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Vanda Pharmaceuticals

Positive
Neutral
Negative
Sentiment 3-Months
Positive
Neutral 76.9%
Negative

Neutral
PRNewsWire
9 days ago
Monumental Sports & Entertainment Taps D.C.'s Own Vanda Pharmaceuticals as Founding Partner to Help Drive the Creation of Brand-New Downtown Arena
Multiyear agreement includes exclusive Monumental Sports Network studio entitlement, activations across Capitals, Wizards, and Mystics, and deep integration via community and media platforms For photos of the new Vanda Pharmaceuticals Studio and video announcing the partnership, please CLICK HERE. WASHINGTON , Oct. 8, 2025 /PRNewswire/ -- Monumental Sports & Entertainment (MSE) today announced Vanda Pharmaceuticals (Nasdaq: VNDA), a leading global biopharmaceutical company headquartered in Washington, D.C.
Monumental Sports & Entertainment Taps D.C.'s Own Vanda Pharmaceuticals as Founding Partner to Help Drive the Creation of Brand-New Downtown Arena
Neutral
PRNewsWire
16 days ago
Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
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 clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025.
Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
Neutral
PRNewsWire
22 days ago
Vanda Pharmaceuticals announces the publication in PLOS One of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial"
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 in PLOS One, HETLIOZ® met its primary endpoint, demonstrating a mean improvement in latency to persistent sleep (LPS) from baseline to the average of Nights 1 and 8 of 44.9 minutes (20 mg) and 46.3 minutes (50 mg) versus 28.2 minutes (placebo) (p 
Vanda Pharmaceuticals announces the publication in PLOS One of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial"
Positive
Seeking Alpha
1 month ago
Vanda: Next Phase Of Fanapt Growth Might Be With Bysanti Advancement
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 granted Orphan Drug Designation, targeting a growing $2B market by 2032.
Vanda: Next Phase Of Fanapt Growth Might Be With Bysanti Advancement
Neutral
PRNewsWire
1 month ago
Vanda Pharmaceuticals Announces Participation at September 2025 Investor Conferences
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.
Vanda Pharmaceuticals Announces Participation at September 2025 Investor Conferences
Neutral
PRNewsWire
1 month ago
Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation for VGT-1849B, a Novel and Selective Candidate for the Treatment of Polycythemia Vera
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 lineage with exuberant red cell production and increased release of pro-inflammatory cytokines.
Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation for VGT-1849B, a Novel and Selective Candidate for the Treatment of Polycythemia Vera
Neutral
PRNewsWire
1 month ago
Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®
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 of Generic Drugs decision to approve two generic versions of Hetlioz®. In 2023, Vanda filed citizen petitions challenging the FDA's approval of two generic versions of Vanda's drug Hetlioz®.
Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®
Neutral
PRNewsWire
2 months ago
In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
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.
In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
Negative
The Motley Fool
2 months ago
Vanda (VNDA) Q2 Revenue Rises 4%
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 (VNDA) Q2 Revenue Rises 4%
Neutral
Seeking Alpha
2 months ago
Vanda Pharmaceuticals Inc. (VNDA) Q2 2025 Earnings Call Transcript
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.
Vanda Pharmaceuticals Inc. (VNDA) Q2 2025 Earnings Call Transcript