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.
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Vanda Pharmaceuticals Inc. (VNDA) achieved a significant legal victory in its jet lag FOIA litigation against the FDA. A federal court ruled in favor of Vanda on March 27, 2023, granting them access to records related to the FDA's review of Vanda's supplemental New Drug Application (sNDA) for Hetlioz® (tasimelteon). Despite the FDA's claims of potential harm from disclosure, the court determined that transparency is essential for scientific progress. This ruling emphasizes the need for the FDA to collaborate with drug innovators to foster advancements in public health.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced the appointment of Dr. Tage Honoré to its Board of Directors, effective March 15, 2023. His addition increases the board to six members, with five being independent. Dr. Honoré brings extensive experience from leadership roles at companies like Novo Nordisk and Novartis, as well as a strong background in scientific research, including over 100 peer-reviewed articles. Vanda's CEO, Mihael H. Polymeropoulos, expressed confidence in Dr. Honoré's ability to contribute to the company's innovative therapy development.
Vanda Pharmaceuticals reported Q4 2022 revenues of $64.5 million, marking a 5% decrease from Q4 2021. Full-year 2022 revenues totaled $254.4 million, also a 5% decline compared to 2021. HETLIOZ® sales decreased by 9% to $40.1 million due to reimbursement issues for Non-24-Hour Sleep-Wake Disorder, while Fanapt® saw a slight increase of 2% to $24.4 million. Net income for Q4 was $6.9 million, down from $7.1 million in Q4 2021. The company remains optimistic about pipeline advancements, including upcoming regulatory filings and ongoing clinical studies. However, uncertainties surrounding HETLIOZ® patent litigation hinder 2023 financial guidance.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) is set to release its fourth quarter and full year 2022 financial results on February 8, 2023, after market close. A conference call is scheduled for 4:30 PM ET on the same day, where management will discuss financial results and corporate activities. Interested parties can access the call by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 4734670. The call will also be archived on Vanda's website. A replay will be available from 8:30 PM ET on February 8 until 8:30 PM ET on February 15.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will participate in the J.P. Morgan Healthcare Conference in San Francisco on January 12, 2023. The corporate presentation is scheduled for 12:00 p.m. Pacific Time (3:00 p.m. Eastern Time) and will be accessible live on Vanda's corporate website. Investors are advised to log in early for registration and software setup. An archived link of the presentation will be available for 30 days post-event. Vanda focuses on developing innovative therapies to meet high unmet medical needs.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) reported positive results from a Phase III clinical study of Fanapt® (iloperidone tablets) for treating acute manic and mixed episodes in adults with bipolar I disorder. The trial, involving around 400 participants, demonstrated a significant improvement in mania symptoms compared to placebo, with a p-value of 0.000008. Notable outcomes included significant findings in Young Mania Rating Scale (YMRS) and other clinical measures. Vanda plans to submit a supplemental New Drug Application (sNDA) to the FDA in 2023 for this new indication.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced an update regarding its appeal in the HETLIOZ® ANDA litigation. The company appealed a ruling from December 13, 2022, by the United States District Court for Delaware to the Federal Circuit. A temporary injunction has been granted, preventing Teva Pharmaceuticals and Apotex from entering the market until at least January 6, 2023. Vanda seeks to extend this injunction while the appeal is considered, critical for protecting its HETLIOZ® market position.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced its response to a ruling in the HETLIOZ® ANDA Litigation. The court ruled that Teva and Apotex did not infringe on Vanda's patents related to HETLIOZ® (tasimelteon) and declared several of Vanda's patent claims invalid. Vanda plans to appeal the decision and will seek a stay on the market entry of Teva and Apotex during the appeal process. The litigation is limited to the U.S., and HETLIOZ® remains approved in the EU, unaffected by this ruling.