Should you sell your Cingulate stock?

In a Sept. 18 report, Roth Capital Markets analyst Boobalan Pachaiyappan reiterated a “Buy” rating and US$10.00 target on Cingulate (Cingulate Stock Quote, Chart, News, Analysts, Financials NASDAQ:CING), citing progress toward commercialization of its lead ADHD therapy CTx-1301 and the company’s strengthened supply chain.

On Sept. 17, Cingulate announced an exclusive manufacturing partnership with Bend Bio Sciences to supply CTx-1301 in the U.S. through 2028, pending regulatory approval.

“This agreement, in conjunction with a non-binding partnership with Indegene, bodes favorably for CTx-1301’s U.S. commercial launch in 2026, pending FDA approval, in our view,” Pachaiyappan said.

Terms of the Bend deal were not disclosed.

The company submitted a New Drug Application for CTx-1301 on July 31. The U.S. Food and Drug Administration is expected to issue an acceptance decision letter by early October, determining whether the filing is complete and ready for full review. If accepted, the agency will assign a Prescription Drug User Fee Act (PDUFA) action date.

“It appears management committed to gaining the FDA’s acceptance of their NDA next month,” Pachaiyappan said.

CTx-1301 is a proprietary trimodal formulation of dexmethylphenidate designed to provide three drug-release pulses (35%-45%-20%), enabling a rapid onset of action in under 30 minutes and up to 16 hours of efficacy. The third pulse, delivered about seven hours after administration, could eliminate the need for midday booster doses that roughly 60% of ADHD patients typically require.

“In our view, this could be a compliance advantage,” he said, adding that available data also point to a favorable safety profile.

While CTx-1301 has shown promise, questions remain around the regulatory review. A Phase 3 adult trial involving 21 patients failed to achieve statistical significance (p=0.089), though the drug produced industry-leading effect sizes of 1.79 compared with ~0.7 for peer treatments. A pediatric study, terminated early after enrolling 103 of a planned 385 patients, nonetheless demonstrated clinical meaningfulness and high statistical significance (p<0.017).

“While we are optimistic about CTx-1301, it remains to be seen how the FDA will view these outcomes,” Pachaiyappan said.

Kansas-based Cingulate is a late-stage biopharmaceutical company focused on developing proprietary formulations of off-patent drugs to address unmet needs in ADHD and other conditions.

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