Summit stock jumps as FDA grants fast track tag for lung cancer therapy

seekingalpha10-04

Summit Therapeutics (NASDAQ:SMMT) shares rose as much as 25% in premarket trading on Friday after the company secured FDA’s Fast Track designation for the proposed use of its cancer drug, ivonescimab,...

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HARMONi is designed with dual primary endpoints of progressi","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"AKESF":"AKESO INC.","SMMT":"Summit Therapeutics PLC","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","BK4139":"生物科技"},"translate_title":"FDA授予肺癌治疗快速通道标签，Summit股价上涨","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AKESF":0.9,"SMMT":0.9},"content_text":"Summit Therapeutics (NASDAQ:SMMT) shares rose as much as 25% in premarket trading on Friday after the company secured FDA’s Fast Track designation for the proposed use of its cancer drug, ivonescimab, in combination with platinum-based chemotherapy for the treatment of advanced lung cancer. The combination therapy is intended for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation in adults, who have experienced disease progression following EGFR-tyrosine kinase inhibitor therapy. Ivonescimab, an investigational bispecific antibody, was engineered by Akeso (OTCPK:AKESF) and is currently engaged in multiple Phase III clinical trials. As part of a license deal signed in 2022, Summit (SMMT) began the clinical development of ivonescimab in non-small cell lung cancer, commencing enrollment in 2023 in two multi-regional Phase III studies, HARMONi and HARMONi-3, with a plan to initiate HARMONi-7 in early 2025. HARMONi is designed with dual primary endpoints of progression-free survival and overall survival, with topline data expected in mid-2025. 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