Core Insights - Vanda Pharmaceuticals Inc. has received Orphan Drug Designation from the FDA for VGT1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor aimed at treating polycythemia vera (PV), a rare hematologic malignancy affecting approximately 1 in 2000 Americans [1][8] - The ASO VGT1849A selectively reduces JAK2 levels, potentially suppressing JAK2V617F-driven pathogenic signaling and malignant proliferation of hematopoietic cells [1][9] - This designation represents a significant milestone in precision medicine for hematological malignancies, marking Vanda's second precision medicine therapeutic following VCA-894A for Charcot-Marie-Tooth disease [2] Company Overview - Vanda Pharmaceuticals is focused on developing innovative therapies to meet high unmet medical needs and improve patient lives [16] - The company aims to provide targeted efficacy with an improved safety profile through its selective targeting of JAK2, differentiating itself from currently available small molecule inhibitors that may have off-target effects [15] Product Details - VGT1849A is designed to alleviate the disease burden faced by PV patients by selectively targeting JAK2, which is implicated in over 95% of PV cases due to the JAK2 V617F mutation [8][9] - The potential benefits of VGT1849A include a favorable safety profile and convenient dosing, which may enhance the quality of life for patients with PV [8][9]

WASHINGTON, Nov. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in November 2024:The Stifel 2024 Healthcare Conference on Tuesday, November 19, 2024. A corporate presentation is scheduled for 9:45 a.m. Eastern Time.The Jefferies 2024 London Healthcare Conference on Thursday, November 21, 2024. A fireside chat is scheduled for 11:30 a.m. Greenwich Mean Time (6:30 a.m. Eastern Time).The ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |---------------------------------------------------------------------------------------------------|---------------------------------------------------- ...

Exhibit 99.1 Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results • Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 • Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges ® • Fanapt launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 • Fanapt long acting injectable program expected to be initiated in Q4 2024 ® • Milsaperidone NDA for schizophrenia and bipolar I disorde ...

HC Wainwright initiated coverage on Vanda Pharmaceuticals, Inc. VNDA, a commercial-stage biopharmaceutical firm primarily focusing on neurological and neuropsychiatry disorders.HC Wainwright sees Vanda as having a well-established commercial portfolio, with multiple line extensions and life cycle management opportunities across its three key franchises: Fanapt, Hetlioz, and Ponvory.The analyst notes a pipeline of promising programs with numerous opportunities for significant clinical and regulatory mileston ...

Conference Call and Webcast to FollowWASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2024 on Wednesday, November 6, 2024, after the market closes.Vanda will host a conference call at 4:30 PM ET on Wednesday, November 6, 2024, during which management will discuss the third quarter 2024 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (dom ...

Vanda Pharmaceuticals Inc. (VNDA) announced that the FDA issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis. Shares of the company were down 6.1% on Sept. 19 following the announcement of the news. Marked by delayed gastric emptying, gastroparesis is a serious condition that slows down the stomach's ability to empty its contents. The FDA has not approved any effective medicine for t ...

Core Viewpoint - Vanda Pharmaceuticals' stock experienced a significant decline following the FDA's rejection of its New Drug Application for tradipitant, impacting market enthusiasm for the company [1][2]. Group 1: FDA Rejection - The FDA declined to approve Vanda's New Drug Application for tradipitant, intended for treating gastroparesis, a stomach disorder [2]. - The FDA provided a Complete Response Letter (CRL) detailing its rejection, which Vanda criticized as being dismissive of the evidence presented and suggesting further studies that were inconsistent with expert advice [3]. Group 2: Company Response and Future Plans - Vanda plans to continue pursuing the commercialization of tradipitant despite the setback and will maintain support for an expanded-access program for gastroparesis patients [5]. - The company is also exploring tradipitant for additional indications, including motion sickness and atopic dermatitis, although only gastroparesis has been submitted for FDA approval [4].

Company Participation - Vanda Pharmaceuticals Inc. will participate in the Wells Fargo 2024 Healthcare Conference in Boston on September 6, 2024 [1] - A corporate presentation is scheduled for 11:00 a.m. Eastern Time [1] Access to Presentation - The corporate presentation can be accessed live on Vanda's corporate website [2] - Investors are advised to arrive at the conference website at least 15 minutes early for registration and software installation [2] - An archived version of the conference will be available on Vanda's website for approximately 30 days [2] Company Overview - Vanda Pharmaceuticals Inc. is a leading global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs [3] - The company aims to improve the lives of patients [3]

Morsa Images Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) is a takeover target. The company received an $8.00 per share bid from Cycle Pharmaceuticals. It also received an upwards-revised bid of $8.50 to $9.00 from Future Pak, that included up to $260 million of potential contingent value right payments, bringing the total consideration to $12.77-$13.27 a share. Despite these two bids, the market did not feel great confidence in either one being accepted, as the stock price never exceeded $7.00 while these bids ...