Otsuka reported its phase 3b ADHD trial met its primary endpoint, strengthening the company’s case ahead of an expected U.S. regulatory decision. The positive readout arrives shortly before a potential approval timeline that would set up an eventual launch window for the investigational therapy. For Otsuka, the near-term focus will be on aligning the phase 3b findings with the FDA’s expectations on benefit-risk and patient subgroups, as well as preparing for post-approval execution. The company’s timing suggests it views the results as leverage for the remaining regulatory steps.