Core Viewpoint - Cingulate Inc. successfully closed a $12 million PIPE financing, indicating strong validation of its strategy and technology in the ADHD treatment market [1][2]. Financing Details - The PIPE financing was led by Falcon Creek Capital and completed at a price of $5.04 per share, with 80% warrant coverage [2][9]. - All investors in the PIPE financing are subject to a 180-day lock-up period, aligning long-term interests [3][9]. - The financing proceeds will support general operations and the commercial launch of CTx-1301, pending FDA approval [4][9]. Product Information - CTx-1301 is a once-daily, multi-core tablet designed to provide consistent symptom control for ADHD, utilizing Cingulate's Precision Timed Release™ platform [8][11]. - The FDA accepted Cingulate's NDA for CTx-1301 in October 2025, with a PDUFA target action date set for May 31, 2026 [9]. Company Overview - Cingulate Inc. focuses on developing next-generation pharmaceutical products for ADHD and other CNS disorders, leveraging its proprietary technology [11]. - The company is headquartered in Kansas City, Kansas, and aims to improve therapeutic outcomes for conditions with suboptimal treatment coverage [11]. Investor Relations - Falcon Creek Capital, a specialized investment firm, will designate up to two members to Cingulate's board, enhancing governance and strategic execution [4][12].

Group 1 - Biotech stocks experienced significant gains in after-hours trading, with several companies showing strong percentage increases despite no new company-specific news [1][2][3][4] - Coherus Oncology, Inc. (CHRS) rose by 9.09% to close at $1.73, adding $0.14 in extended trading [1] - Sensei Biotherapeutics, Inc. (SNSE) surged 10.06% to finish at $12.47, gaining $1.14 [1] - Cue Biopharma, Inc. (CUE) advanced 9.37% to $0.40, increasing by $0.034 [1] - Alpha Tau Medical Ltd. (DRTS) increased by 3.35% to $7.41, up $0.24, with recent focus on new leadership [2] - Cingulate Inc. (CING) edged up 1.49% to close at $5.45, gaining $0.08 [3] - uniQure N.V. (QURE) posted a notable 9.96% jump to $24.95, adding $2.26 in after-hours trading [3] - IO Biotech, Inc. (IOBT) gained 4.19% to $0.50, up $0.020, while exploring strategic alternatives including mergers and asset sales [4]

Core Insights - Cingulate Inc. has made significant progress with the acceptance of its New Drug Application (NDA) for CTx-1301 by the FDA, with a target action date set for May 31, 2026 [2][20] - The company appointed Bryan Downey as Chief Commercial Officer, bringing over 25 years of experience in the pharmaceutical industry [3][6] - A $6 million financing transaction was completed to strengthen the company's balance sheet ahead of potential commercialization [3][4] Recent Highlights - The FDA accepted the NDA for CTx-1301, a once-daily extended-release therapy for ADHD, confirming the submission is complete and ready for review [2][20] - Positive Phase 3 trial results for CTx-1301 were presented at the AACAP Annual Meeting, showing significant improvements in ADHD symptoms [5][6] Financial Overview - As of September 30, 2025, Cingulate reported approximately $6.1 million in cash and cash equivalents, a decrease from $12.2 million at the end of 2024 [10][15] - The company incurred a net loss of $7.3 million for the third quarter of 2025, compared to a loss of $4.1 million in the same period of 2024, primarily due to increased R&D and G&A expenses [13][11] Operational Developments - A commercial supply agreement was established with Bend Bio Sciences for the manufacturing of CTx-1301, ensuring exclusive supply through 2028 if FDA approved [7] - Cingulate received a PDUFA fee waiver from the FDA, saving approximately $4.3 million [8][9] Research and Development - R&D expenses for the third quarter of 2025 were $2.8 million, a 99.5% increase from the previous year, driven by higher personnel and manufacturing costs [11] - General and administrative expenses rose to $3.1 million, a 69.7% increase from the same quarter in 2024, largely due to personnel costs related to the NDA submission [12]

Core Insights - Cingulate Inc. has appointed Bryan Downey as Chief Commercial Officer to advance the commercialization of CTx-1301, following FDA acceptance of its New Drug Application (NDA) with a target action date of May 31, 2026 [1][12] - The company has completed a $6 million financing transaction to strengthen its cash position and extend its cash runway into the second quarter of 2026, supporting its commercialization efforts pending FDA approval [2][8] Company Developments - Bryan Downey brings over 25 years of experience in commercial strategy and product launches, having held senior roles at Alfasigma USA, Jubilant Pharma, and Sanofi [3][4] - Cingulate's CTx-1301 is designed to provide rapid onset and all-day ADHD symptom control with a single daily dose, differentiating it from existing medications that often require multiple doses [5][12] - The company has partnered with Indegene to establish the commercial infrastructure and market access strategies necessary for the successful launch of CTx-1301 [5] Financial Overview - The $6 million financing was structured as a non-convertible, unsecured promissory note with a 9% annual interest rate, maturing in 18 months, allowing for monthly redemptions post-PDUFA date [8] - The proceeds from the financing will be utilized for working capital and general corporate purposes [8] Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, enabling three timed releases of medication from a single tablet to maintain focus throughout the day [5][12] - The global ADHD market is valued at over $23 billion annually, indicating significant market potential for Cingulate's innovative product [5]

