Vanda Pharmaceuticals Says FDA Will Take More Time To Decide On Tradipitant Clinical Hold Re-Review

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The FDA was initially expected to complete the re-review on November 26 and has since then extended it to December 5.

  • The postponement was to accommodate the leadership shift at the Center for Drug Evaluation and Research, the company said. 
  • Vanda continues to expect the agency to decide on its application seeking approval for Tradipitant for the prevention of vomiting induced by motion by December 30. 
  • The company said it has commenced discussions on the drug’s proposed labeling.

Vanda Pharmaceuticals Inc. (VNDA) said on Friday that the U.S. Food and Drug Administration (FDA)’s re-review of the clinical hold on long-term clinical studies of Tradipitant in motion sickness has been extended.

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The FDA was initially expected to complete the re-review on November 26 and has since then extended it to December 5 to accommodate the leadership shift at the Center for Drug Evaluation and Research, the company said.

Fresh Dates

Vanda expects the agency to decide on its application seeking approval for Tradipitant for the prevention of vomiting induced by motion by December 30, according to previous schedule.

The company said it has commenced discussions on the drug’s proposed labeling.

Vanda licensed Tradipitant from American drugmaker Eli Lilly and Company. It is being developed for multiple conditions, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.

Earlier this month, the company announced that Tradipitan reduced nausea and vomiting induced by GLP-1 drug Wegovy in overweight and obese adults by about 50%. The company is looking forward to a late-stage trial for the condition in the first half of 2026.

How Did Stocktwits Users React?

Shares of VNDA traded 3% higher on Friday morning. On Stocktwits, retail sentiment around VNDA stock fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels.

A Stocktwits user highlighted that the company does not expect a delay in its drug application decision.

VNDA stock is up by 14% this year and by 6% over the past 12 months. 

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