Cingulate Retail Buzz Surges As ADHD Drug Shows Phase 3 Pediatric Efficacy

Retail chatter around Cingulate spiked Tuesday after Phase 3 data confirmed that its lead candidate, CTx-1301, significantly improved ADHD symptoms in pediatric patients within five weeks of treatment.

At Tuesday's close, Cingulate shares fell 4.99% to $3.62 and slipped further 1.66% to $3.56 in after-hours trading.

According to the Kansas-based biotech, children who took CTx-1301 at doses of 18.75 mg, 25 mg, and 37.5 mg experienced significant reductions in their ADHD-RS-5 scores.

Dr. Raul Silva, chief science officer at Cingulate, revealed the possibility of CTx-1301 becoming a primary treatment option for ADHD after demonstrating effect sizes between 0.737 and 1.185, which surpass the industry standard of 0.73 for long-duration stimulants.

CEO Shane Schaffer identified the findings as a “significant value inflection point” while confirming that the company plans to file a New Drug Application (NDA) this summer.

CTx-1301 uses Cingulate’s Precision Timed Release platform to provide a single daily dose, which begins working in the morning and maintains effectiveness throughout the day.

After receiving FDA approval, the company plans to offer eight different dosage strengths to address the pediatric and adult ADHD markets.

On Stocktwits, retail sentiment was ‘extremely bullish’ amid a 2,700% surge in 24-hour message volume.

One user highlighted the forthcoming FDA submission as a key milestone and suggested that the recent decline in share price may offer a buying opportunity. 

Another user was more cautious, noting that the effect size observed in the pediatric trial appeared lower than earlier projections. However, they acknowledged that sustained efficacy throughout the day could remain a key differentiator.

The stock has declined 29% so far in 2025.

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