FDA Strikes Off Vanda Pharmaceuticals' Tradipitant For Stomach Paralysis, Asks For Additional Studies
Portfolio Pulse from Vandana Singh
The FDA has declined Vanda Pharmaceuticals' NDA for tradipitant, a treatment for gastroparesis, citing the need for additional studies. The FDA's decision was delayed and did not meet legal requirements. Vanda plans to continue pursuing approval and will submit a separate NDA for motion sickness.
September 19, 2024 | 2:33 pm
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NEGATIVE IMPACT
Vanda Pharmaceuticals' NDA for tradipitant was declined by the FDA, leading to a 7.68% drop in stock price. The FDA requested additional studies, delaying the approval process.
The FDA's decision to decline the NDA for tradipitant directly impacts Vanda Pharmaceuticals, as it delays the potential market entry of the drug. The stock price dropped by 7.68% following the news, indicating a negative market reaction. The requirement for additional studies suggests a prolonged timeline for potential approval, affecting investor sentiment.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100