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U.S. FDA declines to approve Vanda's stomach paralysis drug
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U.S. FDA declines to approve Vanda's stomach paralysis drug
Sep 25, 2024 8:32 PM

(Reuters) - The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' ( VNDA ) drug to treat stomach paralysis symptoms, the company said on Thursday.

Shares of the company fell about 14% to $4.26 in premarket trading.

Vanda was seeking the health regulator's nod for the drug tradipitant to treat gastroparesis, a condition characterized by delayed gastric emptying.

The disease is associated with symptoms such as severe nausea, vomiting, and difficulty finishing a normal meal.

Vanda licensed tradipitant from Eli Lilly ( LLY ) and is also studying it for motion sickness.

The health regulator had imposed a partial clinical hold on tradipitant, preventing trials longer than 12 weeks.

The company plans to submit a separate application for the drug to prevent vomiting in motion sickness later this year.

(Reporting by Sriparna Roy in Bengaluru; Editing by Abinaya Vijayaraghavan)

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