Shares of Agora, Inc. (API) surged 5.29% on Tuesday's intraday trading session, as the biopharmaceutical company announced the completion of its final FDA-required study for its lead asset CTx-1301, a potential new treatment for Attention Deficit Hyperactivity Disorder (ADHD).
The company reported that the food effect study on its highest 50mg dosage of CTx-1301 did not reveal any serious adverse events. This study aimed to determine if the medication can be taken with or without food, a crucial factor for ensuring optimal treatment outcomes.
With the completion of this final study, Agora is now targeting the submission of a New Drug Application (NDA) for CTx-1301 to the FDA by mid-2025. The company believes CTx-1301, utilizing its proprietary Precision Timed Release (PTR) drug delivery platform, has the potential to be the first true once-daily stimulant medication for treating ADHD throughout an entire active day.