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Vanda reports positive Phase III results for HETLIOZ in sleep disorder

Tue, 29 Sep 2026 19:10:09 -0400

Vanda Pharmaceuticals (NASDAQ: VNDA) announced positive topline results from a Phase III study of HETLIOZ (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD), according to a company statement on Tuesday.

The multicenter, double-blind, randomized, placebo-controlled study enrolled 43 patients with DSWPD across 26 clinical sites in the U.S. and Europe over five years. Patients received once-daily oral tasimelteon 20 mg or a matching placebo for 28 days.

The study met its primary endpoint. Patients taking HETLIOZ shifted their sleep onset 42.5 minutes earlier on average, compared with 5.4 minutes for those on placebo — a statistically significant 37.1-minute

Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder

Tue, 29 Sep 2026 18:45:00 -0400

Study met its primary endpoint: timing of sleep onset shifted 37.1 minutes earlier versus placebo (p=0.022)
60% of HETLIOZ^® treated participants shifted sleep at least 30 minutes earlier, compared to 15% of the placebo arm

Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder

Tue, 29 Sep 2026 18:45:00 -0400

Study met its primary endpoint: timing of sleep onset shifted 37.1 minutes earlier versus placebo (p=0.022)
60% of HETLIOZ^® treated participants shifted sleep at least 30 minutes earlier, compared to 15% of the placebo arm

Oppenheimer Starts Vanda Pharmaceuticals (VNDA) at Outperform

Wed, 23 Sep 2026 06:10:34 -0400

(Updated - September 23, 2026 6:10 AM EDT)

Oppenheimer initiates coverage on Vanda Pharmaceuticals (NASDAQ: VNDA) with a Outperform rating and a price target of $10.00.

The analyst comments "We initiate coverage of Vanda Pharmaceuticals with an Outperform rating, as we believe the market underappreciates the company’s transition from a three-product commercial business into a diversified specialty pharma platform. Fanapt is benefiting from strong bipolar I disorder adoption, while Bysanti supports a transition toward improved Medicaid economics and extends the psychiatry franchise’s IP runway into 2044. Nereus and potential Quimilza approval add commercial growth drivers, with several Ph3 readouts providing additional pipeline

Oppenheimer Starts Vanda Pharmaceuticals (VNDA) at Outperform

Wed, 23 Sep 2026 06:10:34 -0400

(Updated - September 23, 2026 6:10 AM EDT)

Oppenheimer initiates coverage on Vanda Pharmaceuticals (NASDAQ: VNDA) with a Outperform rating and a price target of $10.00.

EU grants Vanda's imsidolimab first orphan status for rare skin disease

Mon, 24 Aug 2026 07:04:39 -0400

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the European Commission has granted Orphan Designation to its investigational drug imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), a rare inflammatory skin disease.

According to the company's press release, this marks the first time the European Commission has granted orphan designation for a drug targeting GPP in the European Union. The designation followed a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products.

GPP is characterized by widespread pustular eruptions, systemic inflammation, and complications that can lead to increased mortality. Imsidolimab inhibits IL-36 receptor signaling, which is implicated in the

EU grants Vanda's imsidolimab first orphan status for rare skin disease

Mon, 24 Aug 2026 07:04:39 -0400

Vanda Pharmaceuticals Granted Orphan Designation for Imsidolimab for the Treatment of Generalized Pustular Psoriasis by the European Commission