Core Insights - Cingulate Inc. announced positive Phase 3 results for CTx-1301, a once-daily formulation of dexmethylphenidate for pediatric ADHD, achieving primary endpoints with significant symptom relief [1][3] - The ADHD market is valued at $23 billion, with CTx-1301 offering a potential advantage through its once-daily dosing, which may improve patient adherence [3] Group 1: Clinical Trial Results - CTx-1301 demonstrated dose-dependent improvements on ADHD ratings scale and Clinical Global Impression-Severity scales, providing symptom relief for up to 12 hours post-dose [1] - The randomized, double-blind, placebo-controlled study showed rapid onset of effect and sustained efficacy, with a safety profile consistent with other stimulant medications [2] Group 2: Product and Market Potential - The 37.5mg dose of CTx-1301 showed the largest effect size in symptom reduction, indicating substantial efficacy [3] - Cingulate's partnership with Indegene is structured to align commercial execution with growth milestones as the company approaches product launch [3] Group 3: Regulatory and Financial Aspects - The New Drug Application for CTx-1301 was accepted by the FDA, with a target PDUFA date of May 31, 2026, and a waiver of the standard PDUFA filing fee saving the company approximately $4.3 million [4] - Cingulate plans to share additional details from the Phase 3 study in future scientific publications and investor communications [6] Group 4: Company Overview - Cingulate Inc. utilizes its Precision Timed Release™ platform to develop next-generation pharmaceutical products aimed at improving patient outcomes in conditions requiring complex dosing [9] - CTx-1301 is in late-stage development for ADHD, with additional candidates targeting anxiety and other neuropsychiatric conditions [9]

Core Insights - Biotech stocks experienced significant gains in after-hours trading, with Inhibrx Biosciences leading the surge due to positive trial results [1][2] Company Summaries - **Inhibrx Biosciences (INBX)**: Shares surged over 81% to $51.52 following positive topline results from the ChonDRAgon study, which evaluated ozekibart as a monotherapy for advanced chondrosarcoma. The company also reported progress on expansion cohorts for colorectal cancer and Ewing sarcoma [2] - **Femasys Inc. (FEMY)**: Stock increased by more than 18% to $0.7227 after launching a post-market surveillance clinical study for its FemBloc Permanent Birth Control, complying with EU Medical Device Regulation [3] - **Cingulate Inc. (CING)**: Shares rose over 6% to $3.80 after announcing that data from its ADHD candidate CTx-1301 was selected for presentation at the AACAP Annual Meeting, highlighting its potential in ADHD treatment [4] - **Community Health Systems, Inc. (CYH)**: Stock increased over 4% to $3.41 following positive Q3 results [5] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares climbed over 10% to $0.6295 in after-hours trading [6] - **Ascendis Pharma A/S (ASND)**: Stock gained more than 4%, reaching $210.68 post-market [6] - **ADC Therapeutics SA (ADCT)**: Shares rose over 5% to $4.2887 in after-hours trading [6] - **Zura Bio Limited (ZURA)**: Stock increased more than 5% to $3.55 post-market [6] - **Foghorn Therapeutics Inc. (FHTX)**: Shares gained more than 5%, closing at $4.11 after hours [6]

Core Insights - Cingulate Inc. announced that data from its lead ADHD candidate CTx-1301 has been selected for podium presentation at the AACAP Annual Meeting, indicating significant scientific interest in the product [1][2][3] - CTx-1301 is designed as a once-daily, extended-release formulation aimed at improving treatment for ADHD by addressing limitations of current stimulant therapies [3][5] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) platform [1][6] - The company is headquartered in Kansas City, Kansas, and is advancing a pipeline that includes candidates for ADHD and other neuropsychiatric conditions [6] Product Details - CTx-1301 (dexmethylphenidate HCl) utilizes the PTR™ platform to provide three precisely timed releases of medication throughout the day, aiming for rapid onset and full-day symptom control [5] - The product is currently being evaluated under the FDA's 505(b)(2) pathway for ADHD treatment [5] ADHD Context - ADHD affects an estimated 20 million individuals in the U.S., including around 8 million children and 12 million adults, characterized by inattention, hyperactivity, and impulsivity [4] - Current stimulant medications, while the gold standard, often require multiple daily doses and may not provide consistent coverage throughout the day [4]

