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. develops and commercializes biopharmaceutical therapies, with company updates centered on prescription products and clinical or regulatory programs. Recurring news includes financial results, Fanapt sales trends, HETLIOZ commercialization, the U.S. availability of NEREUS (tradipitant) for prevention of vomiting induced by motion, and FDA approval of BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia.
Vanda news also covers development activity for imsidolimab in generalized pustular psoriasis, product-access and commercial-channel updates, investor conference participation, regulatory-policy statements, and corporate governance changes such as board appointments.
Vanda Pharmaceuticals (VNDA) has received FDA Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide-based JAK2 inhibitor designed to treat polycythemia vera (PV). PV is a rare blood cancer affecting approximately 1 in 2000 Americans, characterized by excessive red blood cell production.
VGT-1849A specifically targets JAK2, potentially offering advantages over current treatments like Jakafi®, Inrebic®, Ojjaara®, and Vonjo® which lack selective targeting. This specificity could reduce infection risks and toxic effects associated with broader JAK inhibition. The treatment represents Vanda's second precision medicine therapeutic, following VCA-894A for Charcot-Marie-Tooth disease.
Vanda Pharmaceuticals (VNDA) has announced its participation in two major investor conferences in November 2024. The company will deliver a corporate presentation at the Stifel 2024 Healthcare Conference on November 19 at 9:45 a.m. ET, followed by a fireside chat at the Jefferies 2024 London Healthcare Conference on November 21 at 11:30 a.m. GMT. Both events will be accessible live through Vanda's corporate website, with archived recordings available for approximately 30 days afterward.
Vanda Pharmaceuticals reported Q3 2024 total net product sales of $47.7 million, a 23% increase from Q3 2023. Fanapt sales grew 12% to $23.9 million, while HETLIOZ sales increased 2% to $17.9 million. PONVORY contributed $5.9 million. The company reported a net loss of $5.3 million compared to net income of $0.1 million in Q3 2023. Cash position stood at $376.3 million. The company raised its full-year 2024 revenue guidance to $190-$210 million and expects year-end cash of $370-$390 million.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced it will release its third quarter 2024 financial results on Wednesday, November 6, 2024, after market close. The company will host a conference call at 4:30 PM ET the same day to discuss the financial results and corporate activities. The call will be accessible via phone and webcast through the company's website. A replay will be available from 8:30 PM ET on November 6 until November 13, 2024.
Vanda Pharmaceuticals confirmed receipt of a second unsolicited, non-binding proposal from Cycle Group Holdings to acquire the company for $8.00 per share in cash. This proposal, received on September 23, 2024, is economically identical to the previously rejected offer from May 24, 2024. Vanda's Board of Directors unanimously determined that the proposal substantially undervalues the company and is not in the best interests of Vanda and its stockholders.
The Board evaluated all aspects of Vanda's business, including its clinical development pipeline, expanding commercial presence, and significant cash balance. They concluded that the proposal is an opportunistic attempt to purchase shares at a discount to Vanda's intrinsic value. The Board and management remain confident in Vanda's growth profile and long-term value creation potential, which they believe far exceeds the consideration offered by Cycle Group.
Cycle Pharmaceuticals has reaffirmed its proposal to acquire Vanda Pharmaceuticals (NASDAQ: VNDA) for $8.00 per share in an all-cash transaction. This offer represents an 80% premium to Vanda's closing share price on October 11, 2024, and values the company at $488 million on a fully diluted basis.
Cycle criticizes Vanda's board for refusing to engage and for implementing bylaw amendments that Cycle views as entrenching efforts. The proposal comes after Vanda's recent failure to receive FDA approval for tradipitant following an unsuccessful Phase 3 trial.
Cycle urges Vanda shareholders to express their views on the proposal to the independent directors of Vanda's board. The company states it has substantial cash on hand and is confident in obtaining committed financing for the transaction.
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.