Curated News
By: NewsRamp Editorial Staff
May 31, 2026
Cingulate's ADHD Drug CTx-1301 Advances Toward 2026 FDA Decision
TLDR
- Cingulate's CTx-1301 FDA approval pathway positions investors to capitalize on the large ADHD market with potential valuation gains up to $31.44 per share.
- Cingulate's PTR platform delivers three timed dexmethylphenidate releases in a once-daily tablet, achieving rapid onset and full-day symptom control through defined clinical pathways.
- CTx-1301 addresses unmet ADHD treatment needs by providing rapid onset and entire active-day symptom control, improving daily functioning for patients and families.
- Cingulate's innovative PTR technology platform can scale across multiple neuropsychiatric conditions, expanding beyond ADHD to anxiety disorders with future pipeline candidates.
Impact - Why it Matters
The advancement of CTx-1301 represents a potential breakthrough in ADHD treatment, addressing the critical need for medications that provide both rapid onset and sustained full-day symptom control. For the approximately 6 million children and 10 million adults in the U.S. living with ADHD, current treatments often involve trade-offs between quick relief and duration of effect, requiring multiple doses or supplemental medications. CTx-1301's innovative triple-release technology could significantly improve treatment adherence and quality of life for patients while reducing the burden on caregivers and educators. The successful development and potential approval of this medication could establish a new standard in ADHD care and validate Cingulate's PTR platform for broader application across neuropsychiatric conditions, potentially transforming treatment approaches for millions of patients worldwide.
Summary
Stonegate Capital Partners has updated its coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's significant progress in advancing CTx-1301 toward becoming a commercial ADHD treatment franchise. The biopharmaceutical company achieved several critical milestones in the third quarter of 2025, including FDA acceptance of the CTx-1301 New Drug Application with a PDUFA target action date of May 31, 2026. Cingulate also presented positive pediatric Phase 3 data demonstrating rapid onset and full-day symptom control, while securing an exclusive commercial supply agreement with Bend Bio Sciences to ensure U.S. manufacturing capacity ahead of potential launch. These developments position CTx-1301 to address unmet needs in the substantial U.S. ADHD market, with a potential 2026 launch pending regulatory approval.
The regulatory pathway shows promising momentum as the FDA accepted the NDA under the 505(b)(2) pathway, including comprehensive adult and pediatric Phase 3 data plus required clinical and chemistry, manufacturing, and controls elements. Cingulate's innovative PTR platform delivers three timed releases of dexmethylphenidate in a once-daily tablet designed for rapid onset and complete active-day coverage. Beyond CTx-1301, the company is advancing CTx-1302 for patients who respond better to amphetamine-based stimulants and progressing CTx-2103 for anxiety disorders, demonstrating the scalability of their PTR technology across major neuropsychiatric indications. The company's leadership team has been strengthened with the appointment of industry veteran Bryan Downey as Chief Commercial Officer to lead launch preparation and go-to-market strategy.
Financially, Cingulate reported $6.1 million in cash and cash equivalents as of 3Q25, with research and development expenses increasing to $2.8 million year-over-year, reflecting continued investment in late-stage development and launch readiness. The company secured a $6.0 million unsecured promissory note post-quarter-end, extending its cash runway into the second quarter of 2026. Stonegate Capital Partners' valuation analysis using a Discounted Cash Flow model returns a valuation range of $15.29 to $31.44 with a midpoint of $21.86, indicating significant potential upside from current trading levels as the company approaches potential FDA approval and commercial launch.
Source Statement
This curated news summary relied on content disributed by Reportable. Read the original source here, Cingulate's ADHD Drug CTx-1301 Advances Toward 2026 FDA Decision
