Vanda Pharma - VNDA STOCK NEWS

Vanda Pharmaceuticals (Nasdaq: VNDA) has announced it will release its fourth quarter and full year 2024 financial results on Thursday, February 13, 2025, after market close. The company will host a conference call at 4:30 PM ET on the same day to discuss the financial results and other corporate activities.

Participants can join the conference call by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 2881765. The call will be simultaneously broadcast and archived on Vanda's website. A replay will be available from 8:30 PM ET on February 13 until February 20, 2025, at 11:59 PM ET.

Vanda Pharmaceuticals (VNDA) and AnaptysBio announced an exclusive global license agreement for imsidolimab, an IL-36R antagonist that has completed two Phase 3 trials for Generalized Pustular Psoriasis (GPP). Under the agreement, Vanda will pay $15 million upfront ($10M payment plus $5M for drug supply) and will receive exclusive global rights to develop, manufacture, and commercialize imsidolimab.

The drug has successfully completed GEMINI-1 and GEMINI-2 global Phase 3 trials for GPP, a rare skin disorder affecting between 1.76 and 124 patients per million people worldwide. Vanda plans to prepare BLA and MAA applications for US and EU markets in 2025. AnaptysBio is eligible for up to $35 million in future regulatory and sales milestones, plus a 10% royalty on net sales.

Vanda Pharmaceuticals (VNDA) has accepted the FDA's opportunity for a hearing regarding its New Drug Application (NDA) for tradipitant in gastroparesis treatment. The company submitted the NDA in September 2023, which was rejected via a Complete Response Letter in September 2024. The FDA cited insufficient evidence of efficacy despite positive results from Study 1 showing significant improvement in nausea severity.

The clinical program included two placebo-controlled studies and one open-label study. Study 1 (152 patients) demonstrated statistically significant improvement in nausea at week 4, while Study 2 (201 patients) showed numerical but not statistically significant improvements versus placebo. Over 1,000 people have been treated with tradipitant, with some receiving treatment for more than a year through an expanded access program.

Vanda disagrees with the FDA's assessment and argues that the evidence meets the statutory standard of 'substantial evidence' required for approval. No new drug has been approved for gastroparesis in over 40 years.

Vanda Pharmaceuticals (NASDAQ: VNDA) has issued a letter to FDA Commissioner Robert M. Califf addressing concerns over the agency's rejection of its New Drug Application (NDA) for tradipitant, a treatment for gastroparesis symptoms. The letter follows a Complete Response Letter (CRL) received on September 18, 2024, which denied approval for the drug.

The company criticizes the FDA's review process, highlighting several issues including: the lack of response from Dr. Nikolov to their concerns about the CRL, the denial of their request for an Advisory Committee meeting, and what they describe as a 'disturbing pattern of conduct' at the FDA. The letter points out a significant decline in Advisory Committee meetings, from 55% of drug applications in 2010 to 6% in 2021.

Vanda argues that the FDA's current policies and practices need realignment with scientific evidence and law, particularly questioning the Commissioner's stance on only overruling civil servants' decisions in cases of 'corruption' or 'temporary insanity.'

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.