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.
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