CING Jul 2, 2026CINGGeneral
▼ -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, 2026CINGFDA 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, 2026CINGFDA Updates
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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, 2026CINGFDA 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 CTx-1301 Cash Position Grows to $25.9 Million
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, 2026CINGGeneral
▼ -31%on this news
Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights U.S. Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted Recent $12M Private Placeme
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, 2026CINGGeneral
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, 2025CINGFDA 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, 2025CINGFDA 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.
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CING Oct 28, 2025CINGPhases
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, 2025CINGConferences/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, 2025CINGFDA 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, 2025CINGGeneral
▼ -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, 2025CINGFDA Updates
▼ -9.6%on this news
Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301 Anticipate FDA Decision in Q4 2025 regarding NDA Accepta
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, 2025CINGGeneral
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, 2025CINGFDA 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, 2025CINGFDA 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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CING Jul 9, 2025CINGGeneral
Cingulate Appoints Nilay Patel as Chief Legal Officer to Support Growth ahead of New Drug Application
Cingulate Inc. has appointed Nilay Patel as Chief Legal Officer to facilitate its upcoming new drug application for CTx-1301, aimed at treating ADHD. Patel brings over two decades of legal experience in the pharmaceutical sector, with a focus on drug development and commercialization. The company is leveraging its Precision Timed Release technology to enhance ADHD treatment options, anticipating significant growth in the ADHD market. Patel's onboarding is seen as pivotal for the company's strategic direction as they prepare for regulatory submissions.
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CING May 8, 2025CINGFDA Updates
Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held
Cingulate Inc. reported its financial results for Q1 2025, highlighting a productive meeting with the FDA regarding the NDA for its ADHD treatment CTx-1301, slated for submission by mid-2025. The company also secured a $3 million grant to support the development of CTx-2103 for anxiety management. However, it experienced an increased net loss and a reduction in working capital, raising some concerns about its financial health. Overall, the updates suggest a strategic advancement in Cingulate's product pipeline despite the financial challenges faced.
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CING Apr 29, 2025CINGPhases
Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD
Cingulate Inc. announced positive results from its CTx-1301-013 study, evaluating the effects of food on the absorption of its lead ADHD treatment, CTx-1301, at a 50mg dose. The study confirmed that the medication can be taken with or without food, indicating its favorable pharmacokinetics and tolerability. This formulation aims to provide continuous efficacy throughout the active day, addressing a significant need in ADHD treatment. Full study results will be presented at an upcoming medical meeting.
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CING Apr 9, 2025CINGGeneral
Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone) CTx-2103 has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most
Cingulate Inc. has secured a $3 million grant from a private foundation to expedite the development of CTx-2103 (buspirone) aimed at treating anxiety disorders. This funding will be released in three installments, supporting the goal of creating the first once-daily formulation of buspirone. The grant reflects the foundation's commitment to addressing rising health concerns around anxiety, a critical issue for many patients. CTx-2103 is expected to improve treatment options in a market valued at $5.5 billion in the U.S. alone.
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CING Apr 3, 2025CINGFDA Updates
Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301
Cingulate Inc. has successfully held a Pre-NDA meeting with the FDA regarding its new drug application for CTx-1301, a Phase 3 asset intended to treat ADHD. The meeting was described as productive, and the company remains on schedule for an NDA filing in mid-2025. Recent safety data from multiple clinical trials indicate that CTx-1301 maintains a consistent safety profile. The drug aims to provide patients with an innovative, once-daily dosing solution for ADHD treatment.
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CING Mar 26, 2025CINGFDA Updates
Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-20
Cingulate Inc. released its financial results for the year ending December 31, 2024, showcasing substantial improvements in working capital and cash reserves. The company reported successful results from the final Phase 3 trials of its ADHD treatment, CTx-1301, and confirmed a scheduled Pre-NDA meeting with the FDA for April 2. Cingulate aims to submit its New Drug Application in mid-2025, hoping to market the first once-daily stimulant for ADHD by extending its dosing duration throughout the active day. However, the company is facing an accumulated deficit of over $108 million, despite advances in its clinical pipeline.
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CING Mar 4, 2025CINGPhases
Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025 Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2 CTx-1301
Cingulate Inc. has announced positive results from its final Phase 3 trials for CTx-1301, a new ADHD treatment. The safety data has been submitted to the FDA ahead of a pre-New Drug Application meeting set for April 2, 2025. Notably, the safety profile remained consistent across multiple trials, showing no serious treatment-related adverse events. If approved, CTx-1301 would be the first true once-daily stimulant medication aimed at treating ADHD throughout the entire active day.
