Vanda Pharma Stock Price, News & Analysis

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.

Vanda Pharmaceuticals (Nasdaq: VNDA) announced results from a Phase II clinical study of VQW-765, a novel alpha 7 nicotinic acetylcholine receptor partial agonist, aimed at treating acute performance anxiety. In the study with 230 participants, VQW-765 demonstrated lower stress levels compared to placebo, particularly among female participants, who experienced significant effects. This study marks the first evidence of an α7-nAChR agonist's efficacy for performance anxiety. The drug's side effect profile resembled that of placebo, supporting its potential as a treatment option.

Vanda Pharmaceuticals Inc. (VNDA) announced its participation in upcoming investor conferences in November 2022. The company will present at the Stifel 2022 Healthcare Conference on November 15 at 10:20 a.m. Eastern Time, and at the Jefferies 2022 London Healthcare Conference on November 17 at 12:20 p.m. Greenwich Mean Time (7:20 a.m. Eastern Time). Live access to these presentations will be available on Vanda's corporate website, with archived versions accessible for about 30 days.