Shane Schaffer, Cingulate Chairman and CEO, Provides Update on CTx-1301 in Interview with Innovators with Jane King
Key Highlights
- ➤Cingulate plans to resubmit CTx-1301’s NDA after completing FDA-requested CMC work
- ➤FDA issued a Complete Response Letter for CTx-1301’s NDA on June 1, 2026
- ➤CTx-1301 uses three timed releases for once-daily ADHD treatment
- ➤Cingulate is preparing commercialization plans for potential CTx-1301 launch
Expert Statements
Shane J. Schaffer, Chairman and CEO of Cingulate
“We recognize that our shareholders have been waiting patiently for a meaningful update on CTx-1301, and we sincerely thank them for their continued support, confidence, and commitment to Cingulate as we complete the work addressing the items in the FDA’s Complete Response.”
KANSAS CITY, Kan., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products, announced today that Chairman and CEO Shane J. Schaffer has provided an update on the regulatory progress of CTx-1301(dexmethylphenidate HCl), the company’s lead asset for the treatment of attention deficit/hyperactivity disorder (ADHD).
In an interview airing this morning on Innovators with Jane King, Dr. Schaffer discusses the company’s ongoing efforts to address the FDA’s Complete Response regarding the CTx-1301 New Drug Application (NDA), progress made to date, and the anticipated timeline for NDA resubmission.
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