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) received its first U.S. patent fully owned for lead ADHD candidate CTx-1301, issued June 16, 2026 as U.S. Patent No. 12,653,791.
The patent covers formulation and method-of-use claims, extending U.S. protection for CTx-1301’s trimodal Precision Timed Release™ tablet technology through December 2042.
Stonegate Capital Partners updated coverage on Cingulate (NASDAQ:CING) after the FDA issued a Complete Response Letter (CRL) for the CTx-1301 NDA. According to Cingulate, the CRL focuses on specific CMC information requests with no current clinical safety or efficacy concerns identified.
The near-term path shifts from a PDUFA-timed approval to a CMC-driven resubmission process, requiring completion of the requested work and a new review cycle. Cingulate disclosed nearly $30M in cash, which management believes is sufficient to address FDA requests, resubmit, and support pre-commercial activities into 2027.
Cingulate (NASDAQ:CING) received a Complete Response Letter from the FDA for its NDA for CTx-1301 for ADHD. The FDA outlined specific Chemistry, Manufacturing and Controls (CMC) information requests and did not currently identify clinical safety or efficacy concerns. Cingulate plans a prompt resubmission and reports nearly $30 million in cash, which it believes is sufficient to address the FDA’s requests and support pre-commercial activities into 2027.
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.