Vanda's HETLIOZ Hits Phase 3 Endpoint in Sleep Disorder; VNDA Jumps 10% After Hours

Vanda Pharmaceuticals Inc. (VNDA) reported positive topline Phase 3 results for HETLIOZ (tasimelteon) in adults with Delayed Sleep-Wake Phase Disorder on Sept. 30, 2026, sending shares up 10.14% to $5.54 in overnight trading after closing at $5.03. The 28-day, double-blind, placebo-controlled trial met its primary endpoint: patients on once-daily oral HETLIOZ 20 mg shifted sleep onset 42.5 minutes earlier versus 5.4 minutes for placebo, a 37.1-minute treatment difference. Sixty percent of treated patients achieved a shift of at least 30 minutes, compared with 15% on placebo. HETLIOZ, approved in 2014 for Non-24-Hour Sleep-Wake Disorder and in 2020 for Smith-Magenis Syndrome sleep disturbances, would become the first FDA-approved therapy specifically for DSWPD. Vanda plans to meet with the FDA and file a supplemental New Drug Application. The drug posted $5.6 million in second-quarter 2026 net sales, down 66% year over year, partly on shipment timing, with about $7.0 million expected in the third quarter. VNDA has traded between $4.27 and $9.94 over the past year.