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Vanda Q3 sales rise 24% to $69.8M as FDA decisions loom

🇺🇸 Vanda Pharmaceuticals Inc. (VNDA) · Wed 28 Oct 2026

Vanda Pharmaceuticals reports higher third-quarter product sales and lower spending, while flagging planned sNDA filings, a BYSANTI launch and two FDA milestones in December.

Vanda Pharmaceuticals reported net product sales of $69.8 million for the third quarter of 2026, a 24% increase on the same period a year earlier. The results were dated 28 October 2026. Operating expenses fell 18% from the second quarter to $93.3 million.

The company said Phase III results for NEREUS (tradipitant) in GLP-1-induced vomiting, together with HETLIOZ results in Delayed Sleep-Wake Phase Disorder, will lead to planned supplemental new drug application (sNDA) submissions. No filing dates were given in the information available.

Vanda also set out several regulatory and commercial milestones for the coming weeks. BYSANTI is expected to launch in the fourth quarter of 2026. The biologics licence application (BLA) for Quimilza in generalised pustular psoriasis has a PDUFA goal date of 12 December 2026.

An FDA hearing on HETLIOZ for jet lag disorder is scheduled for 14 to 18 December 2026. A PDUFA date is the target by which the FDA aims to complete its review of an application, though it does not guarantee approval.

What it means for your team

  • Regulatory teams tracking Vanda should note the 12 December 2026 PDUFA date for Quimilza and the 14-18 December FDA hearing on HETLIOZ in jet lag disorder.
  • Planned sNDAs for NEREUS in GLP-1-induced vomiting and HETLIOZ in Delayed Sleep-Wake Phase Disorder point to label-expansion filings, though submission timing has not been disclosed.
  • Market-access and pharmacovigilance teams should expect a BYSANTI launch in Q4 2026, with launch-related monitoring and payer activity to follow.

Company's press release (SEC filing): Vanda Pharmaceuticals Inc. ↗

Article written by VigiEye from the official source (Vanda Pharmaceuticals Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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