Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 371

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 371
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 -impulsivity, and affects cognitive, academic, behavioral, emotional, and social functioning. An estimated 8.4% of children and 5% of adults in the United States have a current diagnosis of ADHD, and if left untreated can lead to poor occupational and psychosocial outcomes. According to a report published by Global Market Insights on December 17, 2024, the global ADHD market was valued at $15.8 billion in 2023 and is projected to grow at a CAGR of over 5.1 %from 2024 to 2032. Furthermore, based on a report by Grand View Research, Inc., ADHD is the 12 thmost prevalent therapeutic indication for dispensed prescriptions and is predicted to grow at a 6.4% compounded annual growth rate until 2030. Despite CII classification and black box warnings and safety liabilities, Vyvanse, Takeda’s branded ADHD medication, generated approximately $3.01 billion in global sales during fiscal year 2023, which ended on March 31, 2024. In August 2023, Vyvanse lost market exclusivity in the United States, resulting in the introduction of multiple generic alternatives. This loss of exclusivity contributed to a decline in sales, and Takeda has projected a further decrease of approximately 47% in Vyvanse revenue for fiscal year 2024 due to increased generic competition. Furthermore, based on a report from LifeSci Capital, it is estimated that CNS stimulants — amphetamine and methylphenidate containing products, represent approximately 90% of all ADHD drug sales. Across the lifespan, ADHD may impede cognitive functioning as well as mental health and development and can have a significant social impact on patient’s lives, causing disruption at school, work, and in relationships and can also be associated with risk -takingor criminal behavior and other far -reachingeffects on wider society. Over the past eight years, ADHD diagnoses have increased 30% in the United States, a trend indicating the need to focus on the diagnosis and treatment for a growing number of patients. 182 The Centers for Disease Control and Prevention, or the CDC, reported that 6.1 million, or 9.4%, of children and adolescents in the United States have ever been diagnosed with ADHD and 5.4 million, or 8.4%, have a current diagnosis, and 62% take medication, while 47% receive behavioral therapy and 23% receive no treatment at all