Core Message - Vanda Pharmaceuticals Inc has issued a letter to FDA Commissioner Robert M Califf MD highlighting concerns over the FDA's review process for its New Drug Application (NDA) for tradipitant a treatment for gastroparesis [1][2][3] FDA Review Process - Vanda submitted an NDA for tradipitant for the treatment of gastroparesis on September 18 2023 and received a Complete Response Letter (CRL) from the FDA on September 18 2024 [2][4] - The CRL was criticized by Vanda for lacking reasoned explanations and failing to engage with the evidence presented including voluminous evidence from experts [4] - Vanda expressed surprise at the disregard for facts evidence and basic scientific principles in the CRL which they argue does not reflect a legitimate regulatory review [4] FDA Advisory Committees - FDA denied Vanda's request to convene an Advisory Committee to consider the tradipitant application [5] - The number of Advisory Committee meetings convened by the FDA has drastically declined from 55% of drug applications in 2010 to 6% in 2021 [5] - FDA Commissioner Robert Califf has stated a preference for less voting by advisory committees and expressed skepticism about the value of votes which Vanda argues contributes to a lack of public scrutiny of FDA decisions [5] Communication and Accountability - Vanda wrote to Dr Nikolov expressing concerns about the CRL but received no acknowledgment or response three months later [4] - Vanda criticizes the FDA's opacity in decision-making and oversight which they argue fosters a culture of obfuscation and close-mindedness [3][4] - Vanda emphasizes the need for FDA policies practices and culture to align with scientific evidence and the law [6] Company Background - Vanda Pharmaceuticals Inc is a global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs [9]

Company Overview - Vanda Pharmaceuticals Inc (VNDA) generates revenue from three commercial products: Fanapt, Hetlioz, and Ponvory [1] - Fanapt is approved in the US for schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder [1] - Hetlioz is approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome [1] - Ponvory is an oral treatment for relapsing forms of multiple sclerosis, with US and Canada rights acquired from Actelion Pharmaceuticals Limited (a JNJ subsidiary) in December 2023 [2] Stock Performance - VNDA shares gained 13.9% in the past year, outperforming the industry's 16% decline [3] Pipeline Development - Vanda has a promising pipeline targeting neuroscience, immunology, and oncology indications [4] - Two pipeline candidates, tradipitant (for motion sickness-induced vomiting) and milsaperidone (for schizophrenia and acute bipolar I disorder), are expected to have FDA regulatory filings submitted shortly [4] - VGT-1849A, a novel antisense oligonucleotide (ASO)-based JAK2 inhibitor, received FDA Orphan Drug designation for treating polycythemia vera (PV) and other JAK2-driven hematologic malignancies [5][7] Financial Outlook - Vanda currently holds a Zacks Rank 1 (Strong Buy) [8] - Estimates for Vanda's 2025 loss per share have narrowed from 53 cents to 35 cents in the past 60 days [8] Industry Comparison - Other top-ranked biotech stocks include Puma Biotechnology Inc (PBYI) and Castle Biosciences Inc (CSTL), both with Zacks Rank 1 [9] - PBYI's 2025 EPS estimates increased from 42 cents to 54 cents in the past 60 days, despite a 38.8% share price decline over the past year [9] - CSTL's 2025 loss per share estimates narrowed from $1.88 to $1.84 in the past 60 days, with shares surging 30.9% over the past year [10] - PBYI beat earnings estimates in three of the trailing four quarters, with an average surprise of 32.78% [10] - CSTL beat earnings estimates in all four trailing quarters, with an average surprise of 172.72% [10]

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA ) is a net-net with an upcoming Q4 earnings report. I think the report has the potential to send the company's share price much higher. These two pieces of information set up a trade thatAnalyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for ...

WASHINGTON, Dec. 20, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2000 Americans.1 PV is a chronic myeloproliferative disorder characterized by aberrant hematopoiesis of myeloid lineage with e ...

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 | --- | --- | |---------------------------------------------------------------------------------------------------|---------------------------------------------------- ...

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Q3 2024 Earnings Conference Call November 6, 2024 4:30 PM ET Company Participants Kevin Moran – Chief Financial Officer Mihael Polymeropoulos – Chairman, President and Chief Executive Officer Tim Williams – General Counsel Conference Call Participants Charles Duncan – Cantor Ram Selvaraju – H.C. Wainwright Operator Hello, and thank you for standing by. At this time, I would like to welcome you to the Q3 2024 Vanda Pharmaceuticals Inc. Earnings Conference Call. All li ...

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 ...