Cingulate (CING) announced that it has received formal pre-New Drug Application meeting minutes from the FDA for its lead asset CTx-1301 for the treatment of Attention Deficit/Hyperactivity Disorder. The agency agreed to a post-NDA approval commitment of additional stability date for the 6 intermediate dose strengths. The available data for nonclinical safety appears adequate to support a filing.
"We are pleased that the feedback we received from our pre-NDA meeting with the FDA is aligned with our plans to submit a new drug application for CTx-1301 this summer. Today we are one step closer to bringing to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day," said Cingulate Chairman and CEO Shane Schaffer.
Shares of Cingulate are down 2% in pre-market trade on Wednesday.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
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.