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 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.
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