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Biotech Stocks Facing FDA Decision In May 2026

AstraZeneca
AstraZeneca

On May 18, 2026, Daiichi Sankyo and AstraZeneca plc (AZN) anticipate a decision from the FDA regarding the approval of Enhertu for an expanded indication.

The proposed use involves Enhertu followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer.

Discovered by Daiichi Sankyo, Enhertu is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The drug is already approved in many countries around the world, including the U.S., for treating different types of advanced breast cancer in adults, as well as gastric cancer, non-small cell lung cancer, and solid tumors.

AZN closed Monday's trading at $187.51, down 1.18%