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) 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.
Vanda Pharmaceuticals (Nasdaq: VNDA) has requested FDA Commissioner Martin Makary to review a recent decision regarding generic versions of Hetlioz®. The review petition follows outgoing CDER Director Jacqueline Corrigan-Curay's decision to uphold the approval of two generic versions of the drug, despite Vanda's 2023 citizen petitions challenging these approvals.
The controversy centers on bioequivalence studies that Vanda claims are flawed, specifically noting that the studies were conducted only on Indian male subjects and showed concerning data inconsistencies, including exposure levels more than double those of Hetlioz®. Vanda argues this reflects an institutional bias toward approving generic drugs regardless of evidence standards.
Vanda Pharmaceuticals (Nasdaq: VNDA) has achieved a significant legal victory against the FDA in its pursuit to get HETLIOZ® (tasimelteon) approved for treating jet lag disorder. The U.S. Court of Appeals for the D.C. Circuit has overturned the FDA's denial of Vanda's supplemental New Drug Application (sNDA), which was originally submitted in October 2018.
The Court ruled that the FDA failed to properly consider Vanda's evidence, noting that the company provided "specific, reasoned, and rooted in evidence" expert views. Clinical trials demonstrated statistically significant improvement in primary endpoints for treating sleep disturbance. The case has been remanded to the FDA, which must now either approve the sNDA or grant Vanda a hearing.
This landmark decision sets a precedent requiring the FDA to meaningfully engage with evidence presented by drug innovators, potentially transforming the regulatory landscape for pharmaceutical companies.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported Q2 2025 financial results, with total net product sales reaching $52.6 million, a 4% increase year-over-year. Fanapt® showed strong performance with net sales of $29.3 million, up 27% YoY, while HETLIOZ® and PONVORY® sales declined. The company reported a net loss of $27.2 million for Q2 2025.
Key regulatory milestones include Bysanti™ NDA acceptance for bipolar I disorder and schizophrenia (PDUFA date: February 21, 2026), Tradipitant NDA for motion sickness (PDUFA date: December 30, 2025), and planned Imsidolimab BLA submission for GPP in 2025. The company maintains its 2025 guidance of $210-250 million in total revenues.
Vanda Pharmaceuticals (Nasdaq: VNDA) has scheduled its second quarter 2025 financial results announcement for July 31, 2025, before market opening. The company will host a conference call at 8:00 AM ET on the same day to discuss the quarterly results and corporate activities.
Investors can participate by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 9430387. The call will be simultaneously webcast on www.vandapharma.com. A replay will be available from 11:00 AM ET until August 7, 2025, at 11:59 PM ET.