This analyst just raised his price target on Cingulate

Roth Capital Markets analyst Boobalan Pachaiyappan raised his target price on Cingulate (Cingulate Stock Quote, Chart, News, Analysts, Financials NASDAQ:CING) to US$17 .00 from US$10.00 while reiterating a “Buy” rating in an Oct. 14 update, citing the U.S. FDA’s acceptance of the company’s New Drug Application for its once-daily ADHD therapy, CTx-1301, as a strong regulatory signal.

“The FDA’s acceptance of Cingulate’s NDA package suggests the agency is comfortable with the safety and efficacy profile of CTx-1301 in ADHD patients,” Pachaiyappan said. “The lack of an advisory committee meeting, an earlier-than-expected PDUFA date, a potential broad label for patients aged six and up, and the historically strong approval record for ADHD stimulants are all good reasons to own the stock, especially at current levels.”

The Kansas-based biopharmaceutical company develops proprietary formulations of established drugs to address unmet needs in ADHD and related conditions. CTx-1301, its lead program, uses a novel tri-pulse methylphenidate delivery system designed to provide consistent therapeutic coverage over a full 14–16-hour active day, eliminating the need for mid-day booster doses that roughly 60% of ADHD patients currently require.

Pachaiyappan said the FDA’s review process revealed no major deficiencies, with only standard manufacturing information requests raised during the two-month evaluation period. He noted the agency’s decision to set a May 31, 2026, PDUFA action date, two months earlier than expected, “effectively buys additional exclusivity time, providing an incremental commercialization benefit.”

He added that the absence of an advisory committee meeting indicates regulatory confidence in the CTx-1301 data package, particularly given the drug’s differentiated delivery profile.

“If approved, CTx-1301 would likely be indicated for patients aged six and older,” he said, highlighting the flexibility provided by its eight available dosage strengths, which allow physicians to tailor treatment to individual needs.

Roth now models FDA approval by May 2026 and a U.S. launch in 1H27, potentially through a commercialization partnership with Indegene, projecting peak sales of US$1.6-billion by 2035 before expected generic entry in 2036.

Pachaiyappan said CTx-1301’s design could drive strong adoption by addressing key pain points with existing long-acting stimulants, particularly reducing crash and rebound symptoms and simplifying dosing.

“These attributes should resonate with both patients and physicians,” he said, noting that the muted 2.5% stock gain following the FDA announcement likely reflected anticipation of a capital raise and underappreciation of the product’s value in a crowded ADHD market.

“In our view, today’s share price represents a compelling entry point,” he said, adding that all ADHD stimulants that have reached NDA review in the past 50 years were ultimately approved.

“CTx-1301 could offer a meaningful compliance advantage to the 60% of ADHD patients who currently require a mid-day booster dose.”

Following the NDA acceptance, Roth increased its probability of approval for pediatric and adolescent use from 40% to 50%, raising its modelled valuation to US$108-million, which supports the 12-month target price of US$17 per share.

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