Roth Capital said the FDA’s acceptance shows strong confidence in Cingulate’s ADHD drug, adding that its early PDUFA date and clean regulatory path make it a good investment.
Retail chatter around Cingulate picked up on Tuesday after Roth Capital Partners raised its price target to $17 from $10 and reaffirmed a ‘Buy’ rating.
Cingulate Inc.’s stock snapped a two-day losing streak, rising 2.5% to $4.15 on Tuesday, and added another 1.6% in after-hours trading.
The firm said the FDA’s acceptance of Cingulate’s application for its ADHD drug CTx-1301 signals confidence in the treatment’s safety and effectiveness for both children and adults.
Roth analysts said the absence of an Advisory Committee review, an earlier-than-expected PDUFA date of May 31, 2026, and a potentially broad label across ADHD patients all strengthen the investment case for Cingulate. They also highlighted the strong approval track record of ADHD stimulants as supportive of the drug’s prospects.
The FDA’s acceptance marks a major step forward for CTx-1301, which uses Cingulate’s proprietary Precision Timed Release technology to deliver once-daily, all-day symptom control. The company said Phase 3 data showed rapid onset and sustained efficacy with no serious safety issues reported.
The company called the FDA acceptance a “defining milestone”, positioning Cingulate to transition from a development-stage to a commercial-stage company in 2026, pending approval. The firm said commercial preparations are already underway through partnerships with Bend Bio Sciences and Indegene to ensure manufacturing scale-up and market readiness.
On Stocktwits, retail sentiment for Cingulate was ‘bullish’ amid an 820% surge in 24-hour message volume.
One bullish user highlighted the advantages of Cingulate’s regulatory route, noting it follows a faster and less expensive path typically used for drugs that build on existing approvals with new delivery methods. They noted the company’s silence on social media could hint at buyout interest and said they would only part with their shares for $27.
Another bullish user noted that, with the NDA now accepted, the real question for investors was the risk they were taking by not owning the stock at this stage. They added that long-term holders were feeling more confident than ever about the company’s direction.
Cingulate’s stock has declined 16% so far in 2025.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<