Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
CING Catalyst Timeline
Dated clinical, regulatory and corporate events for Cingulate Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Cingulate Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How CING actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-02 | CTx-1301 (dexmethylphenidate) | PDUFA Date CRL | PDUFA |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CTx-1301- Dexmethylphenidate Small moleculeCompletedNCT05631626 | ADHD | Phase 3 | COMPLETED | 129 | Jun 13, 2023 |
Clinical Trial Results
Readouts, endpoints and source filings for every CING program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| CTx-1301 | attention-deficit/hyperactivity disorder (ADHD) | Phase 3 | 2026-07-30 | p values: 18.75 mg 0.018, 25 mg 0.011, 37.5 mg 0.001; placebo adjusted effect sizes: 18.75 mg 0.737, 25 mg 0.782, 37.5 mg 1.185; overall mean effect size: 0.901Read More | Cingulate Announces Publication of Phase 3 ADHD Trial Results in Journal of Child and Adolescent PsychopharmacologyRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Silva Raul R.Officer (EVP and CSO) | Grant/Award | 3,885 3,885 held | $0.00 | 06/30/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in CING
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in CING for Q2 2026. | ||||
CING Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How CING ranks across every disease it competes in
CING News
Shane Schaffer, Cingulate Chairman & CEO to Present “SMART Launch” Approach at Indegene Digital Summit: Rethinking Commercialization for Emerging Pharma
Cingulate Inc. announced that CEO Shane Schaffer will present at the Indegene Digital Summit on September 22, 2026. The discussion will focus on innovative commercialization strategies for emerging pharma, particularly regarding their lead asset, CTx-1301, aimed at treating ADHD. The company is addressing the challenges of traditional commercialization models and preparing for potential market entry despite recent regulatory hurdles.
Read more →Cingulate Inc. Reports Second Quarter 2026 Financial Results and Provides Update on CTx-1301 CMC Progress Towards NDA Resubmission and Commercial Readiness
Cingulate Inc. reported its financial results for Q2 2026 and provided updates on CTx-1301, its lead ADHD treatment. The company is progressing towards NDA resubmission after receiving a Complete Response Letter from the FDA. Cingulate has also secured a patent for CTx-1301, enhancing its intellectual property. Despite a net loss increase, the company is focused on commercialization preparations.
Read more →Cingulate Publishes Peer-Reviewed Data Demonstrating CTx-1301’s Differentiated Pharmacokinetic Profile
Cingulate Inc. has published peer-reviewed data in CNS Drugs, highlighting the pharmacokinetic profile of its ADHD treatment candidate, CTx-1301. The study indicates that CTx-1301 offers a unique once-daily dosing regimen with three distinct releases of medication. This publication follows a Phase 3 study that confirmed its efficacy and safety, establishing a strong scientific foundation for the product.
Read more →Cingulate Announces Publication of Phase 3 ADHD Trial Results in Journal of Child and Adolescent Psychopharmacology
Cingulate Inc. announced the publication of Phase 3 trial results for CTx-1301 in the Journal of Child and Adolescent Psychopharmacology. The study demonstrated significant improvements in ADHD symptoms with a favorable safety profile. This publication supports the efficacy of CTx-1301 and highlights the potential of Cingulate's Precision Timed Release platform technology. The results are now available through open access.
Read more →Cingulate Inc. (NASDAQ: CING) Added to Russell 3000E®
Cingulate Inc. has been added to the Russell 3000E Index, marking a significant milestone for the company. CEO Shane J. Schaffer highlighted that this inclusion will improve visibility among institutional investors and support long-term growth. The company is advancing its ADHD product candidate, CTx-1301, utilizing its Precision Timed Release technology.
Read more →Cingulate Issued First U.S. Patent for Lead ADHD Asset CTx-1301
Cingulate Inc. has announced the issuance of its first U.S. patent for CTx-1301, a treatment for ADHD. The patent, effective until December 2042, protects the formulation and method of use of CTx-1301, enhancing the company's intellectual property position. This development supports Cingulate's goal of commercializing its proprietary Precision Timed Release technology, which aims to provide effective symptom control throughout the day.
Read more →Cingulate Receives Complete Response Letter from FDA for CTx-1301
Cingulate Inc. announced that the FDA issued a Complete Response Letter for its NDA for CTx-1301, a treatment for ADHD. The letter focused on Chemistry, Manufacturing, and Controls (CMC) requests without raising safety or efficacy concerns. The company plans to address these requests promptly and is well-capitalized with nearly $30 million available for resubmission efforts.
Read more →Cingulate Inc. Reports First Quarter 2026 Financial Results and Provides an Update of Commercial Readiness Efforts On Track for lead ADHD Asset
Cingulate Inc. reported its financial results for the first quarter of 2026, boasting a cash position of $25.9 million, attributed to a recent private placement. The company is focused on advancing the commercialization of its lead ADHD asset, CTx-1301, and continues to work closely with the FDA for its NDA submission. Despite an increase in net loss driven by rising administrative costs, Cingulate maintains a positive outlook as it prepares for potential FDA approval and market launch. The strategic use of AI tools and enhancements in manufacturing and distribution are highlighted as key elements of their launch strategy.
