Vanda Pharmaceuticals Inc. Stock News

WASHINGTON , Oct. 1, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ® (tasimelteon) and tradipitant. Key features of the agreement include: The FDA will conduct an expedited re-review of the partial clini...

WASHINGTON , Sept. 25, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial" in PLOS One, a leading open-access journal.1 In the study, published on September 24, 2025 ...

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.