Vanda Pharmaceuticals has received notification from the U.S. Food and Drug Administration indicating that additional time is required to complete the review of the partial clinical hold on long-term tradipitant studies. This regulatory development has resulted in the agency pushing back its target decision date from November 26 to December 5, 2025. The postponement stems from leadership transitions within the FDA’s Center for Drug Evaluation and Research.
Despite this recent scheduling adjustment, the overall timeline for the drug application remains unaffected. The Prescription Drug User Fee Act (PDUFA) target date of December 30, 2025, for the final regulatory decision continues unchanged. In a positive development, Vanda confirmed that formal product labeling discussions with the FDA have commenced—a procedural milestone typically occurring during advanced stages of the approval process.
Mixed Signals from Markets and Analysts
Trading activity on Friday revealed investor optimism regarding these regulatory updates, with Vanda shares climbing approximately 3% to reach $5.36. This upward movement propelled the stock price above its 200-day moving average of $4.69—a key technical indicator that market participants monitor to gauge long-term trend direction.
Should investors sell immediately? Or is it worth buying Vanda?
However, fundamental analysis presents a contrasting perspective. Financial data platform Wall Street Zen downgraded Vanda from “Hold” to “Sell” on Saturday, following the company’s disappointing quarterly earnings report. The pharmaceutical firm reported a loss of $0.38 per share, worse than the anticipated $0.31 loss, while revenue of $56.3 million fell short of the projected $58.7 million.
Key Developments at a Glance
- Clinical Hold Review: Rescheduled by FDA to December 5, 2025
- Approval Decision: PDUFA target date maintained at December 30, 2025
- Current Trading: Approximately $5.36, above 200-day moving average
- Analyst Rating: Downgraded to “Sell” by Wall Street Zen
December Presents Concentrated Regulatory Activity
The extended timeline for the clinical hold review creates a compressed schedule of significant December events for investors. Market participants now face two crucial December deadlines: the revised December 5 date for clarity on long-term studies, followed by the ultimate approval decision on December 30. While the initiation of labeling discussions suggests productive dialogue between the company and regulators, recent disappointing financial results and the analyst downgrade highlight persistent fundamental concerns.
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