This market will resolve to No if the FDA's decision is a denial (CRL issued), a withdrawal by the sponsor, or a conditional approval — or if no decision is issued.

Zidesamtinib (also known by its development code NVL-520) is an experimental cancer medicine made by Nuvalent Inc. that is designed to fight a specific type of lung cancer driven by a faulty molecular switch called ROS1. Think of ROS1 as a car's accelerator pedal stuck in the "floored" position — it keeps cancer cells growing uncontrollably — and zidesamtinib acts like a clamp that holds the pedal back, slowing or stopping that runaway growth. It is a small-molecule drug, meaning it is taken as a pill and can travel throughout the body, including into the brain, where ROS1-driven lung cancers commonly spread.