Cingulate’s ADHD drug meets primary endpoints in phase 3 trial

KANSAS CITY, Kan. - Cingulate Inc. (NASDAQ:CING), a clinical-stage biopharmaceutical company with a market capitalization of $21 million, announced Tuesday that its experimental ADHD medication CTx-1301 met primary endpoints in a pivotal Phase 3 trial involving children and adolescents. According to InvestingPro data, the company currently maintains more cash than debt on its balance sheet, though it’s rapidly burning through available funds.

The once-daily dexmethylphenidate HCl formulation demonstrated dose-dependent improvements on the ADHD ratings scale and Clinical Global Impression-Severity scales, according to results presented by Dr. Ann Childress at the AACAP Annual Meeting in Chicago.

In the randomized, double-blind, placebo-controlled study, CTx-1301 showed rapid onset of effect with sustained efficacy through evening hours. The 37.5mg dose demonstrated the largest effect size in symptom reduction. Safety and tolerability were consistent with other methylphenidate medications, with no unexpected adverse events reported.

"These results demonstrate that CTx-1301 can deliver reliable symptom control for the entire active-day in a single dose," said Raul Silva, Chief Science Officer of Cingulate, according to the company’s press release.

The drug utilizes Cingulate’s Precision Timed Release platform to deliver three precisely timed releases of medication throughout the day, potentially addressing a key challenge in ADHD treatment where most extended-release formulations require multiple daily doses.

The FDA accepted Cingulate’s New Drug Application for CTx-1301 earlier this month with a target decision date of May 31, 2026. The company also received a waiver of the standard filing fee, saving approximately $4.3 million. Wall Street analysts maintain optimistic price targets ranging from $8 to $62, though InvestingPro analysis indicates the stock is currently overvalued. InvestingPro subscribers have access to 8 additional key insights about Cingulate’s financial health and market position.

Cingulate has established a commercial partnership with Indegene, a life sciences commercialization company, in preparation for potential market launch.

ADHD affects an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults, representing a $23 billion global market according to the company. With a negative EBITDA of $17.2 million in the last twelve months and a beta of -0.75, indicating movement contrary to broader market trends, Cingulate faces significant challenges in capturing market share. InvestingPro data reveals the company’s overall financial health score as weak, an important consideration for investors monitoring this development.

The biopharmaceutical company plans to share additional details from the Phase 3 study in upcoming scientific publications.

In other recent news, Cingulate Inc. has announced that the U.S. Food and Drug Administration has accepted its New Drug Application for CTx-1301, a treatment for ADHD, with a target action date set for May 31, 2026. Additionally, Cingulate has secured a manufacturing agreement with Bend Bio Sciences, which will be the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, contingent on FDA approval. The company also reported issuing 325,729 shares of its common stock in a series of unregistered transactions to settle debt with a lender. Changes in executive leadership were also disclosed, with John A. Roberts appointed as executive chairman while CEO Shane Schaffer was placed on administrative leave. In terms of stock analysis, Ascendiant Capital has raised its price target for Cingulate to $62, maintaining a Buy rating on the stock. These developments highlight the ongoing strategic and operational activities at Cingulate.

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