Stonegate Capital Partners Initiates Coverage on Cingulate Inc., Highlighting Potential in ADHD Treatment Market
TL;DR
Cingulate Inc.'s CTx-1301 offers a competitive edge in the $22B U.S. ADHD market with its once-daily, rapid-onset therapy, potentially outperforming existing treatments requiring booster doses.
Cingulate Inc. utilizes its Precision Timed Release™ platform to develop CTx-1301, a once-daily ADHD treatment with proven efficacy across multiple dose levels in Phase 3 trials.
CTx-1301 by Cingulate Inc. aims to improve ADHD treatment by offering a full-day effective therapy, enhancing patient adherence and quality of life without the need for booster doses.
Discover how Cingulate Inc.'s innovative CTx-1301 could revolutionize ADHD treatment with its unique once-daily formula, backed by positive Phase 3 trial results.
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Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), spotlighting the company's advancements in the ADHD treatment sector with its lead asset, CTx-1301. This development is significant as CTx-1301, leveraging Cingulate's proprietary Precision Timed Release™ (PTR™) platform, aims to address critical gaps in current ADHD therapies by offering a once-daily stimulant with rapid onset and sustained efficacy throughout the day.
The coverage comes on the heels of Cingulate's announcement of positive Phase 3 pediatric study results for CTx-1301, demonstrating statistically significant improvements in ADHD symptoms across all tested doses. Additionally, the high-dose food effect study confirmed the treatment's flexibility, enhancing patient adherence. These findings underscore the potential of CTx-1301 to set a new standard in ADHD care, pending FDA approval.
Cingulate is preparing for the commercial launch of CTx-1301, targeting the lucrative $22B U.S. ADHD market. The company is also exploring out-licensing opportunities internationally and scaling up for product launch. With an NDA submission planned for mid-2025, Cingulate is at a pivotal juncture, backed by a strong safety profile and efficacy data from nine clinical trials.
Financially, Cingulate faces challenges with a reported net loss of $3.8M in 1Q25 and an operating cash burn of $4.6M. However, strategic financing efforts, including a recent $5M promissory note, aim to support the company through critical regulatory milestones. The initiation of coverage by Stonegate Capital Partners highlights the growing interest in Cingulate's innovative approach to ADHD treatment and its potential impact on patients and the healthcare industry.
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