Curated News
By: NewsRamp Editorial Staff
July 31, 2025
Cingulate Submits ADHD Drug NDA, Eyes 2026 FDA Decision
TLDR
- Cingulate Inc's NDA submission for CTx-1301 positions it to capture a significant share of the ADHD market with its differentiated once-daily dosing advantage.
- Cingulate's Precision Timed Release platform enables true once-daily dosing through nine clinical studies supporting their FDA application filed in July 2025.
- Cingulate's ADHD treatment CTx-1301 addresses unmet patient needs by providing full-day coverage and improving medication adherence for better daily functioning.
- Cingulate's PTR technology platform expands beyond ADHD to anxiety disorders, demonstrating scalable innovation in psychiatric treatment development.
Impact - Why it Matters
This development matters because ADHD affects millions of children and adults worldwide, many of whom struggle with current treatment options that require multiple daily doses or cause inconsistent symptom control. Cingulate's Precision Timed Release technology promises true once-daily dosing that could significantly improve medication adherence and quality of life for patients. If approved, CTx-1301 would represent the first product from this innovative platform, potentially setting a new standard in ADHD treatment while opening doors for similar approaches in other psychiatric conditions like anxiety disorders. The company's progress also signals ongoing innovation in neuropsychiatric pharmaceuticals, addressing substantial unmet needs in mental healthcare.
Summary
Cingulate Inc. (NASDAQ: CING) has achieved a significant regulatory milestone with the submission of its New Drug Application (NDA) to the FDA for its lead ADHD asset, CTx-1301, marking a pivotal moment for the company's innovative Precision Timed Release™ (PTR™) platform. The NDA, filed on July 31, 2025, incorporates data from nine clinical studies including pivotal pediatric and adult trials, positioning CTx-1301 as a potential game-changer in ADHD treatment with true once-daily dosing capability. With the FDA expected to decide on acceptance by 4Q25 and a potential PDUFA date in mid-2026, Cingulate is advancing commercialization readiness while managing its financial strategy through a recently expanded $25 million purchase agreement with Lincoln Park Capital.
The company's pipeline extends beyond CTx-1301, with CTx-1302 (dextroamphetamine) using the same PTR™ technology for amphetamine-responsive patients and early-stage candidate CTx-2103 targeting anxiety disorders, demonstrating the platform's scalability across psychiatric markets. Financially, Cingulate reported $8.9 million in cash and $3.5 million in working capital as of 2Q25, though increased R&D expenses of $2.7 million (up 44% year-over-year) and G&A costs of $1.9 million (up 47%) reflect the intensive NDA preparation phase. Leadership changes include Jennifer Callahan's appointment as Interim CEO while continuing as CFO, and industry veteran Jay Roberts as Executive Chairman, providing stability during this critical pre-commercial phase as Stonegate Capital Partners maintains coverage with a valuation range of $15.03 to $30.46.
Source Statement
This curated news summary relied on content disributed by Reportable. Read the original source here, Cingulate Submits ADHD Drug NDA, Eyes 2026 FDA Decision
