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. (Nasdaq: VNDA) is a biopharmaceutical company whose news flow centers on FDA interactions, clinical trial results, product approvals, and financial performance. Recent press releases describe Vanda as a global biopharmaceutical company focused on therapies for high unmet medical needs, with commercial products including HETLIOZ, Fanapt, PONVORY, and NEREUS (tradipitant).
On this VNDA news page, readers can follow company announcements about regulatory milestones, such as FDA approvals, decision letters, and Biologics License Application or New Drug Application submissions. Examples include the FDA approval of NEREUS for the prevention of vomiting induced by motion, the submission of a BLA for imsidolimab in generalized pustular psoriasis, and updates on the collaborative framework with the FDA for HETLIOZ and tradipitant.
Investors and followers can also track clinical development updates, including topline data from randomized studies of tradipitant in GLP-1 agonist–induced nausea and vomiting, Phase 3 results in motion sickness, and long-term maintenance data for imsidolimab in generalized pustular psoriasis. Vanda’s news often highlights how these data support ongoing or planned regulatory submissions and potential new indications.
In addition, Vanda regularly issues financial and corporate communications, such as quarterly earnings releases, guidance updates, and notices of participation in investor conferences like the J.P. Morgan Healthcare Conference and the Stifel Healthcare Conference. These items provide context on product sales for Fanapt, HETLIOZ, and PONVORY, as well as commentary on commercial strategy and pipeline priorities.
By monitoring this VNDA news feed, readers can see how Vanda’s commercial performance, regulatory decisions, and clinical trial outcomes evolve over time across sleep-wake disorders, psychiatric illness, motion sickness, inflammatory skin disease, and treatment-related nausea and vomiting.
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.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that the FDA lifted a partial clinical hold on protocol VP-VLY-686-3403 effective Dec 4, 2025, removing a prior 90-dose limit on tradipitant dosing.
The agency agreed motion sickness is an acute, event-driven condition, eliminating the need for an additional six-month dog toxicity study and allowing Vanda to extend clinical studies of tradipitant. Separately, the company noted the New Drug Application for tradipitant to prevent motion-induced vomiting remains under review with a PDUFA target action date of Dec 30, 2025.
Vanda Pharmaceuticals (Nasdaq: VNDA) provided regulatory updates on tradipitant for motion sickness on November 28, 2025.
The FDA is conducting an expedited re-review of a partial clinical hold that limits long-term tradipitant studies; the target completion date was extended from November 26, 2025 to December 5, 2025 at the FDA's request to accommodate CDER personnel and leadership transitions. Separately, the New Drug Application (NDA) review remains on schedule with an unchanged PDUFA target action date of December 30, 2025. The FDA has issued labeling comments and formal labeling discussions with Vanda have begun.
Vanda said it looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported positive topline results from a randomized, double-blind study (VP-VLY-686-2601) testing oral tradipitant to prevent GLP-1 agonist–induced nausea and vomiting in overweight/obese adults given a 1 mg Wegovy® injection.
The trial (N=116) met its primary endpoint: vomiting occurred in 29.3% of tradipitant patients vs 58.6% placebo (p=0.0016), a ~50% relative reduction. A key secondary endpoint (vomiting plus significant nausea) was 22.4% vs 48.3% (p=0.0039). Tradipitant showed a favorable safety profile and Vanda plans a Phase III program anticipated to start in H1 2026.