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) 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.
Vanda Pharmaceuticals (Nasdaq: VNDA) will participate in the Stifel 2025 Healthcare Conference in New York City on Wednesday, November 12, 2025.
A corporate presentation is scheduled for 4:40 p.m. Eastern Time and will be accessible live on Vanda's investor website via the Investors tab under Recent Events. Attendees are advised to arrive at the conference website at least 15 minutes early to register and download any required software or materials. Archived conference links will be available on Vanda's website for approximately 30 days after the event.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported Q3 2025 results with total net product sales of $56.3M, up 18% year-over-year, led by Fanapt sales of $31.2M (+31%) and HETLIOZ sales of $18.0M.
The company reported a Q3 net loss of $22.6M and cash of $293.8M as of September 30, 2025. Vanda updated 2025 guidance, lowering full-year revenue range to $210–$230M and year-end cash to $260–$290M.
Key regulatory milestones: tradipitant PDUFA 12/30/2025, Bysanti PDUFA 2/21/2026, expedited FDA re-review of HETLIOZ sNDA by 1/7/2026, and anticipated imsidolimab BLA submission in Q4 2025.
Vanda Pharmaceuticals (Nasdaq: VNDA) will release its third quarter 2025 financial results on Wednesday, October 29, 2025 after market close.
The company will host a conference call at 4:30 PM ET on October 29, 2025 to discuss the results and corporate activities; domestic dial-in is 1-888-596-4144, international 1-646-968-2525, passcode 8728050. A simultaneous webcast will be available and archived on www.vandapharma.com; investors should access the site at least 15 minutes early to register and install audio software.
A replay will be available beginning October 29, 2025 at 8:30 PM ET through November 5, 2025 at 11:59 PM ET; replay domestic number 1-800-770-2030, international 1-609-800-9909, passcode 8728050.
Vanda Pharmaceuticals (Nasdaq: VNDA) signed a multi-year Founding Partner agreement with Monumental Sports & Entertainment on Oct 8, 2025 to become a marquee sponsor of the next-generation downtown arena and receive exclusive entitlement of the Vanda Pharmaceuticals Studio on Monumental Sports Network (MNMT).
The deal includes branding across the Washington Wizards, Capitals, and Mystics, integrated in-game and digital activations, visibility across the Capital One Arena transformation, and community programming. The studio opened in March 2024 and features 24 cameras and 1,200 sq ft of 4K LED displays. The arena welcomes about 3 million guests annually.
Vanda Pharmaceuticals (Nasdaq: VNDA) has reached a collaborative framework with the FDA to resolve multiple regulatory disputes regarding HETLIOZ® and tradipitant. The agreement includes expedited reviews of several key applications: the partial clinical hold on tradipitant for motion sickness by November 26, 2025, the NDA review with a PDUFA date of December 30, 2025, and the sNDA for HETLIOZ® for jet lag disorder by January 7, 2026.
As part of the agreement, Vanda will dismiss multiple lawsuits against the FDA, including challenges to the clinical hold on tradipitant and HETLIOZ® efficacy information sharing. The framework also includes temporary pauses in various administrative proceedings and legal actions to facilitate the resolution process.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced the publication of positive clinical trial results for HETLIOZ® in treating primary insomnia in PLOS One journal. The study demonstrated significant improvements in sleep latency, with patients showing mean improvements of 44.9 minutes (20mg dose) and 46.3 minutes (50mg dose) compared to 28.2 minutes for placebo (p < 0.001).
The improvements persisted through follow-up periods (Nights 22 and 29), and importantly, no cognitive or mood changes, rebound, or withdrawal effects were observed after discontinuation. HETLIOZ®, a melatonin receptor agonist, is currently pursuing FDA approval for insomnia and Jet Lag Disorder treatment, while also developing applications for other sleep disorders.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced its participation in three major healthcare investor conferences in September 2025. The company will present at the Cantor Global Healthcare Conference in New York on September 3 at 3:55 PM ET, the Wells Fargo Healthcare Conference in Boston on September 4 at 4:30 PM ET, and the H.C. Wainwright Annual Global Investment Conference in New York on September 9 at 8:30 AM ET.
All presentations will be accessible through live webcasts on Vanda's corporate website, with archived versions available for approximately 30 days following the events.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that its novel drug candidate VGT-1849B has received FDA Orphan Drug Designation for the treatment of polycythemia vera (PV), a rare blood disorder affecting 44-57 per 100,000 people in the US.
VGT-1849B is a selective peptide nucleic acid-based JAK2 inhibitor that specifically targets JAK2 mRNA, distinguishing itself from existing treatments like Jakafi®, Inrebic®, Ojjaara®, and Vonjo® which are not JAK2-selective. The drug's unique OPNA backbone chemistry enhances cell permeability and RNA affinity, potentially offering improved safety and less frequent dosing compared to current treatments.