Vanda Pharma's revenue growth is driven by Fanapt's label expansion to bipolar I disorder, offsetting declines in HETLIOZ and PONVORY sales. Upcoming catalysts include Bysanti's PDUFA date for bipolar I/schizophrenia (Feb 2026) and phase 3 data for MDD, plus tradipitant's motion sickness PDUFA (Dec 2025). Vanda's pipeline features a selective JAK2 inhibitor for polycythemia vera, recently grant...
WASHINGTON , Aug. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in September 2025: The Cantor Global Healthcare Conference 2025 in New York City on Wednesday, September 3, 2025. A corporate presentation is scheduled for 3:55 p.m.
WASHINGTON , Aug. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor for the treatment of polycythemia vera (PV). PV is a chronic myeloproliferative disorder characterized by aberrant hematopoiesis of myeloid...
WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review the decision made by Jacqueline Corrigan-Curay, the departing director of the FDA's Center for Drug Evaluation and Research (CDER), days before her retirement that upholds an Office ...
WASHINGTON , Aug. 18, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ® (tasimelteon) to treat jet lag disorder (Vanda Pharmaceuticals Inc. v. FDA, case no.
Vanda Pharmaceuticals (VNDA -8.78%), a pharmaceutical company focused on central nervous system and rare disease treatments, reported financial results for Q2 2025 on July 31, 2025. The most important news was a GAAP net loss of $27.2 million for Q2 2025, driven by sharply higher operating costs.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA ) Q2 2025 Earnings Call July 31, 2025 8:00 AM ET Company Participants Kevin Patrick Moran - Senior VP, CFO & Treasurer Mihael H. Polymeropoulos - Founder, President, CEO & Chairman of The Board Conference Call Participants Lin Tsai - Jefferies LLC, Research Division Olivia Simone Brayer - Cantor Fitzgerald & Co., Research Division Raghuram Selvaraju - H.C.
Fanapt® Q2 2025 net product sales increased by 27% to $29.3 million compared to Q2 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be subm...
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