Taiho Oncology, Taiho Pharmaceutical And Cullinan Therapeutics initiate rolling submission of new drug application to US FDA

Reuters
2025.11.20 12:20
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Nov 20 (Reuters) - Cullinan Therapeutics Inc:TAIHO ONCOLOGY, TAIHO PHARMACEUTICAL AND CULLINAN THERAPEUTICS INITIATE ROLLING SUBMISSION OF NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR ZIPALERTINIB FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EGFR EXON 20 INSERTION MUTATIONSTAIHO ONCOLOGY INC: ANTICIPATE COMPLETION OF NDA SUBMISSION IN Q1 2026 WITH ASSOCIATED REQUEST FOR PRIORITY REVIEW Source text: Further company coverage:

Nov 20 (Reuters) - Cullinan Therapeutics Inc (CGEM.O) :

  • TAIHO ONCOLOGY, TAIHO PHARMACEUTICAL AND CULLINAN THERAPEUTICS INITIATE ROLLING SUBMISSION OF NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR ZIPALERTINIB FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EGFR EXON 20 INSERTION MUTATIONS
  • TAIHO ONCOLOGY INC: ANTICIPATE COMPLETION OF NDA SUBMISSION IN Q1 2026 WITH ASSOCIATED REQUEST FOR PRIORITY REVIEW Source text: Further company coverage: (CGEM.O)
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