H.C. Wainwright Reiterates Buy Rating on Cingulate (CING)
H.C. Wainwright analyst Boobalan Pachaiyappan reiterated a Buy rating and $20.00 price target on Cingulate (NASDAQ: CING).
The analyst commented: "Cingulate is actively collaborating with the FDA to provide responses to information requests related to the manufacturing and chemistry, manufacturing and controls (CMC) elements of its 505(b)(2) New Drug Application (NDA) for the company's lead asset CTx-1301, which was assigned a Prescription Drug User Fee Act (PDUFA) approval decision date of May 31, 2026. The company remains committed to working efficiently with the FDA; we remind investors that the agency originally accepted the CTx-1301 NDA for review on October 14, 2025. We continue to consider CTx-1301 an eminently approvable product candidate, given the fact that it is a once-daily, multi-core proprietary tablet formulation of dexmethylphenidate—a compound that has been used to treat attention deficit/hyperactivity disorder (ADHD) for decades. The FDA previously indicated that Cingulate could leverage Focalin XR’s efficacy and safety data on file with the FDA as a basis for approval, together with bioavailability/bioequivalence (BA/BE) data along with efficacy and safety data from the company's CTx-1301 clinical program. In anticipation of timely approval of the CTx-1301 NDA, we reiterate our Buy rating and 12-month price target of $20 per share."
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Shares of Cingulate closed at $4.47 yesterday.