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CING Jan 7, 2025CINGFDA Updates
▼ -5.4%on this news
Final Study Completed for Cingulate's Lead Asset CTx-1301 No Serious Adverse Events Reported Submission of New Drug Application Targeted for Mid 2025
Cingulate Inc. has concluded its final FDA-required food effect study for its lead asset, CTx-1301, targeting ADHD treatment. The study involved administering a 50mg dose to assess the drug's effectiveness in both fed and fasted states. Importantly, no serious adverse events were reported, and results regarding the bioavailability of the medication are anticipated in the second quarter of 2025. The company is aiming for a New Drug Application submission to the FDA by mid-2025, which represents a significant milestone in its product development timeline.
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CING Dec 23, 2024CINGGeneral
▲ +16.1%on this news
Cingulate Completes Financing Transaction for Net Proceeds of $5,000,000 Cash Runway Extended Beyond Planned NDA Submission of CTx-1301
Cingulate Inc. has successfully completed a financing transaction that resulted in net proceeds of $5 million. The funds, raised through a promissory note, are intended for working capital and will allow the company to support clinical, manufacturing, and regulatory initiatives through the fourth quarter of 2025. Moreover, Cingulate is targeting a mid-2025 submission for the NDA for CTx-1301, leveraging its proprietary Precision Timed Release technology aimed at enhancing treatment for patients with ADHD and potentially other conditions.
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CING Nov 7, 2024CINGFDA Updates
Cingulate Reports Third Quarter 2024 Financial Results Reflecting $19.5 Million Increase in Working Capital to Advance ADHD Drug to Market On Target for Mid-2025 New Drug Application (NDA) Submission of lead ADHD asset C
Cingulate Inc. reported its financial results for Q3 2024, showing a substantial increase in working capital by $19.5 million as they advance their lead ADHD asset, CTx-1301, towards a New Drug Application (NDA) submission planned for mid-2025. The company has also received European patents for CTx-1301, increasing its market potential. They commenced a final required FDA study for the drug, with data expected by the end of 2024. Additionally, other financial indicators such as cash reserves and a decrease in liabilities reflect a stronger fiscal position.
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CING Oct 8, 2024CINGGeneral
▼ -7.6%on this news
Cingulate’s Shane Schaffer Joins Cast of Nationally Syndicated Big Biz Show
Shane J. Schaffer, CEO of Cingulate Inc., has appeared on the nationally syndicated Big Biz Show to discuss the company's developments, particularly their lead asset CTx-1301 aimed at treating ADHD. He elaborated on Cingulate's commercialization strategies and potential future uses of their Precision Timed Release™ drug delivery platform. The show is accessible globally through multiple broadcasting partners, which may enhance Cingulate's market presence. This event underscores Cingulate's advancements in biopharmaceuticals and therapeutic applications.
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CING Sep 12, 2024CINGPhases
▼ -8.8%on this news· ran to -21% by day 3
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301 $10 Million of additional Capital Recently Raised Strengthening Balance Sheet
Cingulate Inc. has announced the initiation of its final FDA-required food effect study for CTx-1301, a treatment for ADHD. The company has raised over $10 million recently, strengthening its financial position as it prepares for a New Drug Application (NDA) submission in mid-2025. The study aims to understand how food affects the absorption of CTx-1301, with data expected by the end of 2024. Cingulate's proprietary Precision Timed Release (PTR) technology is utilized in CTx-1301, which aims to provide a more effective treatment for ADHD.
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CING Aug 27, 2024CINGConferences/Events
Cingulate to Participate in Benzinga All Live Access Event
Cingulate Inc. (NASDAQ: CING) will have its Chairman and CEO, Shane J. Schaffer, PharmD, participate in the Benzinga All Access event on August 28, 2024. The event will feature a discussion on the company's latest European patent and potential expansions of its Precision Timed Release technology into new therapeutic areas, alongside an overview of the ADHD market. The live stream will be available on Benzinga's YouTube channel and Cingulate's website.
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CING Aug 23, 2024CINGGeneral
▼ -14.6%on this news· ran to -29% by day 3shared move
Cingulate Announces Adjournment of Special Meeting
Cingulate Inc. has adjourned its Special Meeting of Stockholders due to insufficient quorum for voting on proposals. The Board of Directors supports the proposals and encourages stockholders to participate in the adjourned meeting scheduled for August 28, 2024. The company employs a proprietary drug delivery technology aimed at improving treatment outcomes, particularly for ADHD, and is exploring additional therapeutic areas.
