities/savara-inc-loss-submission-form/?id=168877&from=4 CLASS PERIOD: March 4, 2024 to May 23, 2025 ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (i) MOLBREEVI BLA, the treatment of pulmonary alveolar proteinosis, lacked sufficient information regarding MOLBREEVI's chemistry, manufacturing, and/or controls; (ii) accordingly, FDA was unlikely to approve the MO ...

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.Considering buying BIIB stock? Here’s what analysts think: Read This Next: Photo via ShutterstockLoading...Loading... ...

UniQure NV (NASDAQ: QURE) just staged one of biotech's wildest rides of the year, soaring 248% in a single session after unveiling successful trial results for its experimental Huntington's disease gene therapy. Indeed, the stock reached a 5-year high, marking its best session ever. But if you think the move was a one-off sugar high, Wall Street begs to differ.Track QURE stock here.Read Also: uniQure Stock Jumps On Positive News, But Risks RemainAnalysts Flip Bullish, Targets Race HigherThe clinical data di ...

Company to deliver oral and poster presentations for data on leronlimab’s action on PD-L1 expression and patient survival in triple-negative breast cancer VANCOUVER, Washington, Sept. 25, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and colo ...

About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...

核心观点 - 公司宣布将在多个科学会议上展示其主导产品候选物INO-3107用于治疗复发性呼吸道乳头状瘤病（RRP）的数据 并已开始滚动提交生物制剂许可申请（BLA） 预计2025年下半年完成提交 目标在2025年底前获得美国食品药品监督管理局受理 [1] - 公司还将重点介绍其下一代DNA药物技术 包括DNA编码单克隆抗体（DMAb）候选产品的1期临床试验数据以及针对A型血友病的DNA编码蛋白质技术（DPROT）的临床前数据 [2][4][5] 产品研发进展 - 主导产品候选物INO-3107针对HPV-6/11引起的复发性呼吸道乳头状瘤病（RRP） 数据显示其可诱导持久免疫反应并实现长期疗效 治疗后第二年仍有效 [1][3][5] - 公司已开始滚动提交INO-3107的生物制剂许可申请（BLA） 预计2025年下半年完成提交 目标在2025年底前获得美国食品药品监督管理局受理 [1] 会议展示安排 - 公司将在10月11日至13日美国耳鼻咽喉头颈外科学会年会上展示INO-3107治疗HPV-6/11复发性呼吸道乳头状瘤病的持久反应数据 [3] - 公司将在10月13日世界疫苗大会欧洲会议上展示INO-3107在HPV-6/11复发性呼吸道乳头状瘤病中的长期疗效数据 [3] - 公司将在10月19日欧洲肿瘤内科学会大会上展示INO-3107在HPV-6/11复发性呼吸道乳头状瘤病中的长期疗效数据 [3] - 公司将在10月24日国际乳头瘤病毒学会会议上展示INO-3107的临床反应与乳头瘤微环境和分子亚型无关的数据 [3] - 公司将在10月25日国际乳头瘤病毒学会会议上展示INO-3107诱导持久免疫反应并实现长期疗效的数据 [3] - 公司将在10月30日国际疫苗学会年会上展示INO-3107具有良好的耐受性、有效性并能引发抗原特异性T细胞反应的数据 [3] - 公司将在10月7日至10日欧洲基因与细胞治疗学会大会上展示其CELLECTRA体内基因递送平台在首个人体DNA编码单克隆抗体（DMAb）临床试验中的应用 [4] - 公司将在10月16日世界疫苗大会欧洲会议上展示DMAb技术的设计与递送 [4] - 公司将在10月29日世界孤儿药大会上展示DMAb技术在罕见病中的变革潜力 [4] - 公司将在11月14日世界血友病联盟全球论坛上展示通过非病毒载体DNA药物平台实现新型FVIII分泌的数据 [4] 技术平台发展 - 公司开发了下一代DNA药物技术 包括DNA编码单克隆抗体（DMAb）和DNA编码蛋白质技术（DPROT） [2][4][5] - DMAb技术已在1期临床试验中进行评估 DPROT技术针对A型血友病展示了新的临床前数据 [2][4][5] - 公司利用CELLECTRA体内基因递送平台优化DNA药物的设计与递送 [4][6]

CHARLESTOWN, Mass., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, will present data from the Phase 1/2 INSPIRE DUCHENNE trial evaluating SGT-003, a next-generation investigational gene therapy intended for the treatment of Duchenne muscular dystrophy (Duchenne), at the 26th Annual Scientific Meeting of Neuromuscular Study Group (NMSG), September 26-28, 2025, in Stresa, Italy. Pr ...

Common Stock Will Begin Trading on Split-Adjusted Basis on September 30, 2025PITTSBURGH, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (Nasdaq: POAI), a leader in AI-driven drug development and discovery, today announced that it will effect a 1-for-15 reverse stock split of its issued and outstanding shares of common stock. The reverse stock split will become effective at 12:01 a.m. on Tuesday, September 30, 2025. Predictive Oncology’s common stock will continue to be traded on Nasdaq under th ...

Accessibility StatementSkip Navigation LAS VEGAS, Sept. 25, 2025 /PRNewswire/ -- Avant Technologies Inc. (OTCQB:Â AVAI) ("Avant" or the "Company"), today announced a pivotal evolution in its business direction, emphasizing strategic partnerships through joint ventures and licensing agreements to advance treatments for a range of chronic and age-related conditions. In alignment with this refined mission, the company has applied for a corporate name change to better reflect its focus on pioneering biotechnolo ...

新产品发布 - 公司推出第四代靶向整合技术平台TrueSite TI™ 基于CHO细胞系 旨在重塑生物制剂开发流程 加速时间线 提升产品质量 并确保抗体和复杂蛋白疗法的一致可扩展性 [1] - 该平台通过精准细胞工程技术将目标表达单元递送至宿主细胞预定义位置 相比传统随机整合或转座酶方法 将克隆筛选限制在数十个候选者内 确保长期表达稳定性 并显著缩短IND时间线 [2] - 平台实现单克隆抗体平均滴度超过8.0 g/L 支持高产商业制造 超过99%的克隆细胞系在传代60代后保持稳定蛋白表达 有效缓解放大生产至20,000升时的滴度下降风险 [3][6] 技术平台优势 - TrueSite TI™作为WuXia™平台第四代产品 在过去十年中经过超过1000个分子的技术演进和验证 驱动更高效率和质量 [3] - 平台不仅适用于单克隆抗体开发 还展示出对双特异性抗体、Fc融合蛋白和Fab片段等复杂生物制剂的强大适用性 提供卓越细胞系稳定性和可预测生长特性 [3][6] - 通过简化工艺开发流程 平台提供行业领先的6个月IND时间线 加速突破性疗法的临床试验进程 [3][6] 平台家族扩展 - WuXia™平台家族包括用于增强ADCC效应的去岩藻糖抗体开发平台WuXiaPlus™ 非抗生素细胞系开发平台WuXia RidGS™ 以及基于HEK293细胞系的难表达分子平台WuXia293 [5][7] - 截至2024年 该平台家族已在全球监管机构认可下产生超过1000个细胞系 用于临床和商业制造 表达单克隆抗体、双特异性抗体、融合蛋白和酶等多种重组蛋白 [5] - 平台家族持续扩展以满足全球客户多样化需求 体现公司在细胞系开发领域的技术领导地位 [7]