Tradipitant Gets FDA Green Light: What The Regulatory Win Means For VNDA Stock

2025-12-26 02:21:46

Vanda Pharmaceuticals’ (VNDA) motion sickness program just cleared a major hurdle. The U.S. Food and Drug Administration has withdrawn its partial clinical hold on the VP-VLY-686-3403 study protocol, removing restrictions that had capped treatment exposure at 90 doses.

The Regulatory Breakthrough Explained

Back in December 2018, the FDA imposed constraints on Tradipitant trials, questioning whether a six-month dog toxicity study was necessary given the indication being studied. The agency had required additional chronic safety data in animal models before Vanda could enroll patients in protocols exceeding 12 weeks.

The partial symbol of this previous concern—the extended toxicity requirement—has now disappeared. Here’s why: FDA reviewers accepted Vanda’s scientific argument that motion sickness represents an acute, self-resolving condition rather than a chronic or intermittent disorder requiring long-term safety surveillance. That distinction removed the justification for the additional animal study that was holding things up.

What Tradipitant Actually Is

This NK-1 receptor antagonist originated from Eli Lilly’s labs before Vanda licensed it for development. The company is pursuing multiple therapeutic applications: gastroparesis, motion sickness, and nausea triggered by GLP-1 receptor agonist use. The motion sickness indication represents the lead program, with an NDA currently under FDA review.

Timeline And Market Significance

The regulatory calendar matters here. December 30, 2025 marks the PDUFA target action date for the motion sickness NDA—potentially delivering the first novel pharmacological option for this condition in over 40 years.

CEO Mihael H. Polymeropoulos characterized the resolution as evidence of “effective collaborative engagement” with regulators, signaling smoother sailing ahead for the development pipeline.

Stock Action And Valuation Context

VNDA shares closed the prior session at $5.20 (down 1.33%), then climbed to $5.50 overnight—a 5.77% jump. The 12-month trading range spans $3.81 to $5.70, positioning current levels in the upper half of that band.

These observations reflect market activity and regulatory developments; they do not constitute investment advice or official positions of exchanges or trading platforms.

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