newsfilter
← Latest News
GlobeNewswire·

Shane Schaffer, Cingulate Chairman and CEO, Provides Update on CTx-1301 in Interview with Innovators with Jane King

  • Cingulate Inc. (NASDAQ: CING) announced that Chairman & CEO Shane J. Schaffer provided an update on regulatory progress for lead asset CTx-1301 (dexmethylphenidate HCl) for ADHD treatment.
  • Schaffer discussed addressing the FDA's Complete Response Letter regarding the CTx-1301 New Drug Application (NDA) in an interview on "Innovators with Jane King."
  • The company plans to complete requested CMC work & resubmit the NDA as promptly as practicable after the FDA issued the Complete Response Letter on June 1, 2026.
  • Chief Commercial Officer Bryan Downey & Schaffer recently presented commercialization strategies at the Indegene Digital Summit, covering a "Smart Launch" approach & "Reinventing the Launch Playbook."
  • CTx-1301 is a once-daily, multi-core tablet utilizing the Precision Timed Release™ (PTR™) platform to deliver three precise timed releases of medication.
  • The drug is being evaluated under the FDA's 505(b)(2) pathway; the original PDUFA target action date was May 31, 2026.
  • The PTR™ platform uses an Erosion Barrier Layer (EBL) licensed from BDD Pharma to control drug release times without prior release.
  • Cingulate intends to expand its pipeline beyond ADHD & anxiety disorders using its PTR technology to address conditions with burdensome daily dosing regimens.
  • The company is headquartered in Kansas City, Kan., & provides contact information for media & investors via Thomas Dalton, Vice President of Corporate & Government Relations.
Company
Cingulate Inc.
Keywords
Nasdaq:CINGW, Cingulate Inc., NDA resubmission, Cingulate, CING, CTx-1301, PTR™, Precision Timed Release™, Bloomberg News, Dow Jones, WSJ, NDA Acceptance