Core Insights - Cingulate Inc. announced that the FDA has accepted the New Drug Application (NDA) for CTx-1301, a treatment for ADHD, with a target action date of May 31, 2026 [1][3] - The NDA is being reviewed under the FDA's 505(b)(2) pathway, allowing Cingulate to leverage existing data on dexmethylphenidate while demonstrating novel clinical benefits [2][10] - CTx-1301 has shown significant improvements in ADHD symptoms during Phase 3 trials, indicating its potential to address gaps in current ADHD management [4][6] Regulatory Milestone - The acceptance of the NDA marks a significant regulatory milestone for Cingulate and the CTx-1301 program, validating the completeness of their submission [3][5] - The FDA's review will assess the efficacy, safety, and overall risk-benefit profile of CTx-1301 [7] Clinical Results - Phase 3 trials demonstrated that CTx-1301 provides rapid onset of effect and sustained efficacy throughout the day, addressing issues with current stimulant therapies [4][6] - No serious treatment-emergent adverse events were reported, indicating a favorable safety profile [6] Commercial Strategy - Cingulate is preparing for a timely launch of CTx-1301, having completed process transfer and scale-up production with its manufacturing partner [7] - The company is leveraging an AI-driven omnichannel platform to optimize prescriber reach and patient support, with early research indicating strong formulary receptivity for CTx-1301 [8] Market Context - ADHD affects approximately 20 million individuals in the U.S., with stimulant medications being the gold standard for treatment [9] - Current extended-release formulations often require multiple doses, highlighting the need for a once-daily solution like CTx-1301 [9][10]

Core Insights - Cingulate Inc. has entered into a strategic commercial supply agreement with Bend Bio Sciences for the manufacturing of its lead asset CTx-1301, pending FDA approval [1][3] - CTx-1301 is a novel, extended-release formulation of dexmethylphenidate aimed at addressing limitations of current ADHD therapies, with an NDA submitted to the FDA on July 31, 2025 [2][3] - The agreement ensures Bend Bio Sciences will be the exclusive manufacturer of CTx-1301 in the U.S. through 2028, contingent on FDA approval, providing manufacturing security and operational efficiency for Cingulate [3][4] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][9] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9] Product Details - CTx-1301 utilizes Cingulate's PTR technology to deliver dexmethylphenidate in a multi-core formulation designed for precise release at defined intervals, addressing the challenge of providing an entire active-day duration of action [6][7] - The formulation is designed to enhance patient care by delivering medication in a single tablet, improving adherence and treatment efficacy [6][8] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment options are often inadequate, highlighting the need for innovative therapies like CTx-1301 [5][6] - The prevalence of adult ADHD is growing faster than that of children and adolescents, indicating a substantial market opportunity for effective treatment solutions [5]

Core Viewpoint - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for its lead asset CTx-1301, an innovative ADHD treatment, with an anticipated FDA decision in Q4 2025 and a potential PDUFA date in mid-2026 [1][2][4]. Recent Highlights - The NDA submission for CTx-1301, a novel extended-release tablet formulation of dexmethylphenidate, aims to address limitations of current ADHD therapies by providing fast onset and entire active-day efficacy [2][4]. - Cingulate entered into a purchase agreement with Lincoln Park Capital to purchase up to $25 million of common stock over a 36-month term, allowing the company to manage its capital needs effectively [3][4]. Financial Results - As of June 30, 2025, Cingulate reported approximately $8.9 million in cash and cash equivalents, a decrease of $3.3 million from December 31, 2024, and expects to need an additional $1.5 million to support commercialization efforts for CTx-1301 [5]. - Research and development expenses increased by 43.6% to $2.7 million for the three months ended June 30, 2025, primarily due to costs associated with the NDA submission [6]. - General and administrative expenses rose by 47.1% to $1.9 million for the same period, mainly due to higher legal and financial advisory fees [7]. - The net loss for the three months ended June 30, 2025, was $4.8 million, compared to $3.2 million for the same period in 2024, reflecting increased R&D costs [7]. Product and Technology Overview - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to deliver dexmethylphenidate in a way that optimizes patient care with a single tablet providing multiple releases throughout the day [15][17]. - The PTR technology incorporates an Erosion Barrier Layer (EBL) that controls drug release at precise times, aiming to improve treatment outcomes for ADHD and potentially other therapeutic areas [17][18]. Market Context - ADHD affects millions, with over 20 million diagnosed in the U.S., including 12 million adults and over 8 million children under 17, indicating a significant market opportunity for effective treatments [14].