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KANSAS CITY - The U.S. Food and Drug Administration has accepted for review Cingulate Inc.’s (NASDAQ:CING) New Drug Application for CTx-1301, a once-daily dexmethylphenidate treatment for Attention-Deficit/Hyperactivity Disorder in children and adults, the company announced Tuesday. The clinical-stage biopharmaceutical company, currently valued at $22.7 million, shows a strong balance sheet with more cash than debt, according to InvestingPro data.
The FDA assigned a Prescription Drug User Fee Act target action date of May 31, 2026, according to a press release statement from the biopharmaceutical company. While analysts maintain a bullish stance with price targets ranging from $8 to $62, InvestingPro data indicates the company is rapidly burning through cash.
CTx-1301 is being reviewed under the FDA’s 505(b)(2) regulatory pathway, which allows Cingulate to reference existing data on previously approved active ingredients while demonstrating clinical benefits through its proprietary Precision Timed Release drug-delivery platform.
The application follows completion of adult and pediatric Phase 3 trials. In clinical studies, CTx-1301 demonstrated improvements in ADHD symptoms with rapid onset and sustained efficacy throughout the day. No serious treatment-emergent adverse events were reported, and the tolerability profile was consistent with other long-acting methylphenidate products.
"CTx-1301 was engineered to address the practical shortcomings of today’s stimulant therapies—multiple daily dosing, midday rebound, and adherence challenges—through a single, once-daily tablet," said Cingulate Executive Chairman Jay Roberts.
The company stated it is advancing commercial readiness activities in preparation for potential launch. Cingulate has completed process transfer and scale-up production through its manufacturing partnership with Bend Bio Sciences, and has established a commercial partnership with Indegene.
ADHD affects an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults, according to the company. With current EBITDA at -$17.21 million, investors seeking deeper insights into Cingulate’s financial health and growth prospects can access additional analysis through InvestingPro, which offers 8 more exclusive tips about the company’s performance.
In other recent news, Cingulate Inc. has secured a commercial supply agreement with Bend Bio Sciences for the manufacturing of its lead ADHD treatment candidate, CTx-1301. This agreement positions Bend Bio Sciences as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, contingent upon FDA approval. Additionally, Cingulate has reported a series of unregistered sales of equity securities, issuing a total of 325,729 shares of its common stock between late July and August to settle portions of debt owed to a lender.
In a significant leadership change, Cingulate’s board of directors appointed John A. Roberts as Executive Chairman while placing CEO Shane Schaffer on administrative leave due to a criminal charge. Jennifer Callahan, the company’s Chief Financial Officer, has been appointed as interim CEO, maintaining her CFO responsibilities. Meanwhile, Ascendiant Capital has raised its price target for Cingulate to $62, maintaining a Buy rating, indicating potential upside for investors. These developments highlight a period of strategic and operational shifts for Cingulate.
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