Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301
Cingulate (NASDAQ: CING) has received a significant PDUFA fee waiver of $4.3 million from the FDA for its upcoming New Drug Application (NDA) for CTx-1301, its lead ADHD treatment asset. The waiver, granted through the small business provision of the FD&C Act, comes just days before the company's planned NDA submission at the end of July 2025.
CTx-1301 (dexmethylphenidate HCI) is developed using Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform technology. The fee waiver will strengthen the company's financial position as it moves toward commercialization of its ADHD treatment candidate.
Cingulate (NASDAQ: CING) ha ottenuto una significativa esenzione dalla tassa PDUFA di 4,3 milioni di dollari dalla FDA per la sua prossima domanda di Nuovo Farmaco (NDA) relativa a CTx-1301, il suo principale trattamento per l'ADHD. L'esenzione, concessa tramite la disposizione per le piccole imprese del FD&C Act, arriva pochi giorni prima della prevista presentazione della NDA da parte dell'azienda, prevista per la fine di luglio 2025.
CTx-1301 (dexmetilfenidato HCI) è sviluppato utilizzando la tecnologia proprietaria di Cingulate, la piattaforma di rilascio del farmaco Precision Timed Release™ (PTR™). Questa esenzione dalla tassa rafforzerà la posizione finanziaria dell'azienda mentre si avvicina alla commercializzazione del suo candidato trattamento per l'ADHD.
Cingulate (NASDAQ: CING) ha recibido una exención significativa de la tarifa PDUFA de 4,3 millones de dólares por parte de la FDA para su próxima Solicitud de Nuevo Medicamento (NDA) para CTx-1301, su principal tratamiento para el TDAH. La exención, otorgada a través de la disposición para pequeñas empresas de la Ley FD&C, se concede pocos días antes de la presentación planificada de la NDA por parte de la compañía a finales de julio de 2025.
CTx-1301 (dexmetilfenidato HCl) se desarrolla utilizando la tecnología de plataforma de administración de fármacos patentada de Cingulate, Precision Timed Release™ (PTR™). La exención de la tarifa fortalecerá la posición financiera de la compañía mientras avanza hacia la comercialización de su candidato para el tratamiento del TDAH.
Cingulate (NASDAQ: CING)는 주력 ADHD 치료제인 CTx-1301에 대한 신약 신청서(NDA)를 위해 FDA로부터 430만 달러 상당의 중요한 PDUFA 수수료 면제를 받았습니다. 이 면제는 FD&C 법의 소규모 기업 조항을 통해 부여되었으며, 회사가 2025년 7월 말에 예정된 NDA 제출을 앞두고 며칠 전 이루어졌습니다.
CTx-1301(덱스메틸페니데이트 HCl)은 Cingulate의 독자적인 Precision Timed Release™ (PTR™) 약물 전달 플랫폼 기술을 사용해 개발되었습니다. 이번 수수료 면제는 ADHD 치료 후보물질의 상업화를 향해 나아가는 회사의 재정적 입지를 강화할 것입니다.
Cingulate (NASDAQ : CING) a obtenu une exonération significative des frais PDUFA de 4,3 millions de dollars de la FDA pour sa prochaine demande de nouveau médicament (NDA) concernant le CTx-1301, son principal traitement contre le TDAH. Cette exonération, accordée dans le cadre de la disposition pour les petites entreprises de la loi FD&C, intervient quelques jours avant la soumission prévue de la NDA par la société à la fin juillet 2025.
CTx-1301 (dexmethylphénidate HCl) est développé en utilisant la technologie propriétaire de plateforme d'administration de médicaments Precision Timed Release™ (PTR™) de Cingulate. Cette exonération des frais renforcera la position financière de la société alors qu'elle s'oriente vers la commercialisation de son candidat traitement contre le TDAH.
Cingulate (NASDAQ: CING) hat von der FDA eine bedeutende PDUFA-Gebührenbefreiung in Höhe von 4,3 Millionen US-Dollar für seinen bevorstehenden Antrag auf Zulassung eines neuen Medikaments (NDA) für CTx-1301, sein führendes Medikament gegen ADHS, erhalten. Die Befreiung, die durch die Kleinunternehmensregelung des FD&C-Gesetzes gewährt wurde, erfolgte nur wenige Tage vor der geplanten NDA-Einreichung des Unternehmens Ende Juli 2025.
CTx-1301 (Dexmethylphenidat HCl) wird mit Cingulates proprietärer Precision Timed Release™ (PTR™)-Technologie zur Wirkstofffreisetzung entwickelt. Die Gebührenbefreiung wird die finanzielle Position des Unternehmens stärken, während es auf die Kommerzialisierung seines ADHS-Behandlungs-Kandidaten zusteuert.
- Secured $4.3 million FDA fee waiver, strengthening financial position
- Imminent NDA submission for lead ADHD asset CTx-1301
- Proprietary PTR drug delivery platform technology demonstrates development capabilities
- Company requires small business waivers, indicating limited financial resources
PDUFA Fee Waiver comes Days before Planned Submission of New Drug Application
KANSAS CITY, Kan., July 29, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for lead asset CTx-1301 (dexmethylphenidate HCI) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save Cingulate approximately
“We are pleased to receive this significant waiver as we approach the submission of our NDA in the coming days and look forward to continuing to work with the FDA throughout the submission and review process,” said Cingulate Chairman and CEO Shane J. Schaffer. “This waiver will save Cingulate more than
About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, OralogiK™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Investor & Media Relations:
Thomas Dalton
Vice President, Corporate Communications, Cingulate
tdalton@cingulate.com
(913) 942-2301
FAQ
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