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CING Aug 15, 2024CINGGeneral
▲ +160.2%on this news· ran to +859% by day 1
Cingulate Issued European Patent for Lead Asset CTx-1301 for the Treatment of ADHD
Cingulate Inc. has been issued a European patent for its lead asset CTx-1301, intended for the treatment of ADHD. The patent, which includes coverage in multiple European countries, signifies a major milestone for the company as it aims to expand its influence beyond the U.S. ADHD market. Cingulate's proprietary drug delivery platform aims to facilitate better patient outcomes with its multi-core formulation. The company is currently seeking additional patents and preparing for a potential FDA filing.
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CING Aug 13, 2024CINGFDA Updates
▼ -21.1%on this news· ran to +521% by day 3shared move
Cingulate Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025 Licensing Activity
Cingulate Inc. reported its financial results for Q2 2024 and provided updates on its product CTx-1301, which targets ADHD. The FDA has cleared the company to file for marketing approval in the first half of 2025 after major milestones were reached, including the completion of registration batches. Additionally, Cingulate is exploring licensing arrangements and has initiated a payer study to assess potential coverage and reimbursement for CTx-1301. Despite a net loss of $3.2 million in Q2, the company has managed to raise capital through warrant inducement.
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CING Jun 28, 2024CINGGeneral
▼ -45.2%on this news
Cingulate Announces Exercise of Warrants for $1.86 Million Gross Proceeds Kansas City, Kan.
Cingulate Inc. announced the immediate exercise of Series A and B warrants, raising approximately $1.86 million. The proceeds will be allocated towards the continued research and development of its lead product, CTx-1301, along with capital expenditures and general corporate purposes. The move is set to close around July 1, 2024, pending customary closing conditions. Additionally, new Series C and D warrants will be issued in a private placement, enhancing the company's financial resources moving forward.
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CING Jun 25, 2024CINGFDA Updates
Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
Cingulate Inc. has successfully manufactured the required twelve registration batches for its ADHD drug CTx-1301, marking a significant step toward FDA approval. The company is preparing to submit its New Drug Application in the first half of 2025. CTx-1301 utilizes Cingulate's proprietary drug delivery system designed to enhance the effectiveness and duration of ADHD treatment. This achievement aligns with FDA guidelines and supports the company's ongoing development efforts in the ADHD and anxiety treatment sectors.
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CING Jun 25, 2024CINGConferences/Events
Cingulate and ADHD Expert Dr. Ann Childress, MD to Participate in Benzinga All Live Access Event
Cingulate Inc. has announced that its CEO Shane J. Schaffer and psychiatrist Dr. Ann Childress will participate in the Benzinga All Access event on June 26, 2024. The discussion will focus on ADHD and review data from Cingulate's Phase 3 Fixed-Dose Study in pediatric and adolescent populations. The company aims to leverage its Precision Timed Release platform to potentially expand into other therapeutic areas, reflecting ongoing innovation in drug delivery technology. The event will be accessible via Benzinga's YouTube channel and Cingulate's website.
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CING May 8, 2024CINGFDA Updates
Cingulate Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update CTx-1301 on track to file for Marketing Approval with FDA in 1H 2025 Increase of $10 Million in Stockholders' Equity
Cingulate Inc. has reported its financial results for Q1 2024, indicating a commitment to advancing its clinical pipeline, particularly CTx-1301, which is expected to file for FDA marketing approval in the first half of 2025. The biopharmaceutical company raised a total of $10.7 million during the quarter, contributing to a $10 million increase in stockholders' equity. Despite a net loss of $3.0 million, Cingulate's operational strategies, including cost containment, have been implemented to bolster its financial position. The company remains focused on its proprietary Precision Timed Release technology aimed at improving treatment outcomes for conditions like ADHD.
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CING Apr 16, 2024CINGConferences/Events
Cingulate to Participate in Planet MicroCap Showcase: Vegas 2024
Cingulate Inc. will present at the Planet MicroCap Showcase: Vegas 2024 on May 1, 2024, at the Paris Hotel & Casino. The company plans to highlight its Precision Timed Release™ drug delivery technology and its applications in improving treatment for conditions like ADHD. Additionally, Cingulate will conduct individual investor meetings on May 2. A webcast of the presentation will be available on their website afterward.
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CING Apr 1, 2024CINGGeneral
Cingulate Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update $17.8 Million Raised Since Beginning of 2023 $9.1 Million of Debt Converted to Equity at a Premium Phas
Cingulate Inc. released its financial results for the fourth quarter and full year of 2023, reporting substantial capital raised and promising clinical data for its lead asset, CTx-1301, in treating ADHD. The company announced a net loss of $23.5 million for the year, attributed to increased research and development expenditures. Additionally, Cingulate received valuable FDA guidance for its CTx-2103 asset and appointed three new independent board members to strengthen its leadership. Overall, the company is focused on executing its strategic plan and attracting further capital.
