Biotech Stocks Facing FDA Decision In May 2026

(RTTNews) - In the U.S., May is observed as Mental Health Awareness Month, a tradition that goes back to 1949. About 60 million American adults live with some form of mental illness, ranging from mild anxiety and depression to more severe psychiatric conditions, according to reports.

The theme for this year is "More Good Days, Together," focusing on community support.

Shifting focus to the regulatory landscape, the May FDA calendar appears relatively light.

The upcoming regulatory milestones include a potential label expansion of argenx SE's VYVGART, and an additional indication for Daiichi Sankyo Company and AstraZeneca plc's cancer therapy Enhertu. Also awaiting FDA decisions in May are Eisai's supplemental Biologics License Application for Leqembi iqlik, and a supplemental application from MannKind evaluating Afrezza use in pediatrics.

Let's take a look at the biotech stocks facing the FDA decisions in May 2026.