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Cingulate Inc.

CING
OvervaluedPharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$4.93
▲ +0.05 · +1.02%

Financials

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52W LOW $3.1652W HIGH $11.89
Volume
12.27 K
Value Traded
651.79 K
Short % Float
9.64%
+3.15%Week
-5.76%1 Month
0%3 Month
-14.76%6 Month
-99.63%5 Year
-99.63%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
71.69 M
EPS (TTM)
-2.00
P/E Ratio
-
Ent. Value
42.56 M
Total Shares
14.54 M
Float Shares
12.14 M
Insiders
16.53%
Institutions
12.71%

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 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

CING Catalyst Timeline

Dated clinical, regulatory and corporate events for Cingulate Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Cingulate Inc.

224Total events
5Upcoming
53Tier-1 (high impact)
2021 to 2027Coverage

Upcoming catalysts 2

T2Runway Guidance Update
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Event history 50

●Quarterly UpdateCorporate
Q2 2026 financial results reported
▲PublicationCTx-1301FiledPresentation
Phase 3 results published in Journal of Child and Adolescent Psychopharmacology
▲Partnership / LicenseCTx-1301FiledCorporate
Exclusive services agreement with Prasco, LLC for commercial distribution
▲Quarterly UpdateCorporate
Cingulate added to Russell 3000E Index
▲Patent GrantedCTx-1301FiledIP / Competition
US Patent No. 12,653,791 issued covering CTx-1301
▼Complete Response LetterCTx-1301FiledFDA Decision
FDA issued Complete Response Letter for CTx-1301 NDA
Attention Deficit/Hyperactivity Disorder (ADHD)source ↗
●IND SubmissionCTx-2103IND
IND submission for CTx-2103 targeted for mid-2026
anxietysource ↗
▼Complete Response LetterCTx-1301FiledFDA Decision
FDA issued Complete Response Letter for the CTx-1301 NDA
●PDUFA DateCTx-1301FiledRegulatory Filing
FDA assigned PDUFA target action date of May 31, 2026 for CTx-1301 NDA
●Quarterly UpdateCorporate
Q1 2026 financial results reported
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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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 %
2026-06-02CTx-1301 (dexmethylphenidate) PDUFA Date CRLPDUFA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D37 / 100
Pipeline Score
$25M
Pipeline Value
Overvalued
Valuation Signal
1
Drugs Scored
0.4x
rNPV / MCap
Top 47%
Micro Cap
(rank 310 of 658)
Percentile Rank
Cingulate Inc. faces pipeline headwinds (37/100), with $1.4B risk-adjusted pipeline value, led by CTx-1301- Dexmethylphenidate in ADHD (Phase 3).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
CTx-1301- Dexmethylphenidate Small moleculeCompletedNCT05631626ADHDPhase 3 COMPLETED 129Jun 13, 2023
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Clinical Trial Results

Readouts, endpoints and source filings for every CING program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
CTx-1301 attention-deficit/hyperactivity disorder (ADHD)Phase 32026-07-30p 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 MoreCingulate Announces Publication of Phase 3 ADHD Trial Results in Journal of Child and Adolescent PsychopharmacologyRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Silva Raul R.Officer (EVP and CSO)Grant/Award 3,885 3,885 held$0.00 06/30/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in CING for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

CING Institutional Ownership Trends

Options Data

Option Volume

Open Interest
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OI 30-day avg
Today vs avg
Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How CING ranks across every disease it competes in

Competitive Position is a premium feature
See how CING ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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CING News

CING
Sep 17, 2026
CINGConferences/Events

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 →
CING
Aug 13, 2026
CINGFDA Updates

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.

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CING
Aug 11, 2026
CINGPhases

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.

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CING
Jul 30, 2026
CINGPhases
▲ +5.2%on this news

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.

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CING
Jul 2, 2026
CINGGeneral
▼ -8.7%on this news

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.

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CING
Jun 16, 2026
CINGFDA Updates

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.

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CING
Jun 2, 2026
CINGFDA Updates
▲ +11.9%on this news· ran to +36% by day 1

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.

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CING
May 14, 2026
CINGFDA Updates
▼ -10.8%on this news

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.

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CING
Mar 18, 2026
CINGGeneral
▼ -31%on this news

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.

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CING
Feb 17, 2026
CINGGeneral

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.

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CING
Nov 13, 2025
CINGFDA Updates
▼ -12.4%on this news

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.

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CING
Nov 10, 2025
CINGFDA Updates

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 →
CING
Oct 28, 2025
CINGPhases

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.

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CING
Oct 23, 2025
CINGConferences/Events
▲ +7.8%on this newsshared move

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.

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CING
Oct 14, 2025
CINGFDA Updates

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.

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CING
Sep 17, 2025
CINGGeneral
▼ -5.9%on this news

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.

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CING
Aug 19, 2025
CINGFDA Updates
▼ -9.6%on this news

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.

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CING
Aug 15, 2025
CINGGeneral

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.

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CING
Aug 6, 2025
CINGFDA Updates
▼ -16.6%on this news

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.

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CING
Jul 29, 2025
CINGFDA Updates

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.

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About Cingulate Inc.

Kansas City, KS 14 employees cingulate.com
Headquarters1901 W. 47TH PLACE, KANSAS CITY, KS, 66205
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