Biotech had a strong 2025 with the sector index up about 34%, driven by M&A activity and over 44 FDA approvals. Zacks highlighted three stocks with catalysts coming up in 2026. Denali (DNLI) is waiting on a decision for its Hunter syndrome drug. The FDA extended the deadline to April 5, 2026, to review updated pharmacology info, though it wasn't related to safety issues. Nuvalent (NUVL) had its NDA accepted for a lung cancer treatment. The FDA set a target action date for September 18, 2026. Vanda (VNDA) submitted an application for a psoriasis drug and requested priority review. They also have a decision date set for February 21, 2026, for a separate bipolar disorder treatment.