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) reported first quarter 2026 results and progress toward commercializing lead ADHD candidate CTx-1301.
Cash and equivalents rose to $25.9 million, with working capital at $17.0 million, aided by a $12.0 million private placement. Management believes this supports operations into 2027 while engaging with the FDA on the CTx-1301 NDA and building AI-augmented commercial and manufacturing capabilities.
Q1 2026 net loss was $9.3 million, driven mainly by higher G&A expenses and non-cash derivative and interest items.
Cingulate (NASDAQ: CING) updated 4Q25 coverage as Stonegate Capital Partners highlighted progress toward a potential commercial launch of CTx-1301. The NDA remains under FDA review via the 505(b)(2) pathway with feedback focused on manufacturing/CMC, not safety or efficacy.
Following a $12M PIPE in Feb 2026, Cingulate has a pro forma cash balance of ~$23M, which is estimated to provide runway into late 2026; the company also has ATM and ELOC access. The Company discloses a ~1% market share implies ~$250M revenue potential targeting the booster-dose ADHD segment.
Cingulate (NASDAQ: CING) reported Q4 and full-year 2025 results and operational milestones on March 18, 2026, including a U.S. Notice of Allowance and a European patent for CTx-1301, acceptance of the NDA with a PDUFA date of May 31, 2026, and a closed $12M at-the-market PIPE.
Financials show approximately $11.0M cash as of Dec 31, 2025, a $22.4M net loss for 2025, and working capital of $1.7M; the company expects cash to fund operations into late Q4 2026 under its current plan.
Cingulate (NASDAQ: CING) closed a $12.0 million at-the-market PIPE financing priced at the Nasdaq closing price of $5.04 per share on January 26, 2026, led by affiliates of Falcon Creek Capital.
Investors agreed to a 180-day lock-up, the deal includes 80% warrant coverage, convertible preferred stock that accrues 12% annualized interest, and warrants with a three-year term; Falcon Creek may designate up to two board members.
Cingulate (NASDAQ: CING) updated 3Q25 progress as it advances CTx-1301 toward a potential commercial ADHD launch. Key developments include FDA acceptance of the CTx-1301 NDA with a May 31, 2026 PDUFA date, presentation of positive pediatric Phase 3 data showing rapid onset and full active‑day symptom control, and an exclusive U.S. supply agreement with Bend Bio Sciences to secure manufacturing capacity.
Commercial build continues with a new Chief Commercial Officer, an Indegene partnership, quarter‑end cash of ~$6.1M, and a post‑quarter $6M financing that the company says extends runway into 2Q26.
Cingulate (NASDAQ: CING) reported Q3 2025 results and corporate updates on Nov 13, 2025.
Key items: the FDA accepted the NDA for CTx-1301 with a PDUFA date of May 31, 2026; positive Phase 3 results were presented at AACAP; a commercial supply agreement with Bend Bio Sciences was executed; a $6.0M financing via a non‑convertible promissory note was completed; and a $4.3M PDUFA fee waiver was granted. As of Sept 30, 2025, cash was $6.1M, working capital $1.55M, and net loss for Q3 was $7.34M. The company projects cash runway into Q2 2026 and plans to raise ~$7.0M to advance commercialization.
Cingulate (NASDAQ: CING) appointed Bryan Downey as Chief Commercial Officer and announced FDA acceptance of its New Drug Application for CTx-1301 with a PDUFA date of May 31, 2026. The company completed a $6.0 million financing via a $6,570,000 unsecured promissory note carrying 9% interest and maturing in 18 months, which the company says extends cash runway into Q2 2026. Downey received 30,000 inducement stock options at a $3.80 exercise price, vesting over four years. Cingulate is preparing commercial infrastructure with partner Indegene, pending FDA approval.
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.