Cingulate Said We Received Guidance From The FDA Regarding Its Clinical Program For CTX-1301 its Lead Investigational Product Candidate For The Treatment Of ADHD. Based On This Guidance, We Expect To Submit The NA For CTX-1301 In H1 2025
Portfolio Pulse from Charles Gross
Cingulate has received guidance from the FDA on its clinical program for CTX-1301, the company's lead investigational product for ADHD treatment. The company anticipates submitting the New Drug Application (NDA) for CTX-1301 in the first half of 2025, as per the recent 8-K filing.
December 28, 2023 | 11:29 am
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Cingulate has received positive feedback from the FDA regarding CTX-1301, which is expected to lead to an NDA submission in H1 2025.
The FDA's guidance is a crucial step in drug development, indicating that Cingulate is on the right track with CTX-1301. This news is likely to be viewed positively by investors as it clarifies the regulatory pathway and timeline for the potential market entry of CTX-1301. The anticipation of an NDA submission can create positive sentiment around Cingulate's stock in the short term.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 100