Stonegate Capital Partners Updates Coverage on Cingulate Inc. (CING) 3Q25
Rhea-AI Summary
Cingulate (NASDAQ: CING) updated 3Q25 progress as it advances CTx-1301 toward a potential commercial ADHD launch. Key developments include FDA acceptance of the CTx-1301 NDA with a May 31, 2026 PDUFA date, presentation of positive pediatric Phase 3 data showing rapid onset and full active‑day symptom control, and an exclusive U.S. supply agreement with Bend Bio Sciences to secure manufacturing capacity.
Commercial build continues with a new Chief Commercial Officer, an Indegene partnership, quarter‑end cash of ~$6.1M, and a post‑quarter $6M financing that the company says extends runway into 2Q26.
Positive
- NDA accepted with May 31, 2026 PDUFA
- Positive pediatric Phase 3 data: rapid onset, full active‑day control
- Exclusive supply agreement with Bend Bio Sciences secures U.S. manufacturing
- $6M post‑quarter financing extended runway into 2Q26
- Commercial hires and partnerships advancing launch preparedness
Negative
- Quarter‑end cash roughly $6.1M indicates limited near‑term liquidity
- 2026 launch is contingent on FDA approval, not guaranteed
News Market Reaction
On the day this news was published, CING gained 1.18%, reflecting a mild positive market reaction. This price movement added approximately $262K 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. - November 18, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate's 3Q25 results reflect continued progress toward transforming CTx-1301 into a commercial ADHD franchise. Recently the Company achieved several key milestones, including FDA acceptance of the CTx-1301 NDA with a May 31, 2026 PDUFA date, presentation of positive pediatric Phase 3 data demonstrating rapid onset and entire active-day symptom control, and execution of an exclusive commercial supply agreement with Bend Bio Sciences to secure U.S. manufacturing capacity ahead of launch. Together with its PTR platform and focused commercial strategy, Cingulate is positioning CTx-1301 to address unmet needs in the large U.S. ADHD market as it prepares for a potential 2026 launch, subject to FDA approval.
To view the full announcement, including downloadable images, bios, and more, click here.
Key Takeaways:
- NDA for CTx-1301 accepted with a PDUFA date set for May 31, 2026 supporting a potential 2026 launch pending approval.
- Quarter end cash was ~
$6.1M and a$6M financing post quarter extended runway into 2Q26. - Commercial build advancing with Bryan Downey named Chief Commercial Officer plus Indegene partnership and Bend Bio Sciences supply to secure U.S. manufacturing.
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/275080
FAQ
What is Cingulate's CTx-1301 PDUFA date and significance for CING?
What did Cingulate report about CTx-1301 Phase 3 pediatric results for CING?
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What manufacturing arrangements has Cingulate announced for CTx-1301 (CING)?
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