Welcome to our dedicated page for Vanda Pharma news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharma 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 (ANAB) announced publication of a peer‑reviewed NEJM Evidence article reporting the pivotal phase III study of imsidolimab for Generalized Pustular Psoriasis (GPP).
The study findings are included in a Biologics License Application (BLA) for imsidolimab submitted to the U.S. FDA, with a target action date of December 12, 2026.
Vanda Pharmaceuticals (Nasdaq: VNDA) appointed Charles Duncan, Ph.D., to its Board effective April 22, 2026. The board now has seven directors, six independent. Dr. Duncan brings ~30 years of biotechnology equity research experience and founded Sulci Advisors in September 2025. Recent company milestones cited include approvals of NEREUS and BYSANTI, prior Fanapt label expansion, and a pipeline with expected data over the next ~12 months.
Vanda Pharmaceuticals (NASDAQ: VNDA) on April 9, 2026 urged FDA Commissioner Dr. Marty Makary to withdraw a FY 2027 proposal that would remove the 180‑day NDA statutory review requirement and replace it with longer PDUFA/GDUFA performance goals.
The company says the change would extend total review times to 10–12 months, eliminate formal evidentiary hearings, and roll back a recent court-ordered hearing Vanda won after more than 40 years.
Vanda Pharmaceuticals (Nasdaq: VNDA) initiated Thetis, a multicenter, randomized, double-blind Phase 2 trial of NEREUS™ (tradipitant) to prevent vomiting in patients started on high-dose GLP-1 receptor agonists. The company expects topline results by Q4 2026.
Prior Phase 2 data showed vomiting in 29.3% of tradipitant-treated participants versus 58.6% on placebo (p=0.0016), a 50% relative reduction; a key secondary endpoint also favored tradipitant (22.4% vs 48.3%, p=0.0039).
Vanda Pharmaceuticals (Nasdaq: VNDA) criticized the FDA's March 18, 2026 draft guidance on New Approach Methodologies (NAMs), arguing it lacks concrete examples, validation criteria, and citations needed to replace animal tests.
Vanda called for withdrawal and substantial revision, urging clear acceptance pathways, specific validated NAM examples, and collaboration with industry and animal welfare groups.
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.