Cingulate Inc Stock Price, News & Analysis

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 Inc. (NASDAQ: CING) has appointed Nilay Patel, JD as Chief Legal Officer as the company prepares to submit a New Drug Application (NDA) for its ADHD treatment CTx-1301. Patel brings over 20 years of pharmaceutical industry experience, most recently serving as Chief Legal Officer at Ironshore Pharmaceuticals.

The appointment comes at a crucial time as Cingulate plans to file its NDA for CTx-1301 (dexmethylphenidate HCl) in the coming weeks. The company granted Patel stock options for 30,000 shares at $4.51 per share, vesting over four years with 25% vesting after the first year and the remainder monthly over 36 months.

Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's progress toward commercializing its lead ADHD treatment, CTx-1301. The drug leverages Cingulate's proprietary Precision Timed Release (PTR) platform to provide once-daily stimulant therapy with rapid onset and sustained efficacy, addressing key limitations in current ADHD treatments. CTx-1301 targets the substantial $22B U.S. ADHD market. The company plans to submit its New Drug Application (NDA) in mid-2025, supported by data from nine clinical trials, including successful pediatric and high-dose studies demonstrating strong efficacy, safety, and flexible dosing. Cingulate is simultaneously preparing for U.S. commercialization while exploring international out-licensing opportunities.

Life365 has appointed healthcare veteran Jay Roberts as Chief Development Officer to drive strategic growth and partnerships. Roberts, who previously served as an executive advisor to Life365, brings over 30 years of healthcare leadership experience to the role. In his new position, he will focus on securing funding, building strategic partnerships, and fostering stakeholder relationships to accelerate market expansion.

Roberts currently serves as a partner with Ventac Partners and as a venture partner for DigiLife Fund II. His extensive experience includes CEO, COO, and CFO positions at Nasdaq-traded companies, involvement in over 50 M&A and financing transactions, and board positions at various healthcare companies including Cingulate (CING). He previously served as president and CEO of Vyant Bio and held leadership roles at Cancer Genetics and VirMedica.

Cingulate (NASDAQ: CING) announced positive Phase 3 clinical trial results for CTx-1301 (dexmethylphenidate) in treating ADHD in pediatric patients aged 6-17. The study demonstrated statistically significant improvements in ADHD symptoms across all fixed doses (18.75-mg, 25-mg, and 37.5-mg), achieving effect sizes of 0.737 to 1.185 within 5 weeks. The drug, utilizing Cingulate's proprietary Precision Timed Release™ platform, showed promising results in the randomized, double-blind, placebo-controlled trial. A recent food effect study confirmed CTx-1301 can be taken with or without food, and previous Phase 3 safety data showed consistent safety profiles across eight clinical trials. The company plans to submit a New Drug Application (NDA) this summer, with expectations to launch CTx-1301 in eight dosage strengths, six targeting patients under 18.

Cingulate Inc. (NASDAQ: CING) has received formal pre-New Drug Application (NDA) meeting minutes from the FDA for CTx-1301, its lead ADHD treatment asset. The company plans to submit the NDA this summer following positive feedback from the April 2, 2025 meeting. CTx-1301, a dexmethylphenidate-based medication, is positioned as the first true once-daily stimulant for full-day ADHD treatment.

Key FDA agreements include: post-NDA approval commitment for additional stability data on 6 intermediate dose strengths, expected 24-month shelf-life at launch, adequacy of nonclinical safety data, ability to rely on Focalin XR's efficacy and safety data, and acceptance of the company's approach to integrated safety and efficacy summaries.

Cingulate Inc. (NASDAQ: CING) reported its Q1 2025 financial results and provided key updates on its drug development pipeline. The company completed a Pre-NDA meeting with the FDA for its lead ADHD asset CTx-1301 on April 2, 2025, maintaining its timeline for NDA submission in mid-2025. Recent Phase 3 safety data and food effect studies showed positive results for CTx-1301.

The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103 (buspirone) for anxiety treatment, to be paid in three $1 million installments. As of March 31, 2025, Cingulate had $9.5 million in cash, providing runway into Q4 2025. The company reported a Q1 2025 net loss of $3.8 million, up from $3.0 million in Q1 2024, with R&D expenses at $2.2 million and G&A expenses at $1.5 million.

Cingulate has announced positive top-line results from its high-dose study of CTx-1301, a treatment for ADHD. The study focused on the 50mg dose of their lead candidate, examining how food affects its absorption.

The trial enrolled 27 healthy adults aged 18-50 years, testing the drug both with a high-fat breakfast and on an empty stomach. Key findings show that CTx-1301 can be taken with or without food, though patients should maintain consistency in their dosing approach.

The drug utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology and is designed as the first true once-daily stimulant medication for entire-day ADHD treatment. It offers eight dose strengths for optimal patient customization. The study measured pharmacokinetic parameters including maximum plasma concentration (Cmax) and total drug absorption (AUC), with results showing favorable tolerability and consistent adverse events with previous findings.

Cingulate Inc. (NASDAQ: CING) has secured a $3 million grant from a private foundation to accelerate the development of CTx-2103 (buspirone) for anxiety treatment. The grant will be distributed in three $1 million tranches, with the first payment scheduled for May 1st and subsequent tranches tied to development milestones.

CTx-2103 aims to be the first once-daily formulation of buspirone in the $5.5 billion U.S. anxiety market ($11.6 billion globally). The foundation will receive quarterly royalties of $500,000 after commercialization, capped at $3.5 million total. The development leverages Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform technology.

This initiative addresses a significant medical need, as anxiety disorders affect approximately 31% of U.S. adults and represent the most common mental health concern in America, according to the National Institutes of Mental Health.