CTx-1301 (dexmethylphenidate)

Note: CRL, explicitly stated by the company. Cingulate filed an 8-K dated 2026-06-02 (accession 0001493152-26-026760, Items 7.01/8.01/9.01) announcing the FDA issued a Complete Response Letter for the CTx-1301 (dexmethylphenidate HCl) NDA in ADHD — two days after the 2026-05-31 PDUFA target action date. The quoted evidence is from Item 8.01 of the 8-K body itself; the same language appears in the attached press release, Exhibit 99.1 (https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/ex99-1.htm), headlined "Cingulate Receives Complete Response Letter from FDA for CTx-1301 / No Clinical Safety or Efficacy Concerns Currently Identified / Agency Feedback Primarily Focused on CMC-Related Requests". CEO Shane J. Schaffer: "We are encouraged that the FDA's response was limited to specific information requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301... we have nearly $30 million in cash reserves, which we believe provides sufficient capital to address the issues raised and execute on the resubmission process and continue pre-commercial activities into 2027." FDA acted 2026-06-02 (target was 2026-05-31). Source: https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/form8-k.htm