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CING Mar 6, 2024CINGConferences/Events
Cingulate to Attend DCAT Week 2024 in New York City
Cingulate Inc. will participate in DCAT Week 2024 from March 18-21 in New York City. The company's Chairman and CEO, Shane J. Schaffer, along with COO Laurie A. Myers, will engage with Global PharmaPartners, INC. to discuss their portfolio including Phase 3 candidate CTx-1301 for ADHD and CTx-2103 for anxiety treatment. The event serves as a strategic platform for Cingulate to explore potential business partnerships.
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CING Feb 13, 2024CINGGeneral
Cingulate Appoints Jay Roberts, Bryan Lawrence, and Jeff Ervin to its Board of Directors Announcement Follows Recent Public Offering and Successful Capital Raising Activity KANSAS CITY, Kan., February 13 2024 - Cingulate
Cingulate Inc. (NASDAQ: CING) has appointed Jay Roberts, Bryan Lawrence, and Jeff Ervin to its Board of Directors. This announcement follows the successful completion of a $7.5 million follow-on public offering and the conversion of outstanding debt into equity. The new board members bring extensive experience in healthcare and finance, which Cingulate anticipates will be pivotal as it advances clinical trials and explores business opportunities, particularly in ADHD treatment and potential expansion into anxiety disorders.
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CING Feb 6, 2024CINGGeneral
Cingulate Announces Closing of $7.5 Million Public Offering
Cingulate Inc. has announced the successful closing of a $7.5 million public offering, which included the issuance of 3,750,000 shares of common stock and accompanying warrants. The funds raised will be utilized for ongoing research and development activities, primarily for the lead candidate CTx-1301, as well as for general corporate purposes. The offering was facilitated by H.C. Wainwright & Co. and was made under a registration statement approved by the SEC. Cingulate aims to enhance treatment options for conditions like ADHD using its Precision Timed Release™ technology.
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CING Feb 2, 2024CINGGeneral
▼ -60.4%on this newsshared move
Cingulate Announces Pricing of $7.5 Million Public Offering
Cingulate Inc. has announced the pricing of its public offering, consisting of 3,750,000 shares at a price of $2.00 per share, expected to close around February 6, 2024. The offering will generate approximately $7.5 million in gross proceeds, which will be allocated towards research and development of its lead candidate CTx-1301, along with working capital and general corporate purposes. The process is being facilitated by Wainwright & Co. and has been registered with the SEC.
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CING Jan 29, 2024CINGGeneral
▼ -11.6%on this news
Werth Family Investment Associates Converts Remaining $3.3M of Debt and Accrued Interest into Cingulate Equity at Premium to Market
Cingulate Inc. announced that Werth Family Investment Associates has converted $3.3 million of debt and accrued interest into equity at a premium conversion price compared to the market. The conversion involves a total amount converting into pre-funded warrants for purchasing shares of Cingulate's common stock. This decision reflects confidence in Cingulate's business and its proprietary Precision Timed Release drug delivery platform, which aims to deliver innovative treatments for ADHD and other conditions. This move positions Cingulate favorably for future product development and market expansion.
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CING Dec 1, 2023CINGFDA Updates
Cingulate Receives Guidance from FDA on Path Forward for Anxiety Asset CTx-2103 (buspirone)
Cingulate Inc. has announced that it received guidance from the FDA regarding the regulatory pathway for its investigational anxiety treatment, CTx-2103 (buspirone). This pathway includes filing an IND application in the first half of 2024, which could potentially lead to a faster approval process under the 505(b)(2) route. CTx-2103 aims to offer a once-daily multi-dose tablet that may improve treatment compliance compared to existing anxiety medications. The drug is positioned as a distinct option in treating anxiety disorders, addressing a significant unmet medical need.
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CING Nov 13, 2023CINGPhases
Cingulate Inc. Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update Phase 3 Adult Efficacy and Safety Trial Data Presented at Psych Congress Cingulate Closed a $4M Public Offering $5.8M
Cingulate Inc. reported its financial results for Q3 2023 and provided updates on its clinical programs, including the Phase 3 trial for CTx-1301 in adults with ADHD. Although the trial showed promising trends, it did not achieve statistical significance on the primary endpoint. The company secured $4 million from a recent public offering and converted $5.8 million in debt into equity. Cingulate continues to advance its ADHD pipeline despite experiencing a net loss of $6 million during the quarter.
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CING Oct 17, 2023CINGConferences/Events
Cingulate to Host CNS Key Opinion Leader Panel in New York City Expert Analysis of Cingulate, it's Phase 3 ADHD Adult Data, Anxiety, and PTR Drug Delivery Platform Innovations
Cingulate Inc. will host a key opinion leader panel in New York City on October 23, 2023, to discuss its Phase 3 adult data for ADHD and anxiety. The event, moderated by key medical figures, aims to deepen understanding of Cingulate's drugs and their delivery platforms. This panel represents a significant opportunity for stakeholders in healthcare and the pharmaceutical industry to engage with the latest findings and innovations by Cingulate.
