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 U.S. commercial availability of NEREUS™ (tradipitant) on May 4, 2026 for the prevention of vomiting induced by motion in adults. The FDA approved NEREUS on December 30, 2025 after two Phase 3 trials conducted at sea. NEREUS is available by prescription via retail pharmacies and a direct-to-consumer portal at nereus.us, priced at a cash-pay $85 per dose through the portal versus a $255 list price per dose. Dosing is one or two capsules about an hour before travel.
Vanda (Nasdaq: VNDA) announced U.S. commercial availability of NEREUS™ (tradipitant) on May 1, 2026, for prevention of vomiting induced by motion in adults. The FDA approved NEREUS™ on December 30, 2025. NEREUS™ is an oral NK-1 receptor antagonist and is available by prescription via retail pharmacies and a direct-to-consumer portal at nereus.us.
The company lists a cash-pay price of $85 per dose through the portal versus a $255 standard list price.
Vanda Pharmaceuticals (Nasdaq: VNDA) will release first quarter 2026 financial results on Wednesday, May 6, 2026 after market close. A conference call and simultaneous webcast will be held at 4:30 PM ET the same day to discuss the results and corporate activities.
Investors should register on Vanda's website at least 15 minutes early; a replay will be available from 8:30 PM ET on May 6, 2026 through 11:59 PM ET on May 13, 2026.
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.