FDA Grants Priority Review for Potential Prader-Willi Syndrome Treatment

  • Soleno Therapeutics’ shares advanced after FDA granted priority review for diazoxide choline application
  • Priority review designated for drugs providing significant improvement in safety or effectiveness for serious conditions
  • FDA assigned a PDUFA target action date of Dec. 27
  • Diazoxide choline has breakthrough and fast-track designations, as well as orphan drug status

Soleno Therapeutics has seen a boost in its shares after the FDA granted priority review for diazoxide choline, a potential treatment for individuals with Prader-Willi syndrome aged four and above who suffer from hyperphagia. The company’s shares increased by 7.8% to $49.72, marking a 25% advance this year. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 27th. Diazoxide choline holds breakthrough and fast-track designations, as well as orphan drug status in both the U.S. and E.U.

Image Credits: no
Factuality Level: 10
Factuality Justification: The article provides accurate information about the FDA’s approval of Soleno Therapeutics’ new drug application for diazoxide choline, its trading performance, and the assigned action date. It also mentions the priority review designation and the company’s previous designations for the drug.
Noise Level: 1
Noise Justification: The article provides relevant information about a specific company’s stock performance and FDA actions related to a new drug application, but it lacks broader context or analysis of the implications for the industry or the condition being treated.
Public Companies: Soleno Therapeutics ()
Key People: Robb M. Stewart (Author)

Financial Relevance: Yes
Financial Markets Impacted: Soleno Therapeutics’ shares
Financial Rating Justification: The article discusses the impact of FDA’s decision on Soleno Therapeutics’ shares and the company’s financial performance, making it relevant to financial topics and markets.
Presence Of Extreme Event: No
Nature Of Extreme Event: Other
Impact Rating Of The Extreme Event: No
Extreme Rating Justification: There is no extreme event mentioned in the article.
Move Size: 7.8%
Sector: Healthcare
Direction: Up
Magnitude: Large
Affected Instruments: Stocks

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