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Cingulate Inc’s NDA for CTx-1301 Accepted by FDA

Story Highlights
  • Cingulate Inc.’s NDA for CTx-1301, an ADHD treatment, was accepted by the FDA.
  • The FDA’s acceptance marks a key milestone, positioning Cingulate for potential market entry in 2026.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Cingulate Inc’s NDA for CTx-1301 Accepted by FDA

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Cingulate Inc ( (CING) ) just unveiled an update.

On October 14, 2025, Cingulate Inc. announced that the FDA has accepted the New Drug Application for CTx-1301, a treatment for ADHD in children and adults, with a target action date set for May 31, 2026. This acceptance marks a significant regulatory milestone for Cingulate, as it transitions from a development-stage to a commercial-stage company, pending FDA approval. The NDA acceptance follows successful Phase 3 trials demonstrating CTx-1301’s efficacy and safety, and positions the company for potential market entry, supported by strategic partnerships for manufacturing and commercialization.

The most recent analyst rating on (CING) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Cingulate Inc stock, see the CING Stock Forecast page.

Spark’s Take on CING Stock

According to Spark, TipRanks’ AI Analyst, CING is a Neutral.

Cingulate Inc.’s overall stock score is primarily impacted by its poor financial performance, with persistent losses and negative cash flows. However, recent corporate developments, such as securing a grant and progress towards FDA approval, provide a positive outlook. The technical analysis shows neutral momentum, but valuation remains a concern due to financial losses and lack of dividends.

To see Spark’s full report on CING stock, click here.

More about Cingulate Inc

Cingulate Inc. is a biopharmaceutical company based in Kansas City, Kansas, specializing in the development of next-generation pharmaceutical products using its proprietary Precision Timed Release™ platform technology. The company focuses on improving patient outcomes in conditions with burdensome daily dosing and suboptimal therapeutic coverage, with its lead candidate, CTx-1301, in late-stage development for ADHD and additional candidates for anxiety and other neuropsychiatric conditions.

Average Trading Volume: 150,727

Technical Sentiment Signal: Sell

Current Market Cap: $23.04M

For a thorough assessment of CING stock, go to TipRanks’ Stock Analysis page.

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