VNDA Vanda Pharmaceuticals

Vanda Quimilza (imsidolimab) BLA PDUFA set for Dec 12, 2026

The BLA for Quimilza (imsidolimab) in GPP is under FDA review with a PDUFA target action date of December 12, 2026. This sets a decision date for the application following prior submission and acceptance.

Vanda reports positive Phase 3 topline for tradipitant (NEREUS) in GLP-1 induced vomiting

Study 3601 met its primary endpoint of reduced incidence of any vomiting (43.0% vs 58.5% placebo, p=0.006) and key secondary of vomiting plus severe nausea (33.1% vs 50.6%, p=0.002). Vanda plans to discuss results with FDA and submit an sNDA for prevention of vomiting associated with GLP-1 receptor agonists.

tradipitant · NCT06836557 registry update

status: RECRUITING → COMPLETED; primary_completion: 2025-12 → 2026-03-30; completion: 2025-12 → 2026-03-30; enrollment: 100 → 17

Vanda VQW-765 Phase 3 misses primary endpoint in social anxiety disorder

The Phase 3 study of VQW-765 in adults with social anxiety disorder did not meet its primary endpoint. VQW-765 was safe and well tolerated, consistent with prior studies.

tasimelteon · NCT04652882 registry update

status: ACTIVE_NOT_RECRUITING → COMPLETED; primary_completion: 2026-09 → 2026-09-04; completion: 2026-09 → 2026-09-04; enrollment: 70 → 43

Vanda to present imsidolimab GPP data at 2026 EADV Annual Meeting

Vanda will present three posters on imsidolimab in GPP at the EADV 2026 meeting, covering neutrophil reduction, immunogenicity, and pustulation improvement from the GEMINI-1 study. This is a scientific conference presentation with no direct impact on the regulatory path.

Vanda HETLIOZ (tasimelteon) Phase 3 Meets Primary Endpoint in Delayed Sleep-Wake Phase Disorder

Vanda reported positive Phase 3 topline results for HETLIOZ (tasimelteon) in Delayed Sleep-Wake Phase Disorder. The study met its primary endpoint with a 37.1-minute earlier sleep onset versus placebo (p=0.022). 60% of treated patients shifted sleep by at least 30 minutes versus 15% on placebo.

imsidolimab · NCT06830044 registry update

countries: {'total_sites': 38, 'us_sites': 21} → {'total_sites': 53, 'us_sites': 29}

tradipitant · NCT04028492 registry update

enrollment: 992 → 979; primary_outcomes: ['Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)'] → ['Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population']

Vanda: Quimilza (imsidolimab) BLA PDUFA set for Dec 12 2026

FDA set a PDUFA target action date of December 12, 2026 for the Quimilza BLA in GPP. The application is under active review and topline data from the pivotal study were published in NEJM Evidence.

Vanda: EMA positive opinion for imsidolimab orphan designation in GPP

EMA's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug designation for imsidolimab in generalized pustular psoriasis. This is the first such designation for any GPP therapy in the EU, granting protocol assistance, reduced fees, and future market exclusivity. The designation follows similar recognitions in the US and Japan; the FDA BLA remains under review with a December 12, 2026 target action date.

Anaptys: Vanda imsidolimab PDUFA set for Dec 12 2026 in GPP

The press release states that the FDA has assigned a target action date of December 12, 2026 for the imsidolimab BLA in generalized pustular psoriasis. This is the only future regulatory milestone explicitly dated in the document.

Vanda: imsidolimab BLA for GPP has PDUFA date of Dec 12, 2026

The BLA for imsidolimab in Generalized Pustular Psoriasis has been submitted to FDA and assigned a target action date of December 12, 2026. Phase 3 efficacy and safety data have been published in NEJM Evidence and are included in the application. Vanda holds an exclusive global license from AnaptysBio.

Vanda initiates Thetis Phase 2 trial of tradipitant for GLP-1 vomiting

Vanda has started Thetis, a multicenter Phase 2 trial testing oral tradipitant to prevent vomiting in patients starting high-dose GLP-1 agonists. The study is randomized, double-blind, placebo-controlled with a primary endpoint of vomiting-free patients. Topline results are expected in Q4 2026, after which additional data may be needed before an NDA submission.

AnaptysBio, Inc. · FDA approves Bysanti (milsaperidone)

FDA lists Bysanti (milsaperidone) as novel drug approval #3 of 2026 on 2026-02-20: To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder

VNDA: Bysanti NDA PDUFA set for February 21, 2026

FDA accepted the Bysanti (milsaperidone) NDA for bipolar I disorder and schizophrenia and assigned a PDUFA target action date of February 21, 2026. The decision will determine whether the company can expand its psychiatry franchise with a second antipsychotic product.

Vanda Receives FDA Decision Letter on HETLIOZ sNDA for Jet Lag Disorder

FDA issued a decision letter concluding the sNDA for tasimelteon in jet lag disorder cannot be approved in its current form, citing that phase-advance trial data do not constitute substantial evidence of effectiveness. Vanda disagrees and notes the letter follows a D.C. Circuit remand and an October 2025 collaborative re-review framework.

Tradipitant NDA for motion sickness has PDUFA date of Dec 30, 2025

The tradipitant NDA for motion sickness is under FDA review with a PDUFA target action date of December 30, 2025. The Bysanti NDA for bipolar I disorder and schizophrenia is also under review with a PDUFA date of February 21, 2026. The imsidolimab BLA for generalized pustular psoriasis is expected to be submitted in Q4 2025.