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Cingulate nearly done with manufacturing fixes for ADHD drug CTx-1301 ahead of NDA resubmission

🇺🇸 Cingulate Inc. (CING) · Fri 13 Nov 2026

The US company expects to resubmit its dexmethylphenidate application between December 2026 and January 2027, after FDA raised manufacturing questions in a June complete response letter.

Cingulate said on 13 November 2026 that it has substantially completed the manufacturing work needed to respond to the FDA's chemistry, manufacturing and controls (CMC) information requests for CTx-1301 (dexmethylphenidate HCl), its candidate for attention deficit hyperactivity disorder (ADHD). The requests were set out in a Complete Response Letter dated 1 June 2026.

The company expects to resubmit the new drug application between December 2026 and January 2027. The FDA would then designate the filing as either a Class 1 or Class 2 resubmission, which carry review goals of two and six months respectively.

Cingulate also reported third-quarter 2026 results. It held $23.2 million in cash and posted a net loss of $7.7 million for the quarter. The company said its cash runway extends into mid-2027.

For context, a complete response letter is issued when the FDA concludes it cannot approve an application in its current form. The sponsor must address the stated deficiencies in a resubmission before a new review clock starts.

What it means for your team

  • A resubmission window of December 2026 to January 2027 means the FDA's classification, Class 1 or Class 2, will determine whether a decision is due in about two or six months.
  • The CMC-focused response shows manufacturing and quality questions can hold up an otherwise advanced application, so sponsors should plan for them early.
  • Cash runway into mid-2027 sits close to the likely review period, so timing of the FDA's decision matters for the company's financing.

Company's press release (SEC filing): Cingulate Inc. ↗

Article written by VigiEye from the official source (Cingulate Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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