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 - Cingulate Inc. announced that data from its lead ADHD candidate CTx-1301 has been selected for podium presentation at the AACAP Annual Meeting, indicating growing scientific interest in the product [1][3] - CTx-1301 is a once-daily, extended-release formulation designed to simplify ADHD treatment for millions [1][4] 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, anxiety, and other neuropsychiatric conditions [6] Product Details - CTx-1301 (dexmethylphenidate HCl) utilizes the PTR™ platform to deliver three precisely timed releases of medication throughout the day, aiming for rapid onset and full-day efficacy [5] - The product is currently being evaluated under the FDA's 505(b)(2) pathway for ADHD treatment [5] Clinical Presentation - The Phase 3 data for CTx-1301 will be presented by Dr. Ann Childress, a leading ADHD specialist, at the AACAP Annual Meeting [2][3] - The presentation will focus on the efficacy and safety of CTx-1301 in pediatric subjects with ADHD [2] ADHD Context - ADHD affects an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults, characterized by inattention, hyperactivity, and impulsivity [4] - Current stimulant medications often require multiple daily doses and may not provide consistent coverage throughout the day [4]

Group 1: Government Actions and Claims - The US administration, led by President Trump, aims to address rising autism diagnoses by targeting the OTC painkiller Tylenol, linking its use by pregnant women to increased autism risk [1][4][5] - The administration plans to change safety labels for acetaminophen and launch a public service campaign to inform families about the potential risks [5][6] Group 2: Scientific Evidence and Expert Opinions - The administration cited large-scale studies suggesting a link between in-utero acetaminophen exposure and autism, but experts have called for more research and caution in interpreting these findings [6][7] - Major health organizations, including the WHO and various national health bodies, have refuted the claims, stating there is no conclusive evidence linking Tylenol to autism [8][9] Group 3: Legal Context and Market Implications - Previous lawsuits against Tylenol's marketer, Kenvue, claiming links to autism were dismissed in 2023 due to inadequate scientific evidence, but appeals are planned [11][12] - In India, paracetamol remains a widely used OTC drug, with significant sales figures, but concerns over its dosage persist, leading to regulatory actions against certain combinations [12]

Core Insights - Supernus Pharmaceuticals is launching a new video series featuring Jay Glazer and his wife Rosie, focusing on the impact of ADHD on relationships and the role of Qelbree in managing ADHD symptoms [1][2][3] - The series aims to foster open discussions about ADHD, sharing practical strategies for symptom management and insights from both Jay and Rosie [2][3] Company Overview - Supernus Pharmaceuticals is a biopharmaceutical company dedicated to developing and commercializing treatments for central nervous system (CNS) diseases, including ADHD [11][12] - The company has a diverse neuroscience portfolio that includes approved treatments for various CNS disorders, and is actively developing new potential treatments for conditions such as epilepsy and depression [12] Product Information - Qelbree (viloxazine extended-release capsules) is a non-stimulant prescription medication used to treat ADHD in individuals aged 6 years and older [5][10] - Qelbree is available in three dosages: 100 mg, 150 mg, and 200 mg capsules [10]

Company Overview - Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases [15] - The company has a diverse neuroscience portfolio that includes approved treatments for ADHD, dyskinesia in Parkinson's disease, epilepsy, migraine, and other CNS disorders [16] Product Information - Qelbree (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children aged 6 years and older [6] - Qelbree is a novel, once-a-day, non-stimulant approach for ADHD treatment and is the first non-stimulant approved for adults with ADHD in 20 years [4] - As a non-stimulant, Qelbree has no evidence of abuse or misuse and can be conveniently refilled without needing a new prescription each month [4] Campaign and Awareness - The 'Ms. Represented' campaign, in partnership with Busy Philipps, aims to empower women with ADHD to understand their symptoms and seek help [1][4] - The campaign highlights the often-misrepresented experiences of women with ADHD, focusing on the differences in symptom presentation between genders [2][3] - Increased awareness of ADHD symptoms among females is leading to more women seeking diagnosis and treatment [3] Market Insights - Studies indicate that boys are twice as likely as girls to be diagnosed with ADHD, resulting in many women remaining undiagnosed or misdiagnosed until adulthood [3] - The campaign seeks to address the disparity in ADHD diagnosis and treatment between males and females [4]