Cingulate posts Q2 loss, plans ADHD drug FDA resubmission
Biopharma firm Cingulate reported a second-quarter loss and outlined plans to resubmit its ADHD treatment to the FDA after addressing prior deficiencies.
Cingulate Inc. on Friday reported a net loss for the second quarter as it prepares to resubmit its experimental attention-deficit/hyperactivity disorder drug to U.S. regulators.
The company did not disclose the magnitude of the loss but stated it remains focused on addressing deficiencies identified in previous communications with the U.S. Food and Drug Administration. Cingulate said it expects to submit a resubmission package to the FDA by the end of the year, pending completion of required steps.
The planned resubmission follows a complete response letter issued by the FDA in 2023, which outlined deficiencies related to manufacturing and clinical data for the drug, CTx-1301. Cingulate has since worked to address these concerns, including updating manufacturing processes and providing additional clinical data.
CTx-1301 is designed to deliver a controlled release of amphetamine, a stimulant commonly used to treat ADHD. The drug is intended as a once-daily, extended-release oral treatment. Cingulate has not yet provided a revised timeline for potential FDA approval, citing ongoing regulatory interactions.
Shares of Cingulate were down 5% in after-hours trading following the announcement.
Priya covers listed equities and corporate earnings, reading quarterly results and guidance for what they signal about sector health and forward valuations.
More from Priya Anand →