5 Key Takeaways

• 1

  Cingulate's CTx-1301 received a Complete Response Letter from the FDA regarding its New Drug Application for ADHD treatment.

• 2

  The FDA's feedback focused on Chemistry, Manufacturing and Controls requests, with no current concerns about clinical safety or efficacy.

• 3

  Cingulate plans to submit the requested information to the FDA, with related CMC work already in progress.

• 4

  CTx-1301 is designed as a once-daily, multi-core tablet for timed release of dexmethylphenidate throughout the day.

• 5

  The FDA accepted the NDA for review in October 2025, with a target action date of May 31, 2026, but CTx-1301 remains investigational.