Safe Harbor and Forward-Looking Statements In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully launching CRENESSITY; our financial and operating performance, inc ...

Conquering Cancer with Data Q2 2025 Earnings Call July 30, 2025 Safe harbor and non-GAAP disclosures Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of th ...

NEW YORK, July 30, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Capricor Therapeutics, Inc. (NASDAQ: CAPR). Shareholders who purchased shares of CAPR during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/capricor-loss-submission-form/?id=158625&from=3 CLASS PERIOD: October ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 30, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), announced today that its second quarter 2025 financial results will be released before market open on August 6, 2025. MannKind will host a webcast beginning at 9:00 a.m. Eastern Time to discuss the financial results and provide a business update. The webcast will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be ...

REDWOOD CITY, Calif., July 30, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that it will report financial results for the second quarter of 2025 on Wednesday, August 6, 2025, after market close. At 4:30 p.m. ET that day (1:30 p.m. PT), members of Revolution Medicines’ senior management team will host a webcast to discuss the financial results for the quarter and ...

SAN FRANCISCO, July 30, 2025 (GLOBE NEWSWIRE) -- On July 18, 2025, investors saw the price of their shares in Sarepta Therapeutics, Inc. (NASDAQ: SRPT) collapse again – this time, shares closed down $7.89 (-36%) - after the company reported the death of a third patient who was being treated with one of its experimental gene therapy drugs. The development comes in the wake of a securities class action styled Dolgicer v. Sarepta Therapeutics, Inc., et al., No. 1:25-cv-05317 (S.D.N.Y.), which seeks to represen ...

**行业与公司** - **公司**：Nkarta Therapeutics (NKTX)，专注于开发用于B细胞介导自身免疫性疾病的同种异体CAR NK细胞疗法[1][2] - **行业**：细胞治疗领域，特别是自身免疫疾病（如狼疮性肾炎、系统性红斑狼疮等）[2][6] --- **核心观点与论据** 1. **平台技术优势** - **CAR NK vs. CAR T**： - **安全性**：CAR NK无高级别细胞因子释放综合征（CRS）或神经毒性（ICANS），而CAR T存在此类风险[4][11] - **便捷性**：同种异体“现货型”疗法，无需患者白细胞分离术，可门诊给药，提升可及性[5][14] - **持久性**：NK细胞作用后快速清除（约1个月内），避免长期存留导致的潜在风险[12][13] 2. **临床项目进展** - **NKX019**：靶向CD19的CAR NK细胞疗法，含膜结合IL-15以增强活性[6] - **适应症**：狼疮性肾炎（LN）、原发性膜性肾病、系统性硬化症等5项IND研究[6][23] - **试验设计**：剂量递增阶段，评估安全性、B细胞耗竭及免疫重置效果[24][25] - **淋巴清除方案调整**：从单用环磷酰胺改为联合氟达拉滨，以优化B细胞耗竭效果[27][28] 3. **差异化与市场机会** - **自身免疫疾病潜力**：相比肿瘤，B细胞负荷更低，CAR NK可能更易实现免疫重置[21][22] - **门诊治疗前景**：安全性支持社区医院应用，突破CAR T对专科中心的依赖[68][70] - **竞争格局**：避开CAR T扎堆的肿瘤领域，聚焦自身免疫病未满足需求[20][47] --- **其他重要内容** 1. **数据预期** - **2025年下半年**：公布NKX019初步数据（安全性、B细胞耗竭等）[51][52] - **2026年**：计划更多患者随访及适应症扩展[75][76] 2. **财务与运营** - **现金储备**：3.5亿美元，预计支撑至2029年[72][73] - **战略聚焦**：2025年重组后专注自身免疫领域，裁员1/3以延长现金流[71] 3. **潜在风险与挑战** - **疗效标准**：需证明持久缓解（如1-2年无复发）以改变临床实践[42][43] - **监管路径**：参考Caballetta案例，可能需15例患者注册试验[62][63] --- **关键数据引用** - **安全性**：40例肿瘤患者中无高级别CRS或ICANS[21] - **财务**：Q1现金3.5亿美元[72] - **临床**：NK细胞清除周期约1个月[12] （注：部分问答因技术问题未完整记录[58][59]）

Cardiff Oncology (NASDAQ: CRDF ) is a company I've been following for quite some time now, and back in May , I prepared an article going over an anticipated data readout. This upcoming presentation ofI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in ...

