Vanda Pharmaceuticals Faces Setback in Gastroparesis Treatment Approval Process

  • FDA rejects Vanda Pharmaceuticals’ application for gastroparesis drug tradipitant
  • Additional studies required by FDA
  • Vanda believes FDA disregarded evidence from placebo-controlled trials
  • Inconsistent study design and duration according to experts’ advice

The Food and Drug Administration (FDA) has rejected Vanda Pharmaceuticals’ application for tradipitant, a drug intended to treat gastroparesis. The company received a complete response letter, indicating that the FDA won’t approve the application in its current form and requested additional studies. Vanda believes the FDA disregarded evidence from two placebo-controlled trials and stated that the suggested studies have an inconsistent design and duration compared to expert advice. The Washington biopharmaceutical company plans to file a separate application later this year for tradipitant’s use in preventing vomiting during motion sickness.

Factuality Level: 8
Factuality Justification: The article provides accurate information about Vanda Pharmaceuticals’ rejected drug application and the FDA’s request for additional studies. It also mentions the company’s plans to pursue approval for tradipitant in gastroparesis and motion sickness prevention. The language is objective and does not include sensationalism, redundancy, or personal perspective.
Noise Level: 3
Noise Justification: The article provides relevant information about the FDA’s decision on Vanda Pharmaceuticals’ proposed drug and the company’s plans to continue pursuing approval. It does not contain any irrelevant or misleading information, nor does it reinforce popular narratives without questioning them. The article stays on topic and supports its claims with evidence (the two placebo-controlled trials). However, it could provide more analysis of long-term trends or possibilities, and while it mentions the company’s plans for future action, it doesn’t offer much in terms of actionable insights or new knowledge.
Public Companies: Vanda Pharmaceuticals (VNDA)
Key People:

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Financial Relevance: Yes
Financial Markets Impacted: Vanda Pharmaceuticals
Financial Rating Justification: The article discusses the FDA’s decision on a proposed drug from Vanda Pharmaceuticals, which impacts the company’s financial performance and future prospects.
Presence Of Extreme Event: No
Nature Of Extreme Event: Other
Impact Rating Of The Extreme Event: Minor
Extreme Rating Justification: There is no extreme event mentioned in the article, and the situation described is a regulatory decision by the FDA regarding a drug application.
Move Size: No market move size mentioned.
Sector: Healthcare
Direction: Down
Magnitude: Large
Affected Instruments: Stocks

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