Home/Filings/8-K/0001628280-25-059155
8-K//Current report

Vanda Pharmaceuticals Inc. 8-K

Accession 0001628280-25-059155

$VNDACIK 0001347178operating

Filed

Dec 30, 7:00 PM ET

Accepted

Dec 30, 6:45 PM ET

Size

251.9 KB

Accession

0001628280-25-059155

Research Summary

AI-generated summary of this filing

Updated

Vanda Pharmaceuticals Announces FDA Approval of NEREUS for Motion Sickness

What Happened

  • Vanda Pharmaceuticals Inc. announced on December 30, 2025 (via Form 8‑K, Item 8.01) that the U.S. Food and Drug Administration has approved NEREUS (tradipitant) for the prevention of vomiting induced by motion. The company attached a press release dated December 30, 2025 as Exhibit 99.1 to the filing.

Key Details

  • Filing date: December 30, 2025 (Form 8‑K, Item 8.01 and Item 9.01).
  • Product approved: NEREUS (tradipitant) for prevention of vomiting induced by motion.
  • Disclosure: Company press release is included as Exhibit 99.1 and incorporated by reference.
  • Form 8‑K signed by Timothy Williams, Senior Vice President, General Counsel and Secretary.

Why It Matters

  • FDA approval is a key regulatory milestone that authorizes Vanda to market NEREUS in the U.S. for the specified indication (prevention of motion‑induced vomiting).
  • For investors, the approval is material news about the company’s product pipeline and commercialization potential; the 8‑K provides the official announcement and the company’s public disclosure of the event.