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 second quarter 2026 results and updates on CTx-1301 regulatory, IP and commercialization activities. Cash and cash equivalents were $28.4 million at June 30, 2026, with working capital of $21.6 million; the company expects this to fund operations into mid‑2027 under its current plan.
Cingulate continues Chemistry, Manufacturing and Controls (CMC) work with its manufacturing partner to support resubmission of the CTx-1301 NDA following a June 1, 2026 FDA Complete Response Letter that requested additional CMC information but did not raise clinical safety or efficacy concerns. A new U.S. patent (No. 12,653,791) covering CTx-1301 extends protection through December 2042.
Commercial readiness efforts include process validation manufacturing with Bend Bioscience, an exclusive U.S. distribution agreement with Prasco, and commercialization support under agreements with Indegene and IQVIA. Q2 2026 R&D expenses declined 44.9% year over year to $1.5 million, while SG&A more than doubled to $3.9 million, contributing to a net loss of $5.9 million for the quarter and $15.2 million for the first half of 2026.
Cingulate (NASDAQ: CING) reported publication of a peer-reviewed study, “Comparative Bioavailability of Trimodal CTx-1301 Versus Bimodal Dexmethylphenidate,” in the journal CNS Drugs. The open-access paper presents pharmacokinetic, bioavailability, safety, and tolerability data for CTx-1301, the company’s lead ADHD product candidate based on its Precision Timed Release™ (PTR™) platform.
In a randomized crossover study in adults with ADHD, CTx-1301 delivered rapid early dexmethylphenidate exposure comparable to a marketed bimodal formulation, then maintained statistically higher plasma concentrations later in the dosing interval, with a controlled decline designed to reduce late-day “wear-off.” CTx-1301 also showed fewer treatment-emergent adverse events than the comparator despite greater total dexmethylphenidate exposure. According to Cingulate, this publication, together with an earlier Phase 3 efficacy and safety paper, builds a peer-reviewed scientific foundation for CTx-1301 and further validates the PTR trimodal drug-delivery approach.
Cingulate (NASDAQ: CING) announced that Phase 3 trial results for its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) have been published via open access in the Journal of Child and Adolescent Psychopharmacology. The peer-reviewed article describes a randomized, double-blind, placebo-controlled, fixed-dose study in children and adolescents aged 6–17 with ADHD.
According to Cingulate, all three CTx-1301 dose groups (18.75 mg, 25 mg, 37.5 mg) showed improvement versus placebo in the primary endpoint, ADHD Rating Scale-5 score change at Week 5, with p-values of 0.018, 0.011, and 0.001 and placebo-adjusted effect sizes of 0.737, 0.782, and 1.185, respectively. The mean effect size across the study population was 0.901. Investigators reported clinically meaningful symptom improvements with a favorable safety profile, supporting CTx-1301 as a once-daily treatment candidate and reinforcing the potential of Cingulate’s Precision Timed Release™ platform, which delivers three timed medication releases across the day and is also being developed for anxiety and other conditions.
Cingulate (NASDAQ:CING), a biopharmaceutical company developing next‑generation therapies with its Precision Timed Release™ (PTR™) platform, announced inclusion in the Russell 3000E® Index effective June 2026 reconstitution.
Management expects greater visibility with institutional investors as it advances lead ADHD candidate CTx‑1301 and other PTR-based products.
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.
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) 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) 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.