Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) announced FDA acceptance of its Biologics License Application for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.

Pivotal GEMINI-1/2 studies showed 53% achieving GPPPGA 0/1 at Week 4 versus 13% placebo; efficacy maintained during ~2-year monthly maintenance, with a favorable safety profile and low anti-drug antibodies.

Positive

• BLA accepted with FDA target action date Dec 12, 2026
• Pivotal trials: 53% achieved GPPPGA 0/1 at Week 4 versus 13% placebo
• Efficacy sustained during an approximately 2-year maintenance period with no flares
• Favorable safety profile with low incidence of anti-drug antibodies

Negative

• GPP prevalence is small and variable (2–124 cases per million), limiting patient population visibility

Key Figures

FDA target action date: December 12, 2026 Week 4 response rate: 53% GPPPGA 0/1 Placebo response rate: 13% GPPPGA 0/1 +3 more

6 metrics

FDA target action date December 12, 2026 BLA for imsidolimab in GPP

Week 4 response rate 53% GPPPGA 0/1 Imsidolimab-treated patients in GEMINI-1 and GEMINI-2

Placebo response rate 13% GPPPGA 0/1 Placebo arm at Week 4 in GEMINI studies

Maintenance duration Approximately 2-year period Efficacy maintained with monthly dosing

GPP prevalence (low end) 2 cases per million Lower estimate, mainly in Europe

GPP prevalence (high end) 124 cases per million Higher estimate, parts of Asia

Market Reality Check

Price: $55.41 Vol: Volume 228,191 is at 0.5x...

low vol

$55.41 Last Close

Volume Volume 228,191 is at 0.5x the 20-day average of 460,693, indicating muted trading interest pre-announcement. low

Technical Price at $55.41, trading above 200-day MA $32.62, 4.04% below 52-week high $57.74 and 296.07% above 52-week low $13.99.

Peers on Argus

While ANAB was up 2.06%, momentum scanner peers IMTX, PVLA and SVRA were all dow...

3 Down

While ANAB was up 2.06%, momentum scanner peers IMTX, PVLA and SVRA were all down (median move about -1.8%), pointing to stock-specific strength versus a weaker biotech peer group.

Historical Context

5 past events · Latest: Feb 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 05	Investor conferences	Neutral	-1.0%	Management announced participation in multiple upcoming investor conferences.
Jan 08	Litigation update	Neutral	+2.0%	Company filed motion to dismiss a contractual claim in ongoing litigation.
Jan 06	Investor conference	Neutral	+1.6%	CEO scheduled to present at the J.P. Morgan Healthcare Conference.
Dec 15	Regulatory milestone	Positive	+1.4%	Vanda submitted a BLA to the FDA for imsidolimab to treat GPP.
Nov 25	Investor conferences	Neutral	+1.6%	Executives planned fireside chats and 1x1s at December healthcare conferences.

Pattern Detected

Recent ANAB headlines, mostly conference and procedural items, have tended to coincide with modest positive or mildly negative price moves, showing generally aligned reactions to neutral-to-positive news.

Recent Company History

Over the past few months, ANAB’s news flow has focused on investor outreach and procedural updates. Several releases highlighted participation in major healthcare and investor conferences, with modest price moves of between about -0.99% and +1.64%. One item concerned litigation procedure, which also saw a small positive reaction. The only directly related prior Vanda item in this history was the earlier BLA submission for imsidolimab, which drew a +1.38% move, indicating that regulatory milestones around this asset have previously been received positively.

Market Pulse Summary

This announcement highlights FDA acceptance of the BLA for imsidolimab in generalized pustular psori...

Analysis

This announcement highlights FDA acceptance of the BLA for imsidolimab in generalized pustular psoriasis, with a target action date of December 12, 2026. Pivotal data showed a 53% Week 4 response rate versus 13% on placebo and maintenance over about 2 years of dosing, addressing a rare, severe disease. In context of ANAB’s recent news history, investors may focus on regulatory review progress, future commercialization updates, and any further clinical data readouts.

Key Terms

biologics license application, anti-drug antibodies, precision medicine

3 terms

biologics license application regulatory

"FDA has accepted the filing of its Biologics License Application (BLA) for imsidolimab"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

anti-drug antibodies medical

"Imsidolimab exhibited a favorable safety profile and demonstrated a low incidence of anti-drug antibodies"

Anti-drug antibodies are immune system proteins that form in patients in response to a biological therapy, such as a therapeutic protein or antibody, and can bind to the medicine. They matter to investors because they can reduce or eliminate a drug’s effectiveness, create safety problems, force higher dosing or additional testing, and influence regulatory approval and commercial success — like delivery guards accidentally intercepting and stopping a needed package.

precision medicine medical

"Imsidolimab represents a precision medicine approach targeting a disorder with a known genetic cause"

Precision medicine uses a person’s unique genetic makeup, lifestyle and environment to choose treatments and preventive steps that are more likely to work for them than one-size-fits-all approaches. For investors, it matters because it can make therapies more effective and efficient—think tailoring a suit rather than buying off the rack—affecting drug development costs, market size, pricing power and the speed at which therapies win regulatory approval.

AI-generated analysis. Not financial advice.

WASHINGTON, Feb. 25, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.

GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms such as fever and fatigue. The pathogenesis of GPP is increasingly understood through its genetic characterization (OMIM #614204), and its molecular etiology is mainly attributed to excessive activity of the interleukin-36 (IL-36) pathway.¹ The majority of GPP cases for which a causal single gene defect has been identified are caused by various consequential genetic variants in the IL36RN gene, encoding the IL-36 receptor antagonist (IL-36Ra).^2,3,4

Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is believed to achieve its therapeutic effects in GPP where IL-36 signaling is unbalanced. If approved, imsidolimab could address a significant unmet medical need in this rare and life-threatening disorder with potential benefits over currently existing treatments.

Imsidolimab was studied in global clinical studies conducted in the United States, France, Spain, Poland, Turkey, Malaysia, Thailand, Georgia, Tunisia, Taiwan, and Morocco. In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin (GPPPGA 0/1) at Week 4 compared to 13% on placebo. Efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm. Imsidolimab exhibited a favorable safety profile and demonstrated a low incidence of anti-drug antibodies, which can be a significant advantage over existing treatments. GPP is a rare disorder with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide (lower in Europe and higher in parts of Asia).^5,6

"The acceptance of the BLA filing for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "Imsidolimab builds on our growing expertise in rare orphan disorders and our anti-inflammatory portfolio. Imsidolimab represents a precision medicine approach targeting a disorder with a known genetic cause using a fully humanized monoclonal antibody against the IL-36 receptor. We look forward to potential FDA approval and leveraging our commercial infrastructure to address this debilitating condition."

Vanda celebrates this significant milestone for imsidolimab's acceptance for review by the FDA during Rare Disease Week on Capitol Hill (February 24–26, 2026), as advocates unite to promote innovation and access to treatments for rare orphan diseases like generalized pustular psoriasis.

If imsidolimab is approved, it will be the third new drug product approved for Vanda in the past 12 months, following NEREUS™ (tradipitant) and BYSANTI™ (milsaperidone).

References

1. Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 614204: 12/16/2020. Available at: https://omim.org/
2. Marrakchi, S. et al. Interleukin-36–Receptor Antagonist Deficiency and Generalized Pustular Psoriasis. New England Journal of Medicine 365, 620–628 (2011).
3. Sugiura, K. et al. The Majority of Generalized Pustular Psoriasis without Psoriasis Vulgaris Is Caused by Deficiency of Interleukin-36 Receptor Antagonist. Journal of Investigative Dermatology 133, 2514–2521 (2013).
4. Johnston, A. et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. Journal of Allergy and Clinical Immunology 140(1), 109–120 (2017).
5. Sachen, K. L. et al. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022).
6. Prinz, J. C. et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal of the European Academy of Dermatology and Venereology 37, 256–273 (2022).

About Imsidolimab

Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of imsidolimab from AnaptysBio (Nasdaq: ANAB).

About Vanda Pharmaceuticals

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this press release, including, but not limited to statements regarding the anticipated timing of the completion of the FDA's review of the imsidolimab BLA; imsidolimab's mechanism of action; the potential for imsidolimab to address a significant unmet medical need; the prevalence of GPP; potential FDA approval  of imsidolimab; Vanda's plans to leverage its commercial infrastructure to address GPP; and the potential to extend regulatory and patent exclusivity for imsidolimab into the late 2030s, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's assumptions regarding how imsidolimab achieves its therapeutic effect; Vanda's ability to obtain FDA approval of imsidolimab for the treatment of GPP; Vanda's ability to successfully execute the commercial launch of imsidolimab and to leverage its commercial infrastructure to reach patients with GPP; the ability of imsidolimab to safely and effectively treat GPP; the accuracy of the estimates of the prevalence of GPP; and Vanda's ability to satisfy the conditions necessary to extend regulatory and patent exclusivity for imsidolimab into the late 2030s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

What did Vanda (VNDA) announce about imsidolimab on February 25, 2026?

Vanda announced FDA acceptance of the BLA for imsidolimab, setting a target action date of December 12, 2026. According to the company, this advances regulatory review for GPP treatment and begins the FDA decision timeline.

How effective was imsidolimab in GEMINI-1 and GEMINI-2 trials reported by Vanda (VNDA)?

Imsidolimab achieved 53% clear/almost clear skin (GPPPGA 0/1) at Week 4 versus 13% for placebo. According to the company, efficacy was rapid and maintained during roughly two years of monthly dosing.

What safety and immunogenicity results did Vanda (VNDA) report for imsidolimab?

Vanda reported a favorable safety profile and a low incidence of anti-drug antibodies for imsidolimab. According to the company, low immunogenicity may offer an advantage over some existing treatments.

When is the FDA decision expected for imsidolimab according to Vanda (VNDA)?

The FDA target action date for imsidolimab is December 12, 2026. According to the company, that date marks the regulatory milestone for potential approval of the GPP therapy.

What was the duration of maintenance efficacy for imsidolimab in Vanda's (VNDA) studies?

Efficacy was maintained through an approximately 2-year maintenance period with monthly dosing, with no flares reported in the active arm. According to the company, this suggests durable control in trial patients.

How common is generalized pustular psoriasis and what does Vanda (VNDA) report about prevalence?

Vanda reports GPP prevalence estimates range from about 2 to 124 cases per million worldwide. According to the company, prevalence varies by region, indicating a rare and geographically variable patient population.