WASHINGTON , May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this ...
Conference Call and Webcast to Follow WASHINGTON , May 2, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2025 on Wednesday, May 7, 2025, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, May 7, 2025, during which management will discuss the first quarter 2025 financial resu...
WASHINGTON , April 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary, and reductions in force.
WASHINGTON , April 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced participation at the American Academy of Neurology (AAN) Annual Meeting, to be held in San Diego, California from April 5 through April 9, 2025. The following will be presented: April 9, 2025 Presentation Title: "Translating IGHMBP2 Variants with a CMT2S Patient-specific Organ-on-a-ch...
WASHINGTON , March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the effic...
WASHINGTON , Feb. 24, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article entitled "Potential ASO-based personalized treatment for Charcot-Marie-Tooth disease type 2S" in Molecular Therapy Nucleic Acids1, a Cell Press partner journal, that describes the development of a novel antisense oligonucleotide (ASO) therapeutic, VCA-894A, ...
Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA ) Q4 2024 Earnings Conference Call February 13, 2025 4:30 PM ET Company Participants Kevin Moran - SVP, CFO & Treasurer Mihael Polymeropoulos - Founder, President, CEO & Chairman Conference Call Participants Charles Duncan - Cantor Fitzgerald Raghuram Selvaraju - H.C. Wainwright Andrew Tsai - Jefferies Operator Hello, and thank you for standing by.
Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023 Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt® MAA for bipolar I d...
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