Welcome to our dedicated page for Cingulate news (Ticker: CING), a resource for investors and traders seeking the latest updates and insights on Cingulate stock.
Cingulate Inc. reports clinical, regulatory, intellectual property and financing developments tied to its Precision Timed Release™ drug-delivery platform. The clinical-stage biopharmaceutical company is focused on once-daily, multi-core tablet formulations for central nervous system conditions, led by CTx-1301 (dexmethylphenidate HCl) for attention deficit/hyperactivity disorder.
Company news commonly covers CTx-1301 data presentations, FDA interactions under the 505(b)(2) pathway, patent activity in the United States and Europe, commercial supply and launch-preparation arrangements, quarterly financial results, private placements, at-the-market financing capacity, and governance or executive updates.
Cingulate (NASDAQ: CING) announced the FDA has accepted the New Drug Application for CTx-1301 (dexmethylphenidate) for ADHD with a PDUFA date of May 31, 2026. The NDA was filed under the FDA’s 505(b)(2) pathway after completion of adult and pediatric Phase 3 trials and all FDA-requested studies.
Phase 3 data showed rapid onset and sustained daily efficacy across multiple measures in adults and children (ages 6+); no serious treatment-emergent adverse events were reported. Cingulate reports completed commercial-scale manufacturing transfer with Bend Bio Sciences and early payer receptivity for a once-daily product.
Cingulate (NASDAQ: CING) has secured an exclusive commercial manufacturing partnership with Bend Bio Sciences for CTx-1301, its lead ADHD treatment candidate. The agreement extends through 2028 and positions CTx-1301 for commercial launch, pending FDA approval.
The partnership follows Cingulate's NDA submission to the FDA on July 31, 2025 for CTx-1301, a novel extended-release dexmethylphenidate formulation utilizing the company's Precision Timed Release™ (PTR™) technology. Under the agreement, Bend Bio Sciences will be the exclusive U.S. manufacturer, with Cingulate committing to purchase 100% of its commercial supply from Bend following potential FDA approval.
Cingulate (NASDAQ: CING) has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment asset utilizing Precision Timed Release™ technology. The company expects an FDA decision on NDA acceptance in Q4 2025, with a potential PDUFA date in mid-2026.
Key Q2 2025 financial results show cash position of $8.9 million, expected to last into late 2025. The company needs an additional $1.5 million for commercialization efforts. Q2 net loss widened to $4.8 million from $3.2 million year-over-year, with R&D expenses increasing 43.6% to $2.7 million. Cingulate secured a $25 million purchase agreement with Lincoln Park Capital over 36 months to support pre-commercial activities.
Cingulate (NASDAQ: CING) announced significant management changes as Chairman and CEO Shane J. Schaffer has been placed on administrative leave due to legal matters unrelated to the company. Jennifer Callahan, the company's CFO, has been appointed as interim CEO while maintaining her CFO duties. Additionally, board member Jay Roberts has been named Executive Chairman.
The company recently submitted a new drug application to the FDA in July for CTx-1301, their ADHD treatment candidate. The management team includes experienced executives Dr. Matt Brams (Co-Founder and CMO), Dr. Raul Silva (Co-Founder and CSO), and Nilay Patel (CLO).
Cingulate Inc. (NASDAQ: CING) has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment candidate. The drug, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) platform, is designed to provide once-daily dosing with fast onset and entire active-day efficacy.
CTx-1301 is a novel extended-release formulation of dexmethylphenidate HCl that aims to address major limitations of current ADHD therapies. The company expects to receive notification of NDA acceptance within 60 days of its July 31 submission. The drug targets the $23 billion U.S. ADHD market and represents the first regulatory application of Cingulate's PTR™ platform technology.
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.
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 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.