Welcome to our dedicated page for Vanda Pharmaceuticals news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharmaceuticals stock.
Vanda Pharmaceuticals Inc. develops and commercializes biopharmaceutical therapies, with company updates centered on prescription products and clinical or regulatory programs. Recurring news includes financial results, Fanapt sales trends, HETLIOZ commercialization, the U.S. availability of NEREUS (tradipitant) for prevention of vomiting induced by motion, and FDA approval of BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia.
Vanda news also covers development activity for imsidolimab in generalized pustular psoriasis, product-access and commercial-channel updates, investor conference participation, regulatory-policy statements, and corporate governance changes such as board appointments.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced the FDA granted a formal evidentiary public hearing under 21 CFR Part 12 to review CDER's proposed refusal of the company's sNDA for HETLIOZ® in jet lag disorder.
The FDA letter is dated March 2, 2026; the hearing follows a D.C. Circuit ruling that set aside the agency's earlier refusal in August 2025 and remanded the matter for resolution or hearing.
Vanda Pharmaceuticals (Nasdaq: VNDA) will participate in the 2026 Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026. A corporate presentation is scheduled for 2:15 p.m. Eastern Time and will be accessible live via Vanda's website under the Investors tab.
Investors are advised to register at the conference site at least 15 minutes early to download required software; an archived link will be available on Vanda's site for approximately 30 days.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced FDA acceptance of its Biologics License Application for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.
Pivotal GEMINI-1/2 studies showed 53% achieving GPPPGA 0/1 at Week 4 versus 13% placebo; efficacy maintained during ~2-year monthly maintenance, with a favorable safety profile and low anti-drug antibodies.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced FDA approval of BYSANTI™ (milsaperidone) for acute treatment of manic or mixed episodes in bipolar I disorder and for schizophrenia in adults. BYSANTI™ is a new chemical entity shown to be bioequivalent to iloperidone and aligns with iloperidone's safety profile.
Vanda expects commercial availability in Q3 2026, ongoing adjunctive trials in treatment‑resistant major depressive disorder due to complete by year‑end, and patent protection through 2044.
Vanda Pharmaceuticals (NASDAQ: VNDA) reported full year 2025 results, with Fanapt net product sales +24% to $117.3M and total revenues of $216.1M. The FDA approved NEREUS (tradipitant) for motion-induced vomiting; Bysanti (milsaperidone) NDA review has a PDUFA date of Feb 21, 2026. The company recorded a one-time, non-cash $113.7M valuation allowance against deferred tax assets, contributing to a 2025 net loss of $220.5M. Cash totaled $263.8M as of Dec 31, 2025. 2026 revenue guidance for marketed products is $230–$260M.
Vanda Pharmaceuticals (Nasdaq: VNDA) will announce fourth quarter and full year 2025 financial results on Wednesday, February 11, 2026 after market close. Management will host a conference call at 4:30 PM ET the same day and a simultaneous webcast will be available and archived on the company website.
Investors should register on the website at least 15 minutes early. Call-in numbers use passcode 8728050. A replay will be available beginning Feb 11, 2026 at 8:30 PM ET through Feb 18, 2026 at 11:59 PM ET with listed replay numbers.
Vanda Pharmaceuticals (Nasdaq: VNDA) said the FDA's CDER issued a decision letter on Jan 8, 2026 concluding the sNDA for HETLIOZ (tasimelteon) for jet lag disorder "cannot be approved in its current form."
The FDA acknowledged positive efficacy signals from Vanda's controlled trials but found phase advance protocols (5-hour and 8-hour bedtime shifts) insufficiently analogous to real-world jet travel. Vanda disagrees, cites simulated and actual transatlantic travel data and a >10-year safety record, and notes the D.C. Circuit set aside a prior FDA refusal in Aug 2025. Vanda said it will continue to engage the FDA and pursue avenues to advance approval.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced FDA approval of NEREUS™ (tradipitant) for the prevention of vomiting induced by motion on Dec 30, 2025. The approval is the first new pharmacologic motion‑sickness treatment in over 40 years and is supported by three pivotal trials. In Motion Syros (n=365) vomiting was 18.3–19.5% with NEREUS™ vs 44.3% placebo (p<0.0001); in Motion Serifos (n=316) vomiting was 10.4–18.3% vs 37.7% placebo (p≤0.0014), showing >50–70% risk reductions. NEREUS™ showed consistent vomiting reductions and a favorable acute safety profile. Vanda expects to launch NEREUS™ "in the coming months" and plans further development in gastroparesis and GLP‑1 agonist–induced nausea/vomiting.
Vanda Pharmaceuticals (Nasdaq: VNDA) submitted a Biologics License Application (BLA) to the FDA on Dec 15, 2025 for imsidolimab to treat generalized pustular psoriasis (GPP).
The BLA is supported by positive global Phase 3 GEMINI-1 and GEMINI-2 results: a single intravenous dose produced rapid clearance (clear or almost clear skin) with efficacy maintained during an approximately 2-year maintenance period with monthly dosing, and a favorable safety profile with no clinically meaningful safety signals reported. Vanda requested priority review, which could enable FDA action as early as mid-2026 if granted.
Vanda Pharmaceuticals (Nasdaq: VNDA) will participate in the J.P. Morgan Healthcare Conference in San Francisco on January 15, 2026. A corporate presentation is scheduled for 9:00 a.m. PT / 12:00 p.m. ET. The presentation will be accessible live via Vanda's website under the Investors > Recent Events section.
Investors are advised to visit the conference website at least 15 minutes early to register and install any required software. A link to the archived presentation will be available on Vanda's website for approximately 30 days after the event.