Cingulate Inc. (CING), a biopharmaceutical company, on Tuesday said the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CTx-1301, the company's lead candidate for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026 for the application.
The NDA submission follows the completion of adult and pediatric Phase 3 trials, all FDA-requested studies, and a positive pre-NDA meeting in April 2025, which confirmed that the clinical and Chemistry, Manufacturing, and Controls (CMC) data packages are adequate for review.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.