Cingulate Shares Fall After Timeline Update For Its Lead Candidate In ADHD

 

• Cingulate Inc 
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   is preparing to initiate a Phase 3 adult dose-optimization study later this year for its lead candidate, CTx-1301, to assess the onset and duration of efficacy and safety in adults with Attention Deficit / Hyperactivity Disorder (ADHD). 
• The study is expected to commence in December 2022.
• The company executed a Master Services Agreement with Societal CDMO Inc 
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   to manufacture all clinical, registration, and commercial batches of Cingulate's lead candidate CTx-1301, an investigational medication for ADHD.
• In addition, the CTx-1301 Phase 3 fixed-dose pediatric and adolescent safety and efficacy study is now expected to commence in mid-2023 after the final two dosage strengths for this study are completed by Societal CDMO. 
• Earlier this year, Cingulate expected to start the fixed-dose study in Q2 of 2022.
• Assuming positive clinical results from Phase 3 trials and the food effect study with data expected in December 2022, the company plans to submit a marketing application to the FDA in 1H of 2024 under the Section 505(b)(2) pathway.

https://www.benzinga.com/general/biotech/22/10/29391292/cingulate-shares-fall-after-timeline-update-for-its-lead-candidate-in-adhd