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 ...

Financial Data and Key Metrics Changes - Total revenues for the first six months of 2024 were $97.9 million, a 10% decrease compared to $108.6 million for the same period in 2023 [11] - For the second quarter of 2024, total revenues were $50.5 million, a 10% increase compared to $46.1 million for the second quarter of 2023 [16] - The company reported a net loss of $8.7 million for the first half of 2024 compared to net income of $4.8 million for the same period in 2023 [14] - Operating expenses for the first six months of 2024 were $117.3 million, an increase from $109.4 million in the same period in 2023 [15] Business Line Data and Key Metrics Changes - Fanapt net product sales were $43.7 million for the first six months of 2024, a 7% decrease compared to $47 million in the same period in 2023 [12] - HETLIOZ net product sales were $38.8 million for the first six months of 2024, a 37% decrease compared to $61.6 million in the same period in 2023 [13] - PONVORY net product sales were $15.4 million for the first six months of 2024, representing the second full quarter of revenue recognition following its acquisition [14] - For the second quarter of 2024, Fanapt net product sales were $23.2 million, a 4% decrease compared to $24.1 million in the second quarter of 2023 [17] - HETLIOZ net product sales were $18.7 million for the second quarter of 2024, a 15% decrease compared to $22 million in the second quarter of 2023 [18] - PONVORY net product sales were $8.6 million for the second quarter of 2024, an increase of 26% compared to $6.8 million in the first quarter of 2024 [18] Market Data and Key Metrics Changes - The company has expanded its sales force by three times to enhance its market presence and reach [22] - The number of Fanapt prescriber awareness programs scheduled for the third quarter of 2024 is more than three times larger than in the second quarter of 2024 [22] Company Strategy and Development Direction - The company is focusing on expanding its commercial organization to maximize the commercial value of Fanapt following its FDA approval for bipolar I disorder [5] - Plans are in place to initiate clinical programs for PONVORY in psoriasis and ulcerative colitis, aiming to diversify treatment options [7] - The company expects to reach full operational capacity for its marketing campaign by the fourth quarter of 2024 [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the prospects of revenue growth from the psychiatry franchise, particularly with the launch of Fanapt and PONVORY [6] - The company anticipates that HETLIOZ net product sales will likely decline significantly due to ongoing generic competition in the US [23] - Management remains confident in the approval process for Tradipitant, despite challenges faced with the FDA [10] Other Important Information - The company recorded cash, cash equivalents, and marketable securities of $387.7 million as of June 30, 2024, a slight decrease from previous periods [16] - The company reinstated financial guidance, expecting total net product sales from Fanapt, HETLIOZ, and PONVORY to be between $180 million and $210 million for 2024 [23] Q&A Session Summary Question: Feedback on prescriber perspective for Fanapt after label expansion - Management noted significant unmet medical needs in the market and positive early signs of new patient starts based on IQVIA data [25][27] Question: Response to potential new entrants in psychosis treatment - Management welcomed new entrants and emphasized the differentiating tolerability profile of Fanapt [29] Question: Commercial opportunities for Tradipitant in gastroparesis vs. motion sickness - Management highlighted the significant unmet medical need for gastroparesis and expressed confidence in the launch strategy for both indications [31][32] Question: Revenue guidance assumptions for PONVORY and Fanapt - Management indicated that the trajectory of launches would determine the revenue outcomes, with potential for higher sales if results are seen quickly [36] Question: Cash flow expectations heading into 2025 - Management discussed the potential for slight cash flow positivity if revenue growth is realized, while also considering ongoing investments [37] Question: Launch strategy for Tradipitant if approved - Management detailed a well-prepared launch plan, emphasizing relationships with key opinion leaders and understanding the target population [38]

Conference Call and Webcast to Follow Vanda will host a conference call at 4:30 PM ET on Wednesday, July 31, 2024, during which management will discuss the second quarter 2024 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 1278669. A replay of the call will be available on Wednesday, July 31, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, August 7, 2024, a ...

Vanda brought this suit in December 2022, alleging patent infringement against Teva and Apotex (the "Defendants"). The Defendants moved for judgment on the pleadings in April 2023. On June 27, 2024, the Court denied the motions. The Court concluded that the issues of patentability were not the same as those resolved in prior patent-infringement litigation between the parties. It further concluded that the Defendants raised issues that require claim construction and fact development before the Court can reso ...

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 March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34186 VANDA PHARMACEUTICALS INC. (Exact name of registrant as specified in its charter) Delaware 03-0491827 ( ...