Vanda Pharmaceuticals (VNDA) Company Report

Vanda Pharmaceuticals' oral drug Nereus (tradipitant) received FDA approval to prevent motion-induced vomiting, marking the first new pharmacologic treatment for the condition in over 40 years.
Following the approval, VNDA shares jumped roughly 18–20% in premarket/overnight trading and traded above prior 52-week highs in after-hours activity.
Analysts project peak U.S. sales for Nereus could exceed $100 million, though commercial success will depend on pricing, insurance coverage, and launch execution.
Vanda expects to launch Nereus in the coming months and is also advancing tradipitant in trials for gastroparesis and GLP-1-induced nausea.

1 day ago

Morningstar

Vanda Pharmaceuticals Announces FDA Approval of NEREUS™

VNDA

Product Launch

New Projects/Investments

Vanda Pharmaceuticals announced the FDA approval of NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion.
This approval marks the first new pharmacologic treatment for motion sickness in over four decades.
NEREUS™ demonstrated significant reductions in vomiting in pivotal clinical trials, with incidence rates of 18.3–19.5% in Motion Syros compared to 44.3% with placebo, and 10.4–18.3% in Motion Serifos compared to 37.7% with placebo.
Vanda anticipates launching NEREUS™ in the coming months and is also advancing tradipitant in clinical development for other indications, including gastroparesis.

1 day ago

Press Release

Vanda Pharmaceuticals Submits BLA for Imsidolimab to FDA

VNDA

Product Launch

New Projects/Investments

Vanda Pharmaceuticals submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, an IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP).
The BLA is supported by positive results from the global Phase 3 GEMINI-1 and GEMINI-2 studies, which demonstrated rapid disease clearance and a favorable safety profile.
Vanda has requested priority review for the BLA, citing GPP's status as a rare orphan disease with significant unmet need, potentially leading to FDA approval as early as mid-2026.
Imsidolimab is expected to have regulatory and patent exclusivity extending into the late 2030s.

Dec 15, 2025, 12:00 PM

Press Release

Vanda Pharmaceuticals: FDA Lifts Partial Clinical Hold on Tradipitant

VNDA

Product Launch

The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on Vanda Pharmaceuticals Inc.'s tradipitant for motion sickness.
This decision followed Vanda's formal dispute resolution request, with the FDA concluding that motion sickness is an acute, event-driven therapy, thereby eliminating the need for an additional six-month dog toxicity study.
The lift allows Vanda to extend clinical studies of tradipitant in motion sickness.
The New Drug Application (NDA) for tradipitant for the prevention of vomiting induced by motion remains on track for review, with a PDUFA target action date of December 30, 2025.

Dec 4, 2025, 9:39 PM

8-K

Vanda Pharmaceuticals: FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness

VNDA

Product Launch

New Projects/Investments

The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on Vanda Pharmaceuticals' protocol VP-VLY-686-3403 for tradipitant, which previously limited its use to 90 doses.
This decision allows Vanda to extend clinical studies of tradipitant in motion sickness, following the FDA's agreement that motion sickness is an acute, self-limiting response, thereby eliminating the need for an additional six-month dog toxicity study.
The New Drug Application (NDA) for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025.
If approved, tradipitant is positioned as potentially the first new pharmacologic treatment for motion sickness in over 40 years.

Dec 4, 2025, 9:21 PM

Press Release

Vanda Pharmaceuticals provides regulatory update on Tradipitant for motion sickness

VNDA

Product Launch

New Projects/Investments

The U.S. Food and Drug Administration (FDA) and Vanda Pharmaceuticals Inc. agreed to extend the expedited re-review of the partial clinical hold on long-term studies of Tradipitant for motion sickness to December 5, 2025, to accommodate personnel and leadership transitions within the Center for Drug Evaluation and Research (CDER).
The PDUFA target action date for the New Drug Application (NDA) of Tradipitant for the prevention of vomiting induced by motion remains December 30, 2025.
Formal labeling discussions between the FDA and Vanda Pharmaceuticals Inc. have commenced for the Tradipitant NDA.

