Soleno Therapeutics Announces FDA Review Division Determined That There Does Not Appear To Be A Need For An Advisory Committee Meeting At This Time For The NDA For DCCR Extended-Release Tablets For The Treatment Of Prader-Willi Syndrome
Portfolio Pulse from Benzinga Newsdesk
Soleno Therapeutics announced that the FDA has determined there is no immediate need for an advisory committee meeting for the NDA of DCCR tablets for Prader-Willi syndrome. The FDA will continue to review the application.
October 08, 2024 | 12:43 pm
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POSITIVE IMPACT
Soleno Therapeutics' NDA for DCCR tablets for Prader-Willi syndrome is under FDA review, with no immediate need for an advisory committee meeting. This suggests a smoother regulatory path, potentially boosting investor confidence.
The FDA's decision not to require an advisory committee meeting at this stage suggests a positive outlook for the NDA process, which could lead to a smoother approval path. This is likely to boost investor confidence in Soleno Therapeutics, potentially leading to a short-term increase in stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100