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Giấy phép số 4978/GP-TTĐT do Sở Thông tin và Truyền thông Hà Nội cấp ngày 14 tháng 10 năm 2019 / Giấy phép SĐ, BS GP ICP số 2107/GP-TTĐT do Sở TTTT Hà Nội cấp ngày 13/7/2022.
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Cingulate’s 4Q25 update continued to position CTx-1301 toward a potential commercial launch for attention-deficit/hyperactivity disorder (ADHD), with the regulatory focus now centered on manufacturing (CMC) rather than clinical performance. The company stated that its NDA remains under FDA review under the 505(b)(2) pathway. Recent financing, intellectual property progress, and commercial buildout efforts were cited as supportive of the broader investment thesis.
Following the completion of a $12M PIPE in February 2026, Cingulate reported a pro forma cash balance of approximately $23M. The update suggests this level of liquidity provides runway into late 2026. In addition, the company’s ongoing access to capital through its ATM and ELOC facilities is expected to support continued regulatory and manufacturing activities as it works toward resolution of remaining CMC items.
According to the update, FDA feedback has been limited to manufacturing and CMC considerations, with no safety or efficacy concerns raised. This framing implies that remaining work is more closely related to process validation rather than clinical risk.
The company’s commentary also indicates that while regulatory timing may shift, approval remains likely, with any delay attributed to manufacturing validation rather than fundamental issues with the product profile.
After the $12M PIPE completed in February 2026, Cingulate’s pro forma cash balance is approximately $23M. Combined with continued access to capital through its ATM and ELOC facilities, the company is positioned to fund ongoing regulatory and manufacturing activities through the period leading into late 2026.
The update highlighted a large ADHD market opportunity for CTx-1301. It cited that a ~1% market share could imply roughly $250M in revenue potential, with the product primarily targeting the booster-dose segment, as disclosed by the company.

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