Nov 28, 2025, 12:06 PM

8-K

Vanda Pharmaceuticals Updates Tradipitant Regulatory Timelines

VNDA

New Projects/Investments

Guidance Update

The U.S. Food and Drug Administration (FDA) and Vanda Pharmaceuticals Inc. have agreed to extend the expedited re-review of the partial clinical hold on long-term studies of tradipitant to December 5, 2025, from the original target completion date of November 26, 2025. This extension was requested by the FDA due to recent personnel and leadership transitions.
The PDUFA target action date for the New Drug Application (NDA) of tradipitant for the prevention of vomiting induced by motion remains December 30, 2025.
Labeling discussions between the FDA and Vanda have formally commenced, following the FDA's recent comments on the proposed labeling for tradipitant.

Nov 28, 2025, 12:00 PM

Press Release

Vanda Pharmaceuticals Reports Positive Tradipitant Study Results

VNDA

New Projects/Investments

Vanda Pharmaceuticals announced positive topline results from a randomized controlled clinical study (VP-VLY-686-2601) evaluating tradipitant for the prevention of nausea and vomiting induced by the GLP-1 receptor agonist Wegovy®.
The study met its primary endpoint, demonstrating a 50% relative reduction in vomiting, with only 29.3% of tradipitant-treated participants experiencing vomiting compared to 58.6% on placebo.
Tradipitant also met the key secondary endpoint, reducing the proportion of participants with vomiting and significant nausea to 22.4% in the tradipitant group versus 48.3% on placebo.
These results suggest tradipitant's potential to mitigate GLP-1 induced side effects, which contribute to 30-50% real-world discontinuation rates for GLP-1 agonists, within a global market that exceeded $50 billion through the first nine months of 2025.
Vanda anticipates initiating a Phase III program in the first half of 2026 to pursue regulatory approval for this unmet need.

Nov 17, 2025, 11:37 PM

Press Release

Vanda Pharmaceuticals Provides Business Update and Financial Guidance

VNDA

Guidance Update

Product Launch

New Projects/Investments

Vanda Pharmaceuticals reported a strong financial position with approximately $294 million in cash and no debt as of the third quarter of 2025. The company's 2025 guidance projects total revenues of $210 million-$230 million and an ending cash balance of $260 million-$290 million.
For Q3 2025, Vanda's total revenue was $56.3 million, comprising $31.2 million from Fanapt, $18 million from Hetlioz, and $7 million from Ponvory.
The company anticipates several key regulatory decisions, including a PDUFA target action date of December 30 for tradipitant in motion sickness, an FDA decision by January 7, 2026, for Hetlioz in jet lag, and a February 2026 PDUFA date for Basanti in bipolar disorder and schizophrenia.
Vanda is advancing its pipeline with a BLA submission for Imsidolumab in GPP expected by the end of 2025 and Phase 2 results for tradipitant in GLP-1 induced nausea anticipated in Q4 2025. The company also significantly expanded its Fanapt sales force to approximately 300 representatives by mid-2025.

Nov 12, 2025, 9:40 PM

Transcript

AnaptysBio Discontinues Rosnilimab Ulcerative Colitis Trial

VNDA

New Projects/Investments

Guidance Update

AnaptysBio's investigational rosnilimab failed to meet primary or key secondary endpoints at Week 12 in its Phase 2 trial for moderate-to-severe ulcerative colitis (UC).
The company will discontinue the UC trial, which is expected to result in at least $10 million in savings.
AnaptysBio anticipates ending 2025 with approximately $300 million in cash, including an expected $75 million commercial sales milestone from GSK in Q4 2025.
The company plans to provide an update in H1 2026 on the advancement of rosnilimab in rheumatoid arthritis (RA) and intends to separate its biopharma operations from royalty assets in 2026.