Key Takeaways Alvotech is set to report Q2 results, with revenues estimated at $115.4M and a 26-cent loss per share.Investors await U.S. sales updates on Simlandi and Selarsdi, launched in 2024 and Q1 2025, respectively.ALVO's pipeline includes AVT05, AVT06 and AVT03; multiple filings under regulatory review in the US and EU.Alvotech (ALVO) , a commercial-stage company developing and manufacturing biosimilar medicines for patients worldwide, is expected to announce its second-quarter 2025 earnings results n ...

财务数据和关键指标变化 - 公司第二季度总营收达到7.99亿美元，同比增长12%，连续12个季度实现两位数同比增长 [12] - Tyvaso DPI产品营收创纪录达3.15亿美元，同比增长22% [12][13] - 公司年度运营现金流接近15亿美元 [9] - 董事会授权10亿美元股票回购计划 [10] 各条业务线数据和关键指标变化 - Tyvaso DPI患者发货量和总Tyvaso系列均创纪录 [13] - Orenitram营收和患者发货量均创纪录 [14] - Remodulin需求保持强劲，患者发货量位列历史前五 [14] - 公司预计今年晚些时候推出新一代Remunity Pro泵 [14] 公司战略和发展方向和行业竞争 - 公司战略分为基础业务、创新浪潮和革命浪潮三个增长阶段 [7][8] - 针对Liquidia竞争产品，公司详细比较了Tyvaso DPI在剂量、耐受性、颗粒沉积和使用便利性方面的优势 [15][16][17] - 公司正在开发每日一次口服前列腺素和新型Tyvaso设备组合 [44] - 器官开发项目预计2030年左右开始产生收入 [44] 管理层对经营环境和未来前景的评论 - 管理层认为近期股价错位提供了特别有吸引力的投资机会 [10] - 对即将到来的IPF和PAH催化剂充满信心 [11] - 预计基础业务将持续增长，同时推进创新小分子管线 [11] - 认为TPIP产品在IPF领域短期内不会构成威胁 [41][42][43] 其他重要信息 - 公司新推出管线网站pipeline.unither.com [9] - 计划参加多个行业会议包括世界移植大会等 [6] - TETON-2研究预计9月公布数据，TETON-1预计2026年公布数据 [11][25][26] 问答环节所有的提问和回答 问题: Utopia产品对Tyvaso DPI的影响及海外Tyvaso nebulized下滑原因 - 回答表示竞争产品上市影响符合预期，医生出于好奇会尝试新产品，但长期看好Tyvaso DPI的产品特性和市场经验 [53][54][55] 问题: TETON试验中FVC下降变异性的控制方法 - 回答指出通过中央读取和严格的现场培训来减少变异性 [62][63] 问题: INCREASE研究中IPF亚组数据的可推广性 - 回答解释treprostinil通过多种受体机制发挥作用，不仅限于血管舒张功能 [69][70] 问题: 股票回购计划的考虑因素 - 回答表示基于商业实力、资产负债表、催化剂信心和股价潜力做出回购决定 [72][73] 问题: TETON研究中IPF患者合并PAH的比例 - 回答说明研究设计未专门测量PAH情况 [78] 问题: Ralinepag机会和研究设计 - 回答指出研究把握度为80%检测0.65风险比，预计年底达到临床恶化事件数 [84] 问题: TETON研究中咳嗽导致揭盲的可能性 - 回答表示安慰剂组也会出现咳嗽，不认为会导致揭盲 [90][91] 问题: IPF研究中背景治疗的影响 - 回答指出TETON研究中背景治疗使用率约75-77%，与FibroNir IPF研究相似 [103][104]