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CareDx(CDNA) - 2025 Q3 - Earnings Call Presentation
2025-11-05 05:30
Q3 2025 Financial Results N O V E M B E R 4 , 2 0 2 5 Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this presentation, including statements regarding the future financial position of CareDx®, Inc. (together with its subsidiaries, "Care ...
Intelligent Bio Solutions Expects to Report Record Fiscal First Quarter 2026 Revenue of Over $1 Million, an Increase of Approximately 32% Sequentially and 28% Year-Over-Year
Globenewswire· 2025-11-04 21:30
Company Achieves Third Consecutive Quarter of Revenue Growth Revenue Increase of Approximately 32% Sequentially and 28% Year-Over-Year Driven by New Customer Accounts and Strong Cartridge and Reader Sales Cartridge and Reader Revenue Up Approximately 43% and 23% Year-Over-Year Respectively NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today anno ...
Exagen Announces Acceptance of Six Abstracts at 2025 American College of Rheumatology Convergence
Globenewswire· 2025-10-23 21:15
CARLSBAD, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, announced today the acceptance of six abstracts at the 2025 American College of Rheumatology’s (ACR) annual meeting, ACR Convergence 2025, being held October 24-29, 2025, at the McCormick Place Convention Center in Chicago, Illinois. Exagen’s featured plenary presentation, in collaboration with Johns Hopkins University, will highlight a urinary biomarker panel that holds the potential to ...
Exagen Inc. to Announce Third Quarter 2025 Financial Results on November 4, 2025
Globenewswire· 2025-10-22 04:05
CARLSBAD, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of innovative autoimmune testing, will release financial results for the quarter ended September 30, 2025, before the market opens on Tuesday, November 4, 2025. John Aballi, Exagen’s President and Chief Executive Officer, and Jeff Black, Chief Financial Officer, will host a conference call to review the company’s results at 8:30 a.m. ET (5:30 a.m. PT). Conference Call & Webcast: U.S. dial-in: 201-389-0918Intern ...
GRAIL PATHFINDER 2 Results Show Galleri ® Multi-Cancer Early Detection Blood Test Increased Cancer Detection More Than Seven-Fold When Added to USPSTF A and B Recommended Screenings
Prnewswire· 2025-10-18 06:08
研究设计与规模 - PATHFINDER 2研究是美国迄今为止规模最大的多癌种早期检测介入性研究,共招募了35,878名参与者[1] - 研究针对50岁及以上、无临床癌症疑似症状的广泛适用人群,是一项前瞻性、多中心介入研究[1][11] - 截至2024年12月31日,对首批25,578名完成至少12个月随访的参与者进行了预设分析,其中23,161名参与者的数据可用于性能分析,25,114名参与者的数据可用于安全性分析[1] 检测性能与有效性 - 在标准护理筛查基础上加用Galleri检测,使癌症检出率提高了七倍以上[2] - Galleri检测出的癌症中,超过半数(53.5%)处于I期或II期早期阶段,超过三分之二(69.3%)处于I-III期[3] - 检测显示癌症信号检出率为0.93%,癌症确诊率为0.57%,阳性预测值达到61.6%[4] - 对于导致美国三分之二癌症死亡的12种癌症,其12个月事件敏感性为73.7%,所有癌症的事件敏感性为40.4%,特异性高达99.6%,假阳性率仅为0.4%[5][6] 临床价值与市场定位 - 约四分之三由Galleri检出的癌症目前没有推荐的标准筛查方案[2] - 癌症信号来源预测准确率达到92%,有助于指导高效的诊断评估,诊断解决中位时间为46天[7] - 该检测是唯一在筛查人群介入性试验中得到验证的多癌种早期检测产品[2] 监管进展与未来计划 - 研究数据将作为Galleri上市前批准申请的一部分提交给美国FDA[8] - 公司预计在2026年上半年完成模块化上市前批准提交,该检测已获得突破性设备认定[8] - 公司管理层将于2025年10月20日举办电话会议和网络直播,向投资界讨论PATHFINDER 2研究结果[9]
Analysts Estimate Neogen (NEOG) to Report a Decline in Earnings: What to Look Out for
ZACKS· 2025-10-02 23:00
Neogen (NEOG) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended August 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on October 9, might help the stock move higher if these key numbers are better than expectations. ...
