Citing production issues, the US FDA has rejected Cingulate's (CING.O) application for ADHD medication approval, a decision announced on Tuesday by the company in a new statement.
The FDA expressed no reservations regarding the medication's efficacy or safety profile in a recent correspondence with Cingulate.
Related ↗A powerful earthquake measuring 7.8 magnitude hits the south of Philippines.Cingulate's recent announcement about its manufacturing partner receiving FDA notes has significant implications for the development of their ADHD medication, CTx-1301.
Kansas-based Cingulate shares bounced back by almost 17%, despite a significant decline.
Read next ↗New Obesity Treatment from Boehringer-Zealand Reduces Visceral Liver Fat Effectively.Maxim Group analyst Naz Rahman noted that the FDA had no issues with the drug's effectiveness or risk profile.
CTx-1301 approval would insert it into a competitive market, where several generic stimulants and branded medications like Takeda Pharmaceutical's (4502.T) Vyvanse and Johnson & Johnson's (JNJ.N) Concerta are already vying for attention. This sector has been plagued by shortages since October 2022 due to manufacturing setbacks and skyrocketing demand.
The US Drug Enforcement Administration boosted the production quota for Vyvanse and its generics in September 2024 by a significant 24%.
Dexmethylphenidate, a key component in several FDA-approved ADHD medications, has been formulated as a once-daily tablet to address ADHD symptoms such as persistent inattention, excessive hyperactivity, and impulsivity that can persist from childhood into adulthood.
Dopamine and norepinephrine levels are increased by dexmethylphenidate, two neurotransmitters directly linked to focus and conduct regulation. As a Schedule II controlled substance, it necessitates a medical professional's written authorization for dispensing.
Existing ADHD medications often experience a notable decline in effectiveness mid-day, prompting concerns about patient compliance.
Promptly submitting additional data to the FDA is a priority for the company, with approximately $30 million in reserve to cover both resubmission costs and operational expenses through next year's end.
According to Zacks Small-Cap Research analyst John Vandemosten, projected peak sales stand at approximately $1 billion by 2043.
Citing production issues,the US FDA has rejected Cingulate's (CING.O) application for ADHD medication approval, a decision announced on Tuesday by the company in a new statement.
