Takeda And HUTCHMED Announce New Drug Application For Fruquintinib For Treatment Of Previously Treated Metastatic Colorectal Cancer Granted Priority Review
Portfolio Pulse from Happy Mohamed
Takeda (TAK) and HUTCHMED (HCM) announced that the FDA has granted priority review for their New Drug Application (NDA) for fruquintinib, a treatment for previously treated metastatic colorectal cancer. The Prescription Drug User Fee Act (PDUFA) goal date for the NDA is November 30, 2023.

May 25, 2023 | 8:32 pm
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POSITIVE IMPACT
HUTCHMED's fruquintinib, developed in partnership with Takeda, has been granted FDA priority review for treating metastatic colorectal cancer.
The FDA granting priority review for HUTCHMED's fruquintinib is a positive development for the company, as it indicates the drug has potential to address an unmet medical need. This could lead to faster approval and commercialization, benefiting HUTCHMED's stock in the short term.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 50
POSITIVE IMPACT
Takeda's fruquintinib, developed in partnership with HUTCHMED, has been granted FDA priority review for treating metastatic colorectal cancer.
The FDA granting priority review for Takeda's fruquintinib is a positive development for the company, as it indicates the drug has potential to address an unmet medical need. This could lead to faster approval and commercialization, benefiting Takeda's stock in the short term.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 50