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CING Sep 21, 2023CINGConferences/Events
Cingulate Inc. to Present at the LD Micro Main Event XVI
Cingulate Inc. will be presenting at the LD Micro Main Event XVI on October 4, 2023, in Los Angeles. The event will showcase around 200 companies and offer opportunities for private meetings with investors. CEO Shane J. Schaffer will provide an overview of the company, which focuses on developing next-generation pharmaceutical products using its proprietary drug delivery platform. The LD Micro conference aims to connect small-cap companies with potential investors and emphasize industry trends.
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CING Sep 13, 2023CINGGeneral
Cingulate Announces Closing of $4.0 Million Public Offering
Cingulate Inc. has completed a public offering, raising approximately $4.0 million through the sale of 6,925,208 shares of common stock and associated warrants. The proceeds from this offering will be utilized to advance the research, development, and commercialization of its lead drug candidate, CTx-1301. The public offering was facilitated by H.C. Wainwright & Co. and was made pursuant to an SEC registration statement effective as of September 11, 2023.
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CING Sep 11, 2023CINGPhases
Cingulate Announces Detailed Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD
Cingulate Inc. revealed results from a Phase 3 trial for CTx-1301, demonstrating positive trends in ADHD symptom improvement compared to placebo, though the study did not achieve statistical significance on the primary endpoint. The drug exhibited a favorable safety profile and significant improvements in associated scales, particularly the Permanent Product Measure of Performance and Clinical Global Impression Scale. The treatment effect size was notably high at both 30 minutes and over 16 hours. This investigational compound aims to deliver comprehensive, once-daily coverage for ADHD medication.
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CING Sep 11, 2023CINGGeneral
Cingulate Announces Pricing of $4.0 Million Public Offering
Cingulate Inc. has announced the pricing of a public offering of approximately $4.0 million, involving nearly 6.9 million shares of common stock and warrants. The proceeds from the offering are intended for the ongoing research and development of its lead candidate, CTx-1301, and for other general corporate purposes. The offering is set to close around September 13, 2023, pending the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering.
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CING Sep 8, 2023CINGGeneral
Werth Family Investment Associates Converts $5.8 Million of Debt into Cingulate Equity at a Premium Conversion Follows $1.0 Million Capital Investment in August 2023
Cingulate Inc. announced the successful conversion of $5.8 million of debt into equity by Werth Family Investment Associates, following a previous investment of $1 million. The debt conversion was executed at a premium conversion price of $0.85 per share, above the current stock price. This financial maneuver signals investor confidence, but also highlights that $3 million of the original note remains outstanding. Cingulate continues to leverage its proprietary drug delivery platform and is positioned to expand its pipeline of pharmaceutical products, particularly in ADHD treatments.
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CING Sep 5, 2023CINGPhases
Cingulate Announces Presentation of Full Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD at Psych Congress 2023
Cingulate Inc. announced the full results of the Phase 3 adult efficacy and safety trial of CTx-1301 for ADHD at the upcoming Psych Congress 2023. This investigational treatment is designed as a once-daily stimulant, showcasing a potential for a rapid onset of action and long-lasting effectiveness throughout the day. The data not only highlights CTx-1301's efficacy but also its tolerability. Cingulate plans to submit a New Drug Application for CTx-1301 in the latter half of 2024, pending favorable clinical outcomes from ongoing trials.
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CING Aug 14, 2023CINGPhases
Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update Werth Family Investment Associates Provides Additional Capital Investment Phase 3 Adult Efficacy and Safety Trial of
Cingulate Inc. has reported its second quarter 2023 financial results alongside an update on its clinical and business activities. Notable achievements include the successful completion of a Phase 3 Adult Efficacy and Safety Trial for CTx-1301 and a $1 million investment from Werth Family Investment Associates. The company is now initiating Phase 3 studies for pediatric and adolescent populations and plans to submit a New Drug Application for CTx-1301 by the end of 2024. However, the adult trial did not meet statistical significance for its primary endpoint, and the company has experienced an increase in net losses due to rising development costs.
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CING Jul 11, 2023CINGPhases
Cingulate Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD Results Indicative that CTx-1301 Provides Entire Active-Day Efficacy with Optimal Onset
Cingulate Inc. announced positive results from its Phase 3 trial of CTx-1301, a once-daily medication for ADHD. The study demonstrated meaningful improvements in ADHD symptoms and a favorable safety profile compared to placebo. The company plans to submit a New Drug Application for CTx-1301 by mid-2024 while also preparing for additional trials in pediatric patients. These results suggest CTx-1301 could address significant unmet needs in ADHD treatment.
