Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis
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Vanda Pharmaceuticals has accepted an FDA opportunity for a hearing regarding its New Drug Application for Tradipitant, a treatment for gastroparesis. The company highlights issues with the FDA's review process.
January 27, 2025 | 12:15 pm
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Vanda Pharmaceuticals is set to have a hearing with the FDA concerning its drug Tradipitant for gastroparesis, pointing out flaws in the FDA's review process.
The news indicates a regulatory development for Vanda Pharmaceuticals, as they are engaging with the FDA over their drug application. While this could lead to positive outcomes if the hearing is successful, the uncertainty of the process and the highlighted review issues suggest a neutral short-term impact on the stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100