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KANSAS CITY, Kan. - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company with a market capitalization of $13 million, announced the submission of Phase 3 safety data for CTx-1301, its lead ADHD treatment candidate, to the FDA ahead of a key meeting on April 2, 2025. While the company maintains a healthy current ratio of 7.35 and minimal debt, InvestingPro analysis indicates rapid cash utilization in its development programs. The company’s data encompasses results from two pediatric and adolescent studies and a food effect study with healthy adults.
The studies aimed to evaluate the safety of CTx-1301, a proposed once-daily stimulant medication for ADHD. According to the press release, no serious treatment emergent adverse events, serious adverse events, or deaths were reported. Additionally, no significant trends in treatment emergent adverse events were identified. With the stock trading at $3.95, analysts maintain price targets ranging from $8 to $75, suggesting potential upside if clinical development succeeds.
The pediatric and adolescent studies included both a fixed dose and a dose optimization study, while the food effect study assessed the pharmacokinetics of a single 50mg dose of CTx-1301, indicating that it could be taken with or without food.
Cingulate’s Chairman and CEO, Shane J. Schaffer, expressed satisfaction with the consistent safety profile demonstrated across nine clinical trials. The company anticipates the upcoming FDA meeting as a precursor to their new drug application submission slated for the summer.
Dr. Ann C. Childress, an ADHD expert and lead investigator for the Phase 3 trials, highlighted the potential benefits of CTx-1301, citing its ability to address unmet needs in ADHD treatment without the need for booster doses.
CTx-1301 utilizes Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three releases of medication throughout the day in a single tablet. This aims to provide rapid onset and entire active-day efficacy for patients. InvestingPro subscribers can access 12 additional investment tips and comprehensive financial metrics to evaluate the company’s development potential.
ADHD affects millions of individuals in the U.S., with a significant number continuing to experience symptoms into adulthood. Current treatments often require multiple doses, which can lead to adherence issues and potential for abuse.
The company’s PTR technology is also being explored for developing additional product candidates in other therapeutic areas beyond ADHD and anxiety disorders. Based on InvestingPro Fair Value analysis, the stock currently appears undervalued, though investors should note the company’s weak overall financial health score of 1.71 and year-to-date decline of nearly 20%.
This article is based on a press release statement from Cingulate Inc.
In other recent news, Cingulate Inc. has made several notable announcements that could interest investors. The company reported the resolution of charges against its CEO, Shane Schaffer, who continues to have the full support of the Board of Directors. This development was disclosed in a Form 8-K filing with the Securities and Exchange Commission. Additionally, H.C. Wainwright has raised its price target for Cingulate to $20, up from $8, while maintaining a Buy rating. This update follows the completion of a key clinical program for Cingulate’s ADHD treatment, CTx-1301, which showed no serious adverse events in its food effect study.
Moreover, Cingulate has adjusted its executive compensation structure, particularly for Executive Vice President and Chief Medical (TASE:BLWV) Officer, Matthew N. Brams, whose annual base salary is now set at $165,000, with changes to his equity grant entitlements. Roth/MKM has also initiated coverage on Cingulate with a Buy rating and a $12 price target, citing the promising Phase 3 data of CTx-1301. The analyst at Roth/MKM projects that CTx-1301 could achieve sales of $1.6 billion by 2035, highlighting its potential impact on the ADHD market. Cingulate’s current cash position is expected to sustain its operations into the third quarter of 2025, with a New Drug Application for CTx-1301 anticipated in mid-2025.
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