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CING Jun 29, 2023CINGPhases
Cingulate Successfully Manufactures Clinical Supply - Initiation of Pediatric Phase 3 Studies to Commence in July and August Announcement Confirms Cingulate on Track with Development and Regulatory Milestones
Cingulate Inc. has successfully manufactured clinical supply for its pivotal Phase 3 trials of CTx-1301 for ADHD, with trials set to begin in late July. The achievement confirms that the company remains on schedule with its development timeline. CTx-1301 is positioned as a once-daily stimulant medication aimed at improving ADHD treatment. Positive results from these upcoming studies could lead to a New Drug Application submission in mid-2024.
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CING Jun 14, 2023CINGConferences/Events
Cingulate to Participate in the Healthcare Virtual Conference Part II Presented by Maxim Group and Hosted by M-Vest
Cingulate Inc. has announced that its Chairman and CEO, Shane J. Schaffer, will participate in the Healthcare Virtual Conference Part II, hosted by Maxim Group and M-Vest. This three-day event will take place from June 20th to June 22nd, with Dr. Schaffer discussing the company on June 22nd at 10:30 AM EST. Cingulate is focused on advancing its proprietary drug delivery technology aimed at treating neurological disorders and other therapeutic areas.
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CING Jun 8, 2023CINGPhases
Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD Study Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023 Pivotal Phase 3 Trials in Pediatric/Adolescent Patients
Cingulate Inc. has completed its Phase 3 adult dose-optimization trial for CTx-1301, an investigational treatment for ADHD. The trial assessed the onset and duration of the medication in adults and results are anticipated in the third quarter of 2023. Following the success of this trial, Cingulate plans to initiate pivotal Phase 3 studies for pediatric and adolescent populations in the same time frame. The potential success of CTx-1301 could lead to a New Drug Application submission in mid-2024, enhancing treatment options for ADHD patients.
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CING May 25, 2023CINGConferences/Events
Cingulate to Present at 13th Annual LD Micro Invitational
Cingulate Inc. (NASDAQ: CING) announced its participation in the 13th Annual LD Micro Invitational taking place from June 6th-8th, 2023, in Los Angeles. The company's CEO, Shane J. Schaffer, will present an overview on June 6th at 9:30 a.m. PST. Cingulate is advancing its lead candidate, CTx-1301, a once-daily treatment for ADHD, while also exploring additional applications of its Precision Timed Release technology for other conditions, such as anxiety.
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CING May 12, 2023CINGConferences/Events
Cingulate, Indegene to Participate in Benzinga All Live Access Event
Cingulate Inc. announced that its Chairman & CEO, Shane J. Schaffer, and Indegene's Senior Vice President, Timothy Moore, will participate in a live Benzinga All Access event on May 15, 2023. The discussion will address a new joint commercialization agreement aimed at supporting Cingulate's lead candidate, CTx-1301, for ADHD treatment. This collaboration highlights Cingulate’s commitment to improving patient treatment through its Precision Timed Release technology.
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CING May 10, 2023CINGGeneral
Cingulate Inc. Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update Additional $3 Million of Financing Proprietary PTR Manufacturing Processes Successfully Transferred to Societal CDMO J
Cingulate Inc. announced its financial results for the first quarter of 2023 alongside a clinical and business update. The company secured an additional $3 million in financing and successfully transferred its proprietary manufacturing processes to Societal CDMO. A joint commercialization agreement was established with Indegene to support the development of CTx-1301, an investigational ADHD treatment. Cingulate is on track with its Phase 3 trials and is evaluating multiple strategies for future capital needs.
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CING May 3, 2023CINGPhases
Cingulate Announces Successful Transfer of CTx-1301 (dexmethylphenidate) Proprietary PTR Manufacturing Processes to Societal CDMO Scalable Supply of CTx-1301 Ready to be Produced with Cingulate on Track to Meet Previousl
Cingulate Inc. has successfully transferred its CTx-1301 manufacturing processes to Societal CDMO, marking a significant step in the progress of its ADHD treatment candidate. The company is on track with its clinical timelines for ongoing Phase 3 trials, which evaluate the effectiveness of its proprietary Precision Timed Release technology. CTx-1301 aims to provide precise dosing throughout the day, improving on existing stimulant therapies. The next key steps include producing the necessary tablet supply for trials and planning to submit a New Drug Application in mid-2024.
