15% Pre-Market Slide on FDA Extension

  • Syndax Pharmaceuticals’ shares fall nearly 15% in premarket trading
  • FDA extends review of revumenib
  • Additional information submitted as major amendment to application
  • Target action date extended from Sept. 26 to Dec. 26

Shares of Syndax Pharmaceuticals dropped by nearly 15% in premarket trading after the FDA extended its review of the clinical-stage biopharmaceutical company’s proposed leukemia drug revumenib. The Food and Drug Administration determined that additional information submitted at their request constituted a major amendment to Syndax’s application seeking approval for revumenib as a treatment for relapsed or refractory KMT2Ar acute leukemia, resulting in a three-month extension of the target action date from Sept. 26 to Dec. 26. Notably, the FDA did not request any additional trials or manufacturing information.

Factuality Level: 8
Factuality Justification: The article provides accurate and objective information about the FDA’s decision to extend its review of Syndax Pharmaceuticals’ drug application, the reason for the extension, and the impact on the company’s stock price. It also mentions that no additional trials or manufacturing information was requested by the FDA.
Noise Level: 3
Noise Justification: The article provides relevant and accurate information about the FDA’s decision on Syndax Pharmaceuticals’ drug application, but it lacks analysis or exploration of long-term trends or consequences. It also doesn’t offer actionable insights or new knowledge for readers.
Public Companies: Syndax Pharmaceuticals (SNDX)
Key People: Colin Kellaher (Author)

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Financial Relevance: Yes
Financial Markets Impacted: Syndax Pharmaceuticals’ stock
Financial Rating Justification: The article discusses the impact of the FDA’s decision on Syndax Pharmaceuticals’ stock price and its clinical-stage biopharmaceutical company, which is related to financial markets as it affects the company’s stock performance.
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Extreme Rating Justification: There is no extreme event mentioned in the article.

Reported publicly: www.marketwatch.com