Safe Supply Streaming Co Ltd. and MDBio Sign U.S. Manufacturing Agreement for ToxiShield Products Amidst Record Federal Overdose Crisis Funding
Newsfile· 2025-09-30 20:17
Safe Supply Streaming Co Ltd. and MDBio Sign U.S. Manufacturing Agreement for ToxiShield Products Amidst Record Federal Overdose Crisis FundingSeptember 30, 2025 8:17 AM EDT | Source: Safe Supply Streaming Co Ltd.Toronto, Ontario--(Newsfile Corp. - September 30, 2025) - Safe Supply Streaming Co Ltd. (CSE: SPLY) (OTCQB: SSPLF) (FSE: QM4) ("Safe Supply" or the "Company") today announced it has entered into a 12-month manufacturing and supply agreement with MobileDetect Bio, Inc. ("MDBio") to sup ...
Intelligent Bio Solutions Advances Preparations and Provides Updated Timeline for Anticipated FDA 510(k) Submission and Clearance
Globenewswire· 2025-09-26 20:30
The Company is initiating clinical studies to further validate Intelligent Fingerprinting Drug Screening System INBS anticipates FDA 510(k) clearance in the second half of 2026 NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today is providing an update on the timeline for anticipated FDA 510(k) clearance for the use of its Intelligent Fingerprinti ...
GRAIL to Present New Galleri® Data From More Than 32,000 Participants Across the PATHFINDER 2, SYMPLIFY and REFLECTION Studies at ESMO Congress 2025 and EDCC
Prnewswire· 2025-09-23 21:01
公司研究数据发布 - GRAIL公司将在2025年10月17-21日于柏林举行的欧洲肿瘤内科学会2025年大会上公布其注册性PATHFINDER 2研究的新数据,重点展示Galleri多癌种早期检测测试的性能和安全性 [1] - PATHFINDER 2研究的第一批结果已被接受为欧洲肿瘤内科学会2025年大会的晚期突破性报告,该结果将作为Galleri上市前批准申请的一部分提交给美国食品药品监督管理局 [1] - 公司还将在早期癌症检测会议上公布SYMPLIFY和REFLECTION研究的更新结果,分别重点展示Galleri测试在有症状人群和退伍军人群体的性能 [1] 产品管线进展 - Galleri是公司研发的多癌种早期检测测试,其使命是在癌症可治愈的早期阶段进行检测 [1] - 公司计划将PATHFINDER 2研究的数据提交给美国食品药品监督管理局,作为Galleri测试上市前批准申请的一部分 [1]
GRAIL Gains Momentum Post-IPO Amid Strong Sales, Partnerships, and Executive Share Activity
Yahoo Finance· 2025-09-20 21:39
公司财务表现 - 2025年第二季度实现营收3550万美元,较上一季度增长11% [2] - 当季度Galleri检测产品销售超过45000份,体现强劲市场需求 [2] - 公司自2024年6月25日IPO以来,股价累计上涨169.02% [3] 业务运营与进展 - 公司与Rush University System for Health等主要医疗系统建立合作伙伴关系 [2] - PATHFINDER 2癌症检测研究取得积极进展 [2] - 公司核心产品Galleri是一种血液检测,利用新一代测序和数据科学技术在症状出现前识别多种癌症类型 [4] 公司治理与股权变动 - 总裁Joshua J Ofman于2025年8月20日出售4202股,总价值134548美元 [3] - 首席财务官Aaron Freidin同期出售877股,总价值28081美元 [3]