Vanda Pharmaceuticals (VNDA) Company Report

Vanda Pharmaceuticals recently received FDA approval for Nereus for vomiting induced by motion on December 30th, with a commercial launch anticipated in the second half of 2026.
The company has an upcoming PDUFA date of February 21st, 2026, for Bysanti in bipolar I disorder and schizophrenia, and expects Phase 3 results for Bysanti in Major Depressive Disorder (MDD) in 2026.
A Biologics License Application (BLA) for Imsidolimab in generalized pustular psoriasis (GPP) was submitted in Q4 2025, with a potential PDUFA date in summer 2026 if priority review is granted.
Vanda reported $56.3 million in revenue for Q3 2025, reaffirmed its full-year 2025 revenue guidance of $210 million-$230 million, and expects year-end 2025 cash of $260 million-$290 million. The company also aims to have six commercial products on the market by the end of 2026 and maintains a strong debt-free balance sheet.

Jan 15, 2026, 5:00 PM

Transcript

Vanda Pharmaceuticals Provides Business Update and 2025 Financial Guidance

VNDA

Guidance Update

Product Launch

New Projects/Investments

Vanda Pharmaceuticals reported Q3 2025 total revenue of $56.3 million and reaffirmed its 2025 total revenue guidance of $210 million-$230 million and year-end cash guidance of $260 million-$290 million.
The company received FDA approval for Nereus for motion sickness on December 30, 2025, with a commercial launch planned for the second half of 2026. Nereus also has a Phase 3 program for GLP-1 induced vomiting starting in the first half of 2026.
An upcoming PDUFA date for Bysanti (for bipolar I disorder and schizophrenia) is set for February 21, 2026, which is crucial for extending the psychiatry portfolio beyond Fanapt's expected loss of exclusivity in late 2027. Phase 3 results for Bysanti in Major Depressive Disorder (MDD) are also expected in 2026.
The Biologics License Application (BLA) for Imsidolimab in Generalized Pustular Psoriasis (GPP) was submitted in Q4 2025, with a potential PDUFA date in summer 2026 if priority review is granted.
Fanapt demonstrated strong commercial performance, with 35% growth in total prescriptions and 147% growth in new-to-brand prescriptions between Q3 2024 and Q3 2025.

Jan 15, 2026, 5:00 PM

Transcript

Vanda Pharmaceuticals Highlights Q3 2025 Results, Upcoming Catalysts, and Pipeline Expansion

VNDA

Guidance Update

Product Launch

New Projects/Investments

Vanda Pharmaceuticals reported Q3 2025 total revenue of $56.3 million, with full-year 2025 revenue guidance set at $210 million-$230 million and year-end 2025 cash guidance at $260 million-$290 million.
The company has several near-term regulatory catalysts, including a PDUFA date for Bysanti on February 21st, 2026, for bipolar I disorder and schizophrenia, and a potential PDUFA date for imsidolimab in summer 2026 for generalized pustular psoriasis.
NEREUS received FDA approval for motion sickness on December 30th, with a commercial launch anticipated in the second half of 2026, and a Phase III program for GLP-1 induced vomiting is expected to start in the first half of 2026.
Vanda aims to expand its commercial portfolio to six products by the end of 2026, with Bysanti Phase III results for Major Depressive Disorder expected in 2026.
Fanapt demonstrated significant commercial growth between Q3 2024 and Q3 2025, with 35% growth in total prescriptions and 147% growth in new-to-brand prescriptions.

Jan 15, 2026, 5:00 PM

Transcript

Vanda Pharmaceuticals Provides 2025 Financial Guidance and Updates on Product Portfolio and Pipeline

VNDA

Guidance Update

Product Launch

New Projects/Investments

Vanda Pharmaceuticals provided 2025 financial guidance projecting total revenues between $210 million and $230 million and year-end cash between $260 million and $290 million. For Q3 2025, the company reported total revenues of $56.3 million and a cash balance of $293.8 million.
The company received FDA approval for NEREUS™ for the prevention of vomiting induced by motion on December 30, 2025, with commercial launch expected in 2H 2026.
Upcoming regulatory milestones include a PDUFA target action date of February 21, 2026, for Bysanti™ in bipolar I disorder and schizophrenia, and an expected 2H 2026 PDUFA target action date for imsidolimab in generalized pustular psoriasis.
On January 7, 2026, the FDA concluded that the supplemental New Drug Application for HETLIOZ® for jet lag disorder cannot be approved in its current form.

Jan 15, 2026, 12:00 PM

Presentation

Vanda Pharmaceuticals' Hetlioz for Jet Lag Rejected by FDA

VNDA

Legal Proceedings

Product Launch

The FDA has again rejected Vanda Pharmaceuticals' supplemental New Drug Application (NDA) to expand Hetlioz (tasimelteon) for jet lag, issuing a Complete Response Letter despite acknowledging "positive efficacy" in trials. The agency concluded that the trial protocols were not sufficiently analogous to real-world air travel, a conclusion Vanda disputes, stating its data meets effectiveness standards and that it will continue to pursue the matter.
This rejection follows litigation that compelled the FDA to re-review the application, with a judge ruling in Vanda's favor in January 2024 and ordering the FDA to resolve the application or grant a hearing.
Vanda's shares fell approximately 11–12% to about $7.60 apiece on the news.
Analysts at H.C. Wainwright reiterated a Buy rating and $22 price target, noting the company's strong financial position and that prior models did not assume jet-lag sales, limiting the immediate financial impact.

Jan 8, 2026, 1:24 PM

Morningstar

Vanda Pharmaceuticals receives FDA decision letter on HETLIOZ sNDA for jet lag disorder

VNDA

Product Launch

Legal Proceedings

Vanda Pharmaceuticals Inc. announced on January 8, 2026, that it received a decision letter from the FDA concluding that its supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form.
The FDA acknowledged positive efficacy from Vanda’s controlled clinical trials but stated that these data do not provide substantial evidence of effectiveness, primarily because controlled phase advance protocols were not considered sufficiently analogous to actual jet travel conditions.
Vanda disagrees with the FDA's interpretation, maintaining that the submitted dataset meets the statutory standard for effectiveness and is committed to pursuing all appropriate avenues to advance approval.

Jan 8, 2026, 12:09 PM

8-K

Vanda Pharmaceuticals receives FDA decision letter on HETLIOZ® jet lag disorder sNDA

VNDA

Legal Proceedings

Product Launch

Vanda Pharmaceuticals (VNDA) announced that the FDA's Center for Drug Evaluation and Research (CDER) issued a decision letter stating that the supplemental New Drug Application (sNDA) for HETLIOZ® for jet lag disorder cannot be approved in its current form.
The FDA acknowledged positive efficacy from Vanda's controlled clinical trials but concluded the data did not provide substantial evidence of effectiveness, primarily because phase advance protocols were not considered sufficiently analogous to actual jet travel.
Vanda disagrees with the FDA's interpretation, maintaining that its submitted data meets the statutory standard for effectiveness and that phase advance models are valid surrogates for simulating jet lag.
This decision follows the D.C. Circuit setting aside a prior FDA refusal in August 2025, which led to a collaborative framework agreement with the FDA in October 2025 for an expedited re-review.
Vanda remains committed to pursuing approval for HETLIOZ® for jet lag disorder.

Jan 8, 2026, 12:00 PM

Press Release

Vanda Pharmaceuticals' Nereus Receives FDA Approval

VNDA

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

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.

Dec 30, 2025, 11:34 PM

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.

Dec 30, 2025, 11:13 PM

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.