Cingulate Inc. (CING), a biopharmaceutical company, on Tuesday announced receipt of a complete response letter (CRL) from the FDA regarding CTx-1301 for the treatment of attention deficit/hyperactivity disorder.
Following the announcement, shares rose by over 25% on Tuesday.
Attention deficit/hyperactivity disorder (ADHD) is a chronic neurobiological and developmental disorder that affects children and can continue into adulthood. There are over 20 million ADHD patients in the U.S. alone, accounting for over 100 million annual prescriptions and a growing market for adults.
CTx-1301 (dexmethylphenidate hydrochloride) was developed as a once-daily, multi-core tablet using the company's proprietary Precision Timed Release (PTR) platform to release the active medication three times across the day.
The company submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301 in October 2025, and a PDUFA target action date was set at May 31, 2026.
The CRL from the FDA contained requests for specific Chemistry, Manufacturing, and Controls (CMC) information regarding CTx-1301, but did not raise concerns over the drug's safety or efficacy.
The company stated intentions to fulfill the CMC data requirements, and reiterated its current $30 million cash position, which is expected to fund pre-commercial activities till 2027.
CING is currently trading at $4.50, up 25.01%.
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