Trevi Therapeutics (NasdaqGM:TRVI) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Good afternoon and welcome to the Trevi Therapeutics third quarter 2025 earnings conference call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your phone. To withdraw ...

Relmada Therapeutics (NasdaqGS:RLMD) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker4Good afternoon and welcome to Relmada Therapeutics third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question-and-answer session. To ask a question, please press star and one. As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the ...

Bionano Genomics (NasdaqCM:BNGO) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker0Today, and welcome to the Bionano Third Quarter 2025 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Kelly Gura from Investor Relations. Please go ahead.Speaker2Thank you, Dee Dee, and good afternoon, everyone. Welcome to the Bionano Genomics Third Quarter 2025 Financial Results Conference Call. Leading the call today is Dr. Erik Holmlin, CEO ...

Biogen (NasdaqGS:BIIB) Conference November 13, 2025 04:30 PM ET Speaker1Good afternoon and welcome once again to TD Cowen's 2025 I&I Summit. I'm Phil Nadeau, one of the biotech analysts here at Cowen, and it's my pleasure to moderate a fireside chat with Biogen. We have with us today Diana Gallagher, who is the Head of Clinical Development of MS, immunology, and Alzheimer's disease at Biogen. Diana, thanks for joining us today. I thought we'd start with maybe a few broad overview questions before diving int ...

Nov 13, 2025 5:10 PM Eastern Standard Time Neurogene Reports Third Quarter 2025 Financial Results and Highlights Recent Updates NEW YORK--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced third quarter 2025 financial results and highlighted recent corporate updates. "We significantly advanced our NGN-401 gene therapy clinical program for Rett syndrome over ...

涉及的行业或公司 * 公司为Travere Therapeutics (NasdaqGM: TVTX) [1] * 行业聚焦于罕见肾脏病领域 特别是局灶节段性肾小球硬化症(FSGS)和IgA肾病(IgAN) [4] 核心观点和论据 FSGS适应症审评与数据 * 公司针对FSGS的补充新药申请(SNDA)的处方药用户费用法案(PDUFA)日期为2025年1月13日 [7] * 在美国肾脏病学会(ASN)上公布的最新数据分析显示 达到0.7克/克尿蛋白肌酐比(UPCR)蛋白尿目标的患者 其长期肾功能衰竭风险降低约85% [5] * 在为期两年的临床试验中 sparsentan（FILSPARI）治疗组与活性对照组相比 治疗效应存在26%的差异 并且与肾功能衰竭风险降低约24%相关 [6] * 公司已请求将适应症范围定为8岁及以上FSGS患者 估计可覆盖患者人群约为30,000人 [21][23] * 与IgAN的上市相比 FSGS上市预计将更快 原因包括医生治疗紧迫感更强 拥有两年完整数据并寻求完全批准 已有支付方覆盖政策基础 以及REMS要求近期已修改 [25][26][27] 监管互动与标签预期 * 公司与FDA心脏肾脏部门的互动具有一致性 审评团队稳定 预计部门主任Eliza Thompson将是本次SNDA的最终签署人 [14] * 公司预计在PDUFA日期前约一个月获得草案标签 并计划在12月初进入静默期 [7][18][19] * 公司请求的适应症标签范围可能包括广泛的FSGS 或仅限于原发性和遗传性FSGS [22][23] IgA肾病市场动态与竞争格局 * 在IgAN领域 FILSPARI需要与新兴的APRIL/BAFF靶点药物联合使用 最新的KDIGO指南也强调了联合治疗的必要性 [34] * 公司对FILSPARI的持续增长充满信心 特别是在蛋白尿水平较低的早期患者中 [35] * 竞争对手Van Rapia的上市目前影响有限 其适应症范围较窄 公司正在积累更多暴露数据 计划在FSGS获批后与FDA讨论完全移除REMS的可能性 [36][37] 财务表现与现金状况 * 公司第三季度末现金余额为2.55亿美元 加上10月收到的里程碑款项 模拟计算后现金余额约为3亿美元 [39] * 公司预计在持续的收入增长下 现有资金足以支持所有当前研发项目 暂无近期融资需求 但尚未达到可指引盈利或现金流产生的阶段 [39] * 公司对名为pegtibatinase的研发项目抱有希望 预计将在明年重新开始患者入组 [40] 其他重要内容 * 公司指出FSGS疾病具有异质性 其他在研机制药物可能仅适用于特定患者亚组 而FILSPARI有望提供更广泛的治疗选择 [31] * 公司提及在IgAN上市初期需要进行大量医生教育 而在FSGS领域 医生对积极治疗的紧迫性有更高认知 [25] * 对于成人FSGS患者 目标用药剂量是IgAN剂量的两倍 预计定价也将相应提高 [28][29]

New York, New York--(Newsfile Corp. - November 13, 2025) - Levi & Korsinsky notifies investors that it has commenced an investigation of Tvardi Therapeutics, Inc. ("Tvardi Therapeutics, Inc.") (NASDAQ: TVRD) concerning possible violations of federal securities laws.On October 13, 2025, Tvardi reported data from its Phase 2 REVERT study testing its STAT3 inhibitor drug, TTI-101, to treat patients with idiopathic pulmonary fibrosis (IPF). The company reported that "the study did not meet its goals," as the " ...

Nov 13, 2025 4:30 PM Eastern Standard Time Vistagen Reports Fiscal Year 2026 Second Quarter Financial Results and Provides Corporate Update Share PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder is Complete; Topline results expected by calendar year end SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and ...

Conditionally Active Biologics: Transforming Cancer Therapy Corporate Presentation November 2025 Important Notices & Disclaimers This presentation (the "Presentation") by BioAtla, Inc. ("we", "us", "our", "BioAtla", or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to statements we make regarding BioAtla's business plans and prospects; whet ...

业绩总结 - 2025年第三季度收入为740万美元，同比增长21%[13] - 核心收入同比增长12%[13] - 非GAAP毛利率为46%，相比于2024年第三季度的26%有显著提升[13] - 非GAAP运营支出为970万美元，同比下降40%[13] - 截至2025年9月30日，公司现金及现金等价物和可供出售证券总额为3180万美元[13] 用户数据 - 销售的流动细胞（Flowcells）数量为8390个，同比增长7%[13] - 新的OGM安装数量为7个，2025年迄今为止总计23个[13] - OGM安装基数达到384个，同比增长4%[13] - 2025年第三季度共发布97篇新研究，较去年同期增长10%[22] - 841个人类临床研究基因组在2025年第三季度发布，同比增长84%[24] 未来展望 - 预计2025年全年收入在2600万至3000万美元之间[30] - 新的OGM安装数量预计超过25个[30]