Cingulate Stock Price, News & Analysis

Cingulate (NASDAQ: CING) reported positive Phase 3 results for CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD on Oct 28, 2025. The trial met its primary endpoint (p < 0.001), showed dose-dependent improvements on ADHD-RS-5 and CGI-S, and delivered rapid onset with sustained symptom relief up to 12 hours post-dose. The 37.5 mg dose produced the largest effect size. Safety and tolerability were consistent with the stimulant class with no unexpected adverse events. The FDA accepted the New Drug Application in October 2025 with a target PDUFA date of May 31, 2026, and Cingulate received a small-business PDUFA fee waiver saving approximately $4.3 million. Cingulate has a variable-cost commercial partnership with Indegene and plans additional scientific and investor disclosures.

Cingulate (NASDAQ: CING) announced that Phase 3 data for its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) was selected for a podium presentation at the AACAP Annual Meeting in Chicago.

Dr. Ann Childress will present “Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD” on October 24, 2025. The session will be livestreamed and results will be summarized in a follow-up company announcement after the conference.

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.