Read more →Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted
Cingulate Inc. has reported its financial results for the fourth quarter and full year of 2025, highlighting a significant net loss while making progress on the regulatory front. The company received a patent allowance for its lead ADHD drug, CTx-1301, and closed a $12 million private placement for funding. Additionally, the FDA has accepted the New Drug Application for CTx-1301, signaling potential market opportunities. However, the increase in net losses and reduced cash reserves are notable challenges as the company advances its pipeline.
Read more →Cingulate Announces the Closing of a $12 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Cingulate Inc. has successfully closed a $12 million private placement financing led by Falcon Creek Capital. This financing is seen as a validation of the company's strategy and technology, with insider participation highlighting confidence in its future. The funds will support operations as Cingulate prepares for the commercial launch of its ADHD treatment, CTx-1301, pending FDA approval.
Read more →Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Cingulate Inc. reported its third quarter 2025 financial results, highlighting the FDA's acceptance of its NDA for CTx-1301, a new ADHD treatment, with a PDUFA date set for May 31, 2026. The company appointed Bryan Downey as Chief Commercial Officer and completed a $6 million financing. Positive Phase 3 results were also presented at a recent conference, although the company reported a net loss of $7.3 million and a decrease in cash reserves.
Read more →Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301
Cingulate Inc. has appointed Bryan Downey as Chief Commercial Officer to lead the launch preparation for CTx-1301, following the FDA's acceptance of its New Drug Application. The company has also secured $6 million in financing to bolster its cash position as it prepares for commercialization. CTx-1301 aims to provide effective ADHD symptom control with a single daily dose.
Read more →Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control
Cingulate Inc. announced positive Phase 3 results for CTx-1301, a treatment for pediatric ADHD, showing significant improvements in ADHD symptoms. The study demonstrated rapid onset and sustained efficacy with once-daily dosing, which could enhance patient adherence. The FDA accepted the New Drug Application for CTx-1301, targeting a potential approval by May 2026.
Read more →Cingulate’s Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting
Cingulate Inc. announced that its lead ADHD candidate, CTx-1301, has been selected for a podium presentation at the AACAP Annual Meeting. The presentation will focus on the efficacy and safety of CTx-1301, a once-daily formulation aimed at improving treatment for ADHD. This recognition underscores the scientific interest in the drug's potential benefits for patients.
Read more →FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date
Cingulate Inc. announced that the FDA has accepted its New Drug Application for CTx-1301, a treatment for ADHD. The FDA set a PDUFA date of May 31, 2026, marking a crucial regulatory milestone. CTx-1301 aims to improve ADHD management with its once-daily dosing and rapid onset of effect, supported by positive Phase 3 trial results.
Read more →Cingulate Secures Exclusive Manufacturing Partnership with Bend Bio Sciences to Support Future Commercialization of Next Generation ADHD Treatment
Cingulate Inc. has announced a commercial supply agreement with Bend Bio Sciences to manufacture CTx-1301, its lead ADHD treatment. This partnership ensures that Bend will be the exclusive manufacturer of CTx-1301 in the U.S. through 2028, contingent on FDA approval. The agreement aims to enhance manufacturing capabilities and prepare for market entry following the recent NDA submission.
Read more →Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights
Cingulate Inc. announced its second quarter 2025 financial results and highlighted the submission of a New Drug Application (NDA) for its lead asset CTx-1301, designed to improve ADHD treatment. The FDA is expected to decide on the NDA acceptance by Q4 2025, with a potential PDUFA date in mid-2026. Despite facing a net loss of $4.8 million for the quarter, the company has reported positive clinical results from its studies. Cingulate also secured a capital agreement to support its future pre-commercial activities.
Read more →Cingulate Provides Management Team Update
Cingulate Inc. has appointed Jennifer Callahan as interim CEO following the administrative leave of Shane J. Schaffer due to unrelated legal matters. Jay Roberts has been named Executive Chairman, bringing extensive experience to support the management team. The company remains focused on its mission to develop CTx-1301 for ADHD treatment and is committed to operational stability.
Read more →Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301
Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment. This novel formulation aims to provide fast onset and entire active-day efficacy with a single dose. The company anticipates feedback from the FDA within 60 days of submission, marking a pivotal step in its transition to a commercial organization.
Read more →Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301
Cingulate Inc. announced it has received a $4.3 million waiver from the FDA for its NDA submission of CTx-1301, an ADHD treatment. This waiver, granted under the small business provision, enhances the company's financial standing as it prepares for commercialization. CTx-1301 utilizes a novel drug delivery platform to improve treatment efficacy.
Read more →