Cingulate close to refiling ADHD drug CTx-1301, with cash lasting into mid-2027

Cingulate's route to market for its ADHD candidate CTx-1301 (dexmethylphenidate HCl) now depends on two things: how the FDA classifies a refiled application, and how long the company's cash lasts. On 13 November the company said it had substantially finished the manufacturing work needed to answer the agency's questions, and it plans to resubmit between December 2026 and January 2027.

The questions concern chemistry, manufacturing and controls (CMC). They were set out in a letter dated 1 June 2026, in which the FDA declined to approve the application as filed. Cingulate did not say in the material available what the specific deficiencies were.

Once the refiling is in, the FDA will treat it as either a Class 1 or a Class 2 resubmission, with review goals of two and six months respectively. Applying those goals to the company's filing window implies a decision in roughly February or March 2027 under Class 1, or around mid-2027 under Class 2. That is our arithmetic, not company guidance.

In its third-quarter results, Cingulate reported $23.2 million in cash and a net loss of $7.7 million for the quarter. It said its cash runway extends into mid-2027, which is close to the later of those possible decision dates.