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. (Nasdaq: VNDA) announced that the FDA has declined to approve its New Drug Application (NDA) for tradipitant, a treatment for gastroparesis symptoms. The FDA provided a Complete Response Letter (CRL) on September 18, 2024, 185 days after the submission deadline. Vanda argues that the FDA's action fails to meet the Food Drug and Cosmetic Act requirements and disregards the evidence provided, including two placebo-controlled studies and real-world patient experiences. Despite this setback, Vanda believes tradipitant meets the substantial evidence of efficacy standard and plans to continue pursuing marketing authorization. The company will also maintain its expanded access program for gastroparesis patients and plans to submit a separate NDA for tradipitant in motion sickness prevention later this year.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has announced its participation in the 2024 Cantor Global Healthcare Conference in New York City on September 19, 2024. The company is scheduled for a fireside chat at 8:00 a.m. Eastern Time. Investors can access the live chat on Vanda's corporate website under the Investors tab and Recent Events section.
Attendees are advised to arrive at the conference website 15 minutes early to register and set up any necessary software. The archived conference will be available on Vanda's website for approximately 30 days following the event.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has announced its participation in the H.C. Wainwright Global Investment Conference in New York City on September 10, 2024. The company is scheduled to give a corporate presentation at 2:00 p.m. Eastern Time. Investors can access the live presentation through Vanda's corporate website, www.vandapharma.com, by navigating to the Investors tab and following the link under Recent Events.
Attendees are advised to arrive at the conference website 15 minutes early to register and set up any necessary software. The archived presentation will be available on Vanda's website for approximately 30 days after the event.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has announced its participation in the Wells Fargo 2024 Healthcare Conference in Boston on September 6, 2024. The company's corporate presentation is scheduled for 11:00 a.m. Eastern Time. Investors can access the live presentation through Vanda's corporate website, www.vandapharma.com, by following the link under Recent Events in the Investors tab. It is recommended that investors arrive at the conference website 15 minutes early to register and set up any necessary software. The archived conference will be available on Vanda's website for approximately 30 days after the event.
Vanda Pharmaceuticals reported Q2 2024 financial results with total net product sales of $50.5 million, a 10% increase year-over-year. Key highlights include:
1. Fanapt® net sales of $23.2 million, down 4% YoY but up 12% QoQ
2. HETLIOZ® net sales of $18.7 million, down 15% YoY due to generic competition
3. PONVORY® net sales of $8.6 million, up 26% QoQ
4. Net loss of $4.5 million compared to net income of $1.5 million in Q2 2023
5. Cash position of $387.7 million as of June 30, 2024
Vanda reinstated 2024 financial guidance, projecting total revenues of $180-$210 million and year-end cash of $360-$390 million. The company also highlighted progress in its product pipeline, including the commercial launch of Fanapt® for bipolar I disorder and PONVORY® for multiple sclerosis in Q3 2024.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced it will release its second quarter 2024 financial results on Wednesday, July 31, 2024, after market close. The company will host a conference call at 4:30 PM ET on the same day to discuss the results and other corporate activities. Investors can participate by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 1278669.
The call will be broadcast live and archived on Vanda's website. A replay will be available from 8:30 PM ET on July 31 until 11:59 PM ET on August 7, 2024. The replay call-in numbers are 1-800-770-2030 (domestic) and 1-609-800-9909 (international), with the same passcode.
Vanda Pharmaceuticals announced that the U.S. District Court for the District of Delaware has allowed its patent lawsuit against Teva Pharmaceuticals and Apotex to proceed. The suit, filed in December 2022, alleges patent infringement related to HETLIOZ®. Teva and Apotex's motions for judgment on the pleadings were denied on June 27, 2024. The court determined that the issues of patentability require further claim construction and fact development. Vanda aims to seek an injunction to stop the defendants from marketing their generic versions of HETLIOZ® until the patent expires.
On June 19, 2024, Vanda Pharmaceuticals (Nasdaq: VNDA) announced its Board of Directors rejected unsolicited takeover proposals from Cycle Group Holdings and Future Pak The offers were $8.00 per share in cash from Cycle Group and $8.50-$9.00 per share in cash plus Contingent Value Rights (CVRs) from Future Pak. The Board determined these proposals undervalue Vanda, citing their clinical development pipeline, commercial presence, and significant cash balance. They deemed the CVRs speculative due to uncertain commercial milestones under Future Pak's management. Vanda remains confident in its long-term growth and value creation potential.
Vanda Pharmaceuticals has received a revised unsolicited takeover proposal from Future Pak, which offers $8.50-$9.00 per share in cash plus Contingent Value Rights. The proposal is currently non-binding. Vanda's Board, consulting with financial and legal advisors, will review this proposal to determine the best course of action for the company and its shareholders.
No immediate action is required from shareholders, and Vanda will not make further comments until the review is complete.
Vanda Pharmaceuticals confirmed receiving an unsolicited, non-binding indication of interest from Cycle Group Holdings to acquire the company for $8.00 per share in cash.
The Vanda Board of Directors will review the offer with their financial and legal advisors to determine the best course of action for the company and its shareholders.
No shareholder action is required at this time, and Vanda does not intend to comment further until the review is complete.