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 ...

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 ...

核心产品VYJUVEK商业表现与全球扩张 - 第三季度VYJUVEK净产品收入为9780万美元，自美国推出以来累计收入达6.232亿美元[1] - 产品毛利率高达96%[3] - 公司已在德国推出VYJUVEK，并于第四季度在法国和日本推出[1][3] - 在美国已获得超过615项报销批准，并成功将适用患者群体扩大至出生即患病的DEB患者，允许患者或护理人员在家自行用药[3] 研发管线进展 - 囊性纤维化治疗药物KB407的CORAL-1研究第三队列中期数据预计在第四季度公布[6] - α-1抗胰蛋白酶缺乏症治疗药物KB408的SERPENTINE-1研究重复给药2B队列中期数据预计在2026年上半年公布[6] - 用于DEB患者角膜擦伤治疗和预防的KB803的III期IOLITE研究预计在年底前完成入组[8] - 神经性角膜炎治疗药物KB801获得FDA平台技术认定，可能提高后续药物开发效率[11] - 用于非小细胞肺癌的吸入式KB707已获得FDA二期会议结束资格，公司计划进行一项三期注册研究，中期疗效数据和潜在注册研究计划预计在2026年下半年公布[10][12] 财务业绩亮点 - 截至2025年9月30日，公司拥有现金、现金等价物和投资总额为8.642亿美元[1][17] - 第三季度净收入为7940万美元，摊薄后每股收益为2.66美元，相比2024年同期的2720万美元和0.91美元有显著增长[23] - 2025年前九个月净产品收入为2.82亿美元，相比2024年同期的1.994亿美元增长8260万美元[23] - 2025财年非GAAP研发及行政费用指导范围为1.45亿至1.55亿美元[20]

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 ...

Data demonstrate efficacy and durability of vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy, are on par with autologous CAR-T cell therapies in the confirmatory cohort (N=22) and with longer-term follow-up on patients who received optimized vispa-cel (N=35) 82% ORR, 64% CR rate, 51% PFS at 12 months in patients prospectively enrolled in partial HLA matching confirmatory cohort (N=22)86% ORR, 63% CR rate, 53% PFS at 12 months in patients who received vispa-cel with an optimized profile (N=35) Vispa-ce ...

Under the theme “Own the Outcome,” the free-to-attend safety seminar provides life-long learning opportunities for a wide cross-section of industry professionalsDynamic seminar brings together more than 400 aviation professionals on site, hundreds more worldwide via webcastJam-packed lineup includes must attend educational seminar sessions highlighting lessons of safety leadership, building a safety culture, reimagining team dynamics and more MONTRÉAL, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Bombardier today ann ...

SHENZHEN, China, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Recently, Geekvape has once again captured worldwide attention with its outstanding R&D capabilities and keen consumer insights. Its latest masterpiece, SOUL II, has been honored with the prestigious 2025 MUSE Design Gold Award, which gathered over 40,000 entries this year. This accolade not only affirms the product’s innovative excellence but also highlights Geekvape’s comprehensive brand strength. Recognized as one of the world’s most influential honors i ...