First clinical data disclosure for CB-011 highlights its potential as a best-in-class allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma450 million cell dose is the recommended dose for expansion (RDE); dose expansion to initiate by year end and data expected in 202692% ORR, 75% ≥CR rate, 91% MRD negativity in the 12-patient, BCMA-naïve cohort treated at the RDE with the selected lymphodepletion regimenConference call and webcast scheduled for today at 8:00 am ET BERKELEY, Calif., Nov ...

Xanadu Produced the First Networked, Modular and Scalable Quantum Computer with their Aurora System in Early 20251First Pure Play Quantum Computing Company to Achieve Quantum Supremacy with their Borealis System in 2022 Xanadu’s PennyLane Software Offering is the #1 Quantum Programming Software with 47% Usage Among Quantum Programmers2Pro Forma Enterprise Value of the Combined Company is Expected to be Approximately US$3.1 Billion and Pro Forma Market Capitalization is Expected to be Approximately US$3.6 Bi ...

First successful end-to-end on-wing calls already completed. Gogo begins flight testing next-generation 5G ATG connectivity on Pilatus PC-24 jet MB-13 antennas equipped to belly of the fuselage connect with the Gogo 5G tower network Broomfield, CO., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Gogo (NASDAQ: GOGO) has begun flight testing its next-generation 5G air-to-ground connectivity network for North American customers. Optimizing a Pilatus PC-24 trials platform, the test team is flying on alternate days during ...

On 5 May 2025, Schouw & Co. initiated a share buy-back programme as outlined in Company Announcement no. 20 of 2 May 2025. Under the programme, Schouw & Co. will acquire shares for up to DKK 120 million during the period 5 May to 31 December 2025. The buy-back will be structured in accordance with Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (MAR) and the Commission’s delegated regulation (EU) 2016/1052 of 8 March 2016 (“Safe Harbour” rules). Tr ...

临床试验数据 - 在39名晚期非鳞状非小细胞肺癌患者中，lifileucel单药一次性治疗的客观缓解率为25.6%，观察到10例客观缓解，包括2例完全缓解和7例部分缓解，疾病控制率为71.8% [3] - 中位随访25.4个月后，中位缓解持续时间尚未达到 [3] - 与初始方案相比，采用更新的减少非清髓性淋巴细胞清除方案的患者的白细胞介素-2治疗后中位住院天数减少超过一半，且血细胞减少的发生率更低、缓解时间更短 [6] 监管与商业化进展 - 美国食品药品监督管理局已对IOV-LUN-202试验设计和支持注册的效力测定矩阵提供了积极的监管反馈 [4] - 该试验设计符合FDA关于在未满足医疗需求的条件下支持加速批准的单臂试验指南 [4] - IOV-LUN-202试验预计将于2026年推进lifileucel在非鳞状非小细胞肺癌领域的补充生物制剂许可申请，并可能在2027年下半年上市 [4] 市场背景与竞争格局 - 肺癌是全球诊断最普遍的癌症和癌症死亡的主要原因，每年全球估计有250万新病例和180万死亡病例，美国每年估计有22.6万新病例和12.5万死亡病例 [8] - 约85%的肺癌病例为非小细胞肺癌，其中非鳞状非小细胞肺癌估计占非小细胞肺癌病例的75% [9] - 在先前接受过免疫检查点抑制剂和化疗的非鳞状非小细胞肺癌患者中，标准护理多西他赛单药治疗的客观缓解率为12.8%，中位缓解持续时间为5.6个月，总生存期为12.3个月，且无完全缓解 [5] 公司技术与平台 - Iovance Biotherapeutics是一家商业化的生物技术公司，专注于创新、开发和提供用于癌症患者的新型多克隆肿瘤浸润淋巴细胞疗法 [2] - 肿瘤浸润淋巴细胞疗法旨在重振和扩增患者的肿瘤浸润淋巴细胞，使其能够被部署来对抗癌症 [12] - 该公司的Amtagvi是首个获得FDA批准的用于实体瘤适应症的T细胞疗法 [13]

Total 3Q 2025 net product revenue of $171.0 million, representing 63% year-over-year growth AUVELITY® 3Q 2025 net product sales of $136.1 million, representing 69% year-over-year growth SUNOSI® 3Q 2025 net product revenue of $32.8 million, representing 35% year-over-year growth SYMBRAVO® 3Q 2025 net product sales of $2.1 million sNDA for AXS-05 in Alzheimer’s disease agitation submitted to the FDA Company to host conference call today at 8:00 AM Eastern NEW YORK, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Axsome The ...

$97.8 million in 3Q VYJUVEK revenue and $623.2 million since U.S. launch VYJUVEK launched in Germany in 3Q; launched in France and Japan in 4Q Updated U.S. VYJUVEK label expands eligible patient population and provides greater patient flexibility FDA grants platform technology designation CF interim results expected in 4Q Strong balance sheet, ending the quarter with $864.2 million in cash and investments PITTSBURGH, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) to ...

PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR® Transcatheter Heart Valve (THV) in patients ...

Acquisition to Accelerate Revenue, Adjusted EBITDA, and Free Cash Flow Growth and will be Accretive to Adjusted EBITDA Margins and Free Cash Flow ConversionST. GALLEN, Switzerland, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Sportradar Group AG (NASDAQ: SRAD) (“Sportradar” or the “Company”) today announced it has completed its acquisition of IMG ARENA and its global sports betting rights portfolio from Endeavor Group Holdings, Inc. and OB Global Holdings, LLC. The closing marks a milestone in Sportradar’s growth stra ...

Identification of Radville Focus Area 375 km Southeast of First Well at Lawson Redraws the Genesis Map and Further Strengthens MAX Power’s Leadership in the Natural Hydrogen Sector MAX Power Saskatchewan Natural Hydrogen Documentary Videohttps://www.maxpowermining.com/NaturalHydrogen-NewEra/ SASKATOON, Saskatchewan, Nov. 03, 2025 (GLOBE NEWSWIRE) -- MAX Power Mining Corp. (CSE: MAXX; OTC: MAXXF; Frankfurt: 89N) (“MAX Power” or the “Company”) is pleased to announce a major extension of the Genesis Trend wit ...