Vanda Pharmaceuticals

VNDA

Market cap $319M

WASHINGTON , Dec. 4, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant. The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative framework established between Vanda and the FDA in October 2025.

Vanda reported strong phase 2 results for a candidate that could be used with GLP-1 drugs. However, this medicine's potential target market appears small and may shrink further.

FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold on long-term studies Separately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitant for the prevention of vomiting induced by motion (PDUFA target action date remains December 30, 2025) WASHINGTON , Nov. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), today announced the following updates regarding tradipitant for motion sickness: Partial Clinical Hold Re-Review Timeline Under the collaborative framework announced on October 1, 2025, the U.S. Food and Drug Administration (FDA) is conducting an expedited re-review of the partial clinical hold that currently restricts long-term clinical studies of tradipitant in motion sickness. The original target completion date was November 26, 2025.

Vanda Pharmaceuticals stands at a pivotal point, leveraging strong Fanapt growth and a robust late-stage pipeline for future expansion. VNDA's aggressive investment in commercial infrastructure has driven 31% Fanapt sales growth, but resulted in higher cash burn and quarterly losses. Key regulatory catalysts loom with PDUFA dates for Bysanti and tradipitant, and tradipitant's GLP-1 adjunct potential offers significant upside.

Vanda Pharmaceuticals stock rallies after phase II data show tradipitant sharply cuts Wegovy-related nausea and vomiting in overweight and obese adults.

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) on Monday released topline results from its randomized controlled clinical study (VP-VLY-686-2601) evaluating tradipitant to prevent nausea and vomiting induced by Wegovy.

Vanda's Tradipitant Study Success Positions it as Key Adjunct in $50B+ Global GLP-1 Agonist Market WASHINGTON , Nov. 17, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leading biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced positive topline results from its randomized controlled clinical study (VP-VLY-686-2601) evaluating tradipitant, an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of nausea and vomiting induced by GLP-1 receptor agonist Wegovy® in overweight and obese adults. This study, which pre-treated patients with either tradipitant or placebo before administering a 1 mg injection of Wegovy®, a dose that normally takes 9 weeks of titration to reach, succeeded and met its primary endpoint, with only 29.3% of tradipitant-treated participants (17/58) experiencing vomiting compared to 58.6% on placebo (34/58) (p=0.0016), representing a 50% relative reduction.

WASHINGTON , Nov. 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Stifel 2025 Healthcare Conference in New York City on Wednesday, November 12, 2025. A corporate presentation is scheduled for 4:40 p.m.

Vanda Pharmaceuticals Inc. ( VNDA ) Q3 2025 Earnings Call October 29, 2025 4:30 PM EDT Company Participants Kevin Moran - Senior VP, CFO & Treasurer Mihael Polymeropoulos - Founder, President, CEO & Chairman of The Board Conference Call Participants Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division Olivia Brayer - Cantor Fitzgerald & Co., Research Division Presentation Operator Hello, and thank you for standing by.

Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to a loss of $0.09 per share a year ago.