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CING Apr 4, 2023CINGPhases
Cingulate Completes First Cohort of Phase 3 Adult Onset and Duration Trial of CTx-1301 (dexmethylphenidate) for ADHD
Cingulate Inc. has completed the first cohort of its Phase 3 trial for CTx-1301, a treatment for ADHD. This pivotal study, involving up to 25 adult participants, evaluates the drug's onset and duration of effects. Results are anticipated in the third quarter of 2023. Cingulate aims to provide an effective once-daily treatment option, addressing a significant market need in the ADHD therapeutics landscape. The company also plans to initiate a Phase 3 trial for pediatric and adolescent patients by mid-2023.
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CING Mar 13, 2023CINGGeneral
Cingulate and Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301
Cingulate Inc. has entered a joint commercialization agreement with Indegene to support the launch of its lead ADHD candidate, CTx-1301, upon FDA approval. This agreement aims to provide comprehensive commercial support, leveraging Indegene's omnichannel marketing approach during Cingulate's Phase 3 clinical trials. CTx-1301 is designed to be a once-daily stimulant medication that will address unmet needs in the ADHD market by offering an entire active-day efficacy. The partnership is expected to streamline Cingulate's focus on clinical development while optimizing commercial efforts.
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CING Mar 10, 2023CINGPhases
Cingulate Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical and Business Update CTx-1301 Phase 3 Adult Dose-Optimization Study Ongoing; Results Expected 3Q 2023 Positive Top-Line Data
Cingulate Inc. reported its financial results for Q4 and full year 2022, highlighting ongoing clinical studies for CTx-1301, an ADHD treatment. The Phase 3 adult dose-optimization study is currently underway, with results anticipated in Q3 2023. The company also plans to begin a pivotal Phase 3 trial for pediatric patients in mid-2023. Despite reporting a net loss increase, Cingulate remains optimistic about its product development pipeline, aiming for an NDA submission for CTx-1301 in early 2024.
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CING Feb 23, 2023CINGPhases
Cingulate Announces Positive Top-Line Results from Fed/Fast Study of Lead Asset CTx-1301 for ADHD
Cingulate Inc. announced positive top-line results from its CTx-1301 study, demonstrating that the ADHD treatment can be effectively taken with or without food. This investigational drug aims to offer a once-daily solution for ADHD, enhancing patient compliance. The company has commenced its Phase 3 trials, including an adult study focused on efficacy and safety, with results anticipated in the third quarter of 2023. These developments mark a significant advancement for Cingulate's novel formulation in ADHD treatment.
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CING Jan 4, 2023CINGPhases
Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD
Cingulate Inc. has announced the initiation of a Phase 3 clinical trial for its lead candidate, CTx-1301, which is designed to offer a comprehensive treatment for adults with ADHD. This investigational drug utilizes a proprietary Precision Timed Release (PTR) technology to deliver an extended release of dexmethylphenidate. The trial aims to study the efficacy and safety of CTx-1301 compared to a placebo, with results anticipated in the first half of 2023. This innovative approach seeks to eliminate the need for booster pills and aims to provide sustained effectiveness throughout the day.
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CING Dec 1, 2022CINGGeneral
Cingulate Benzinga All Live Access Appearance Rescheduled for December 16
KANSAS CITY, Kan., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products,
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CING Nov 14, 2022CINGPhases
Cingulate Inc. Reports Third Quarter 2022 Financial Results and Provides Clinical and Business Update Phase 3 Trial Initiation for Lead ADHD Candidate CTx-1301 in December 2022 Executed Manufacturing Agreement with Socie
Inc. Reports Third Quarter 2022 Financial Results and Provides Clinical and Business Update
3 Trial Initiation for Lead ADHD Candidate CTx-1301 in December 2022
Manufacturing Agreement with Societal CDMO
Psych Congress Presentation Demonstrated Ability of Anxiety Candidate CTx
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CING Nov 1, 2022CINGGeneral
Cingulate Completes Fed/Fast Study Assessing Food Effect with CTx-1301, Lead Candidate for Treatment of ADHD
KANSAS CITY, Kan., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products,
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CING Oct 24, 2022CINGGeneral
Cingulate Announces Agreement with Societal CDMO and Provides Clinical Update New Partnership will Improve and Advance CING Manufacturing Operations
Announces Agreement with Societal CDMO and Provides Clinical Update
Partnership will Improve and Advance CING Manufacturing Operations
CITY, Kan., October 24, 2022 - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed
Release (P
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CING Oct 20, 2022CINGConferences/Events
Cingulate to Present at LD Micro Investor Conference
KANSAS CITY, Kan., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products,
