Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome
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Soleno Therapeutics announced that the FDA has extended the review period for its New Drug Application for DCCR tablets, aimed at treating Prader-Willi syndrome. This extension may delay the potential approval and market entry of the drug.
November 26, 2024 | 1:45 pm
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The FDA has extended the review period for Soleno Therapeutics' DCCR tablets, which may delay the drug's approval and market entry, potentially impacting the company's stock price negatively in the short term.
The extension of the FDA review period suggests a delay in the potential approval and commercialization of Soleno's DCCR tablets. This could lead to a negative short-term impact on Soleno's stock price as investors may react to the uncertainty and potential delay in revenue generation.
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