Vanda Pharmaceuticals Inc. 8-K

What Happened
Vanda Pharmaceuticals (VNDA) filed an 8-K on January 8, 2026 disclosing that following a collaborative framework announced October 1, 2025, the U.S. Food and Drug Administration completed an expedited re‑review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder and, on January 7, 2026, informed Vanda that the sNDA “cannot be approved in its current form.” Vanda issued a press release on January 8, 2026; that press release is attached to the filing as Exhibit 99.1.

Key Details

• FDA re‑review commitment announced in a collaborative framework was made public on October 1, 2025.
• FDA completed the expedited re‑review and delivered its conclusion on January 7, 2026.
• The FDA concluded the sNDA for HETLIOZ for jet lag disorder “cannot be approved in its current form.”
• Vanda filed the 8-K and attached its January 8, 2026 press release as Exhibit 99.1.

Why It Matters
This 8-K reports a regulatory decision directly affecting Vanda’s ongoing approval process for HETLIOZ in jet lag disorder. The FDA’s determination that the sNDA cannot be approved in its current form is a material development for investors because it affects the regulatory path and timing associated with that indication. Investors should monitor Vanda’s next communications for details on the FDA’s reasons and any planned company response or additional data submissions.