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Stock impact report

Merck's Priority Review Cancer Drug Adds To Undervalued Growth Story [Yahoo! Finance]

DAIICHI SANKYO S/ADR (DSNKY) 
Company Research Source: Yahoo! Finance
U.S. FDA accepts and grants Priority Review for the Biologics License Application for ifinatamab deruxtecan. The application covers treatment of adult patients with extensive stage small cell lung cancer who have received at least one prior systemic therapy. If approved, ifinatamab deruxtecan could become the first B7-H3 directed therapy in this setting. The therapy is being co-developed by Merck (NYSE:MRK) and Daiichi Sankyo. For investors tracking NYSE:MRK, this Priority Review highlights an expansion effort beyond the company's existing oncology portfolio into small cell lung cancer, where treatment options remain limited. The product is an antibody drug conjugate targeting B7-H3, a different approach from many current therapies and one that fits with broader interest in targeted biologics across oncology. The FDA's decision to grant Priority Review shortens the review clock, which can bring regulatory clarity sooner than a standard review. For those following Merck, thi Show less Read more
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