Exelixis, Inc. (EXEL) announced that the District Court of Delaware has ruled in its favor in the second patent litigation against MSN Laboratories. MSN is seeking approval for its generic product of Exelixis' cabozantinib. Details of EXEL's Patent Litigation Cabozantinib is marketed under the brand name Cabometyx for the treatment of renal cell carcinoma (RCC). EXEL has been involved in a lawsuit with MSN since 2019, when the latter submitted an abbreviated new drug application (ANDA) to the FDA requesting ...

文章核心观点 - 公司与制药巨头Merck签订临床开发合作协议,共同推进管线候选药物zanzalintinib的开发 [1][2][3] - 公司正在努力拓展其肿瘤药物组合和管线,除了其主打药物Cabometyx外,还有多个新药处于临床开发阶段 [4][5][6] 关于zanzalintinib的合作 - 公司将评估zanzalintinib与Merck的PD-1抑制剂Keytruda联合用于治疗头颈鳞状细胞癌的III期临床试验 [2] - 双方还将评估zanzalintinib与Merck的HIF2α抑制剂Welireg联合用于治疗肾细胞癌的I/II期和III期临床试验 [2][3] - Merck将为正在进行的STELLAR-305III期试验提供Keytruda,而公司将负责zanzalintinib的供应 [2][3] Cabometyx的进展 - Cabometyx与Bristol Myers的Opdivo联合用于一线治疗的表现出色,在肝细胞癌适应症上也保持了增长 [4] - 公司正在申请Cabometyx用于治疗胰腺神经内分泌肿瘤和胰外神经内分泌肿瘤的标签扩展,并计划提交联合Tecentriq用于转移性去势抵抗性前列腺癌的申请 [5] 管线拓展计划 - 公司决定终止XB002的开发,将资源重新分配到zanzalintinib的新的关键性试验、XL309的推进以及不断壮大的管线 [6] - 成功开发更多新药将有助于公司减少对Cabometyx的依赖,拓宽产品组合 [6]

文章核心观点 - 公司的主要药物Cabometyx在肾细胞癌和肝细胞癌适应症表现出色,有望进一步扩大适应症 [3][4] - 公司管线进展良好,包括下一代口服酪氨酸激酶抑制剂zanzalintinib和XL309等在研药物 [5][6] - 公司通过股票回购等方式积极回报股东 [7] 根据相关目录分别进行总结 公司业务表现 - 公司股价在过去3个月内上涨20.7%,超过行业6.3%的涨幅,也超过了大盘 [1][2] - Cabometyx是公司的主要收入来源,在肾细胞癌和肝细胞癌适应症表现出色 [3] - 公司正积极推进Cabometyx在胰腺神经内分泌瘤和胰外神经内分泌瘤适应症的拓展 [3] - 公司还计划提交Cabometyx联合Tecentriq用于转移性去势抵抗性前列腺癌的申请 [4] 管线进展 - 公司管线进展良好,包括下一代口服酪氨酸激酶抑制剂zanzalintinib和XL309等在研药物 [5] - 公司计划于2025年上半年启动zanzalintinib的III期临床试验,用于治疗胰腺神经内分泌瘤和胰外神经内分泌瘤 [5] - 公司还计划推进XL309和XB010的I期临床试验,但已决定终止XB002的开发 [5] - 新药物的成功开发将有助于公司减少对Cabometyx的依赖,丰富产品线 [6] 股东回报 - 公司通过股票回购方式积极回报股东,已完成2024年回购计划,累计回购2030万股 [7] - 公司董事会批准了额外的5亿美元股票回购计划,将持续至2025年底 [7]

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