Soleno Therapeutics Announces FDA Acceptance For Filing And Priority Review Of Its NDA For DCCR Extended-Release Tablets For Prader-Willi Syndrome
Portfolio Pulse from Benzinga Newsdesk
Soleno Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for DCCR extended-release tablets, intended for the treatment of Prader-Willi Syndrome, and granted it priority review.
August 27, 2024 | 12:12 pm
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Soleno Therapeutics' NDA for DCCR tablets for Prader-Willi Syndrome has been accepted by the FDA and granted priority review, indicating a potentially faster approval process.
The FDA's acceptance and priority review of Soleno's NDA for DCCR tablets is a significant regulatory milestone, suggesting a faster path to market. This development is likely to boost investor confidence and positively impact SLNO's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100