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CING Sep 19, 2022CINGConferences/Events
Cingulate Presents Data for Its Triple-Release Buspirone Product Candidate: CTx-2103
Data Demonstrated Ability of CTx-2103 to Deliver a Single Administration of Triple-Release Buspirone – Setting the Stage for Future Trials Employing Cingulate’s Precision Timed Release™ (PTR™) Technology
CTx-2103 has the Potential to be the First Once-Daily Formulation of Buspir
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CING Aug 11, 2022CINGGeneral
Cingulate Inc. Reports Second Quarter 2022 Financial Results and Provides Clinical and Business Update $5 Million of Non-Dilutive Financing Veteran Biotech Executive Appointed to Board
Inc. Reports Second Quarter 2022 Financial Results
Provides Clinical and Business Update
Million of Non-Dilutive Financing
Biotech Executive Appointed to Board
CITY, Kan., August 11, 2022 - Cingulate Inc. (NASDAQ: CING), a clinical-stage
biopharmaceutical company utilizing i
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CING Jun 23, 2022CINGGeneral
Cingulate Announces Completion of CTx-2103 Human Formulation Study for the Treatment of Anxiety Disorders
KANSAS CITY, Kan., June 23, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceut
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CING Jun 17, 2022CINGConferences/Events
Cingulate to Present at Diamond Equity Research 2022 Virtual Emerging Growth Invitational
KANSAS CITY, Kan., June 17, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceut
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CING May 24, 2022CINGPhases
Cingulate Announces Complete Enrollment in Human Formulation Study of CTx-2103 for the Treatment of Anxiety Disorders
Active Pharmaceutical Ingredient – Buspirone – One of the Most Widely Prescribed Agents in $5.5B U.S. Anxiety Market, Which Must be Taken Multiple Times Daily
CTx-2103 is the Third Candidate Using Cingulate’s Proprietary Precision Timed Release™ Drug Delivery Platform Technology
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CING May 18, 2022CINGConferences/Events
Cingulate to Present at H.C. Wainwright Global Investment Conference
KANSAS CITY, Kan., May 18, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceuti
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CING May 12, 2022CINGPhases
Cingulate Inc. Reports First Quarter 2022 Results and Provides Clinical and Business Update Announcement of First Subject Dosing for Anxiety Candidate CTx-2103 to Extend the Application of the Precision Timed Release Pla
Inc. Reports First Quarter 2022 Results
Provides Clinical and Business Update
of First Subject Dosing for Anxiety Candidate CTx-2103 to Extend the Application of the Precision Timed Release Platform
CITY, Kan., May 12, 2022 - Cingulate Inc. (NASDAQ: CING), a clinical-stage
bi
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CING Apr 26, 2022CINGConferences/Events
Cingulate Presents at NobleCon18
KANSAS CITY, Kan., April 26, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceu
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CING Mar 10, 2022CINGGeneral
Cingulate Inc. Reports Fourth Quarter and Full Year 2021 Results and Provides Clinical and Business Update Completed Initial Public Offering, Raising Gross Proceeds of $25.0 Million Expedited Clinical Program for CTx-130
Inc. Reports Fourth Quarter and Full Year 2021 Results
Provides Clinical and Business Update
Initial Public Offering, Raising Gross Proceeds of $25.0 Million
Clinical Program for CTx-1301 Expected to Reduce Capital Requirements and Time to Approval
CITY, Kan., March 10, 2022
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CING Feb 15, 2022CINGConferences/Events
Cingulate to Present at Aegis Virtual Conference
KANSAS CITY, Kan., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceut
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CING Feb 8, 2022CINGGeneral
Cingulate Provides 2022 Clinical Plan for CTx-1301, an Investigational Medication for Attention Deficit/Hyperactivity Disorder (ADHD) Expedited Clinical Program Reduces Capital Requirements
Provides 2022 Clinical Plan for CTx-1301, an Investigational
Medication for Attention Deficit/Hyperactivity Disorder (ADHD)
Clinical Program Reduces Capital Requirements
CITY, KS, February 8, 2022 - Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company util
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CING Jan 25, 2022CINGGeneral
Cingulate Appoints Curt Medeiros and Gregg Givens to Board of Directors
KANSAS CITY, Kan., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Following its initial public offering last month, Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build an
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CING Dec 10, 2021CINGGeneral
▼ -5.4%on this news· ran to -23% by day 3
Cingulate Inc. Announces Closing of Initial Public Offering
KANSAS CITY, Kan., Dec. 10, 2021 (GLOBE NEWSWIRE) -- Cingulate Inc. (“Cingulate” or the “Company”), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-gener
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CING Dec 8, 2021CINGGeneral
Cingulate Inc. Announces Pricing of $25.0 Million Initial Public Offering
KANSAS CITY, Kan., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Cingulate Inc. (“Cingulate” or the “Company”), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-gener
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