Welcome to our dedicated page for Vanda Pharmaceuticals news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharmaceuticals stock.
Vanda Pharmaceuticals Inc., traded under the symbol VNDA on Nasdaq, is a specialty biopharmaceutical company dedicated to the development and commercialization of innovative therapies. Vanda's primary focus is on addressing high unmet medical needs to improve the lives of patients. The company's commercial portfolio includes HETLIOZ for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome, and Fanapt for schizophrenia. Recently added to its portfolio is PONVORY, a treatment for multiple sclerosis.
Other promising products in Vanda's pipeline include VHX-896, ASO Molecules, VQW-765, Tradipitant (in clinical studies for gastroparesis and motion sickness), and VTR-297. Vanda's robust R&D efforts are highlighted by substantial advancements, such as the initiation of clinical programs in conditions like depression, psoriasis, ulcerative colitis, and pediatric insomnia.
In recent financial news, Vanda reported a net loss of $4.1 million for Q1 2024, a shift from a net income of $3.3 million in Q1 2023. Despite this, the company maintains a strong cash position and expects significant growth from upcoming milestones, including the launch of Fanapt in acute bipolar I disorder and PONVORY in multiple sclerosis.
Recently, Vanda made headlines with the FDA approval of tradipitant for preventing vomiting induced by motion sickness, and the commencement of a comprehensive marketing program for PONVORY following its acquisition from a Johnson & Johnson company. Additional corporate activities involve evaluating unsolicited acquisition proposals, indicating a strategic interest in Vanda’s innovative portfolio.
For more detailed information, investors can visit www.vandapharma.com and follow Vanda on social media platforms.
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.
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