Stonegate Capital Partners Updates Coverage on Cingulate Inc. (CING) 2Q25
Rhea-AI Summary
Cingulate Inc. (NASDAQ: CING) received updated coverage from Stonegate Capital Partners following their Q2 2025 results. The company has made significant progress with its lead ADHD treatment CTx-1301, submitting its New Drug Application (NDA) to the FDA on July 31, 2025. The company expects FDA acceptance in Q4 2025 with a potential PDUFA date in mid-2026.
The company's innovative Precision Timed Release (PTR) platform aims to improve ADHD treatment through true once-daily dosing. Financial position shows $8.9M in cash and $3.5M in working capital, sufficient to fund operations into late 2025. Phase 3 pediatric trial and fed/fast study demonstrated positive results, while commercialization preparations continue with Indegene for a planned mid-2026 launch.
Positive
- Successful submission of NDA for CTx-1301 to FDA
- Positive Phase 3 pediatric trial results
- Strong efficacy and flexible dosing demonstrated in fed/fast study
- $8.9M cash position funding operations into late 2025
Negative
- Limited cash runway extending only into late 2025
- Potential need for additional funding before commercial launch in mid-2026
News Market Reaction 2 Alerts
On the day this news was published, CING gained 5.01%, reflecting a notable positive market reaction. Argus tracked a trough of -3.3% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $23M at that time.
Data tracked by StockTitan Argus on the day of publication.
Dallas, Texas--(Newsfile Corp. - August 21, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 2Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301. The Company remains focused on advancing its Precision Timed Release (PTR) platform, designed to address gaps in current ADHD treatments by enabling true once-daily dosing. With a differentiated product profile and a large U.S. market opportunity, management is preparing for commercialization while also evaluating opportunities to broaden its global footprint through strategic partnerships.
To view the full announcement, including downloadable images, bios, and more, click here.
Key Takeaways:
Cingulate submitted its NDA for CTx-1301 on July 31, 2025, with FDA acceptance expected in 4Q25 and a potential PDUFA date in mid-2026.
CING ended 2Q25 with
$8.9M in cash and$3.5M in working capital, funding operations into late 2025.Positive results from the Phase 3 pediatric trial and fed/fast study reinforced CTx-1301's strong efficacy and flexible dosing, while commercialization planning with Indegene is underway to prepare for a mid-2026 launch.
Click image above to view full announcement.
About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.
Contacts:
Stonegate Capital Partners
(214) 987-4121
info@stonegateinc.com
Source: Stonegate, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263418
FAQ
When did Cingulate (CING) submit its NDA for CTx-1301?
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When is the expected PDUFA date for Cingulate's (CING) CTx-1301?
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