A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Start Date21 Apr 2022

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT05352893

/ CompletedPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Start Date14 Apr 2022

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT04856930

/ CompletedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

Start Date07 Jul 2021

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

100 Clinical Results associated with Imsidolimab

100 Translational Medicine associated with Imsidolimab

100 Patents (Medical) associated with Imsidolimab

Literatures (Medical) associated with Imsidolimab

28 Apr 2026·NEJM evidence

Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis

Article

Author: Randazzo, Bruce ; Dahl, Martin ; Parmley, Stephen ; Lizzul, Paul ; Johnson, Caroline ; Birznieks, Gunther ; Brzezynski, Jennifer ; Tyner, Christina ; Bachelez, Hervé ; Polymeropoulos, Christos ; Bushman, Margaret ; Xiao, Changfu ; Gudjonsson, Johann E. ; Saikali, Khalil ; Polymeropoulos, Mihael ; Severtson, Anne ; Yap, Evelyn Wen Yee ; Denguezli, Mohamed ; Borlu, Murat ; Smieszek, Sandra ; Przychodzen, Bartlomiej ; Reich, Adam ; Raina, Priya ; Chaowattanapanit, Suteeraporn

BACKGROUND:

Generalized pustular psoriasis (GPP) is a rare, life-threatening disease attributed to aberrant interleukin-36 (IL-36) activity, often due to variants in the IL-36 receptor antagonist gene. Imsidolimab is a novel, humanized, affinity-matured immunoglobulin G4 monoclonal antibody that binds the IL-36 receptor and antagonizes IL-36 signaling.

METHODS:

Two phase 3 trials were conducted at 26 clinical sites within 11 countries investigating imsidolimab treatment for GPP. GEMINI-1 was a double-blind, placebo-controlled trial that randomly assigned 45 patients (18-80 years of age) with a GPP flare to receive either a single intravenous dose of 300 mg of imsidolimab, 750 mg of imsidolimab, or placebo. The primary endpoint was GPP Physician Global Assessment (GPPPGA) scores of clear (0) or almost clear (1) at week 4 (range: 0 [clear] to 4 [severe]; minimally clinically important difference, 1.4). GEMINI-2 was a follow-on relapse prevention trial with a primary objective of evaluating the safety of imsidolimab up to 104 weeks. Patients who improved with treatment in GEMINI-1 were randomly assigned to receive either 200 mg of subcutaneous imsidolimab or placebo monthly, whereas partial responders received open-label 200 mg of subcutaneous imsidolimab monthly.

RESULTS:

In GEMINI-1, 53% of patients in the groups that received either 300 mg (n=8/15) or 750 mg (n=8/15) of imsidolimab had GPPPGA scores of 0 or 1 at week 4, compared to 13% in the placebo group (n=2/15) (P=0.023 for both the 300 mg vs. placebo comparison and 750 mg vs. placebo comparison). In GEMINI-2, no serious adverse events led to imsidolimab discontinuation.

CONCLUSIONS:

Compared with placebo, a significantly higher proportion of patients with GPP randomly assigned to receive a single intravenous dose of imsidolimab were clear or almost clear of the disease after 4 weeks based on the GPPPGA. There were no serious adverse events that led to treatment discontinuation with imsidolimab up to 104 weeks of treatment. (Funded by AnaptysBio; ClinicalTrials.gov number, NCT05352893 for GEMINI-1 and NCT05366855 for GEMINI-2.).

01 May 2024·American journal of clinical dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

Author: Wu, Po-Chien ; Huang, Yu-Huei ; Huang, I-Hsin ; Chiu, Hsien-Yi

BACKGROUND:

The comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.

OBJECTIVE:

The aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.

METHODS:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.

RESULTS:

The study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.

CONCLUSION:

Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

01 Apr 2024·Journal of the American Academy of Dermatology

The expanding horizon of anti-IL-36 therapy

Author: Heymann, Warren R

A review.The IL-36 signaling pathway dermatol. revolution is underway.This pathway is key in the pathogenesis of generalized pustular psoriasis (GPP).The IL-36 receptor (IL-36R) antagonist spesolimab effectively manages GPP, rapidly controlling GPP flares and preventing their recurrence.A phase II trial of imsidolimab, a humanized IgG4 monoclonal antibody specifically binding IL-36R, demonstrated a rapid resolution of pustular eruptions in GPP patients.In this issue of the Journal of the American Academy of Dermatol. , the National Psoriasis Foundation asserts that 'GPP is a life-threatening disease that needs to be treated as quickly as possible'.A controversial point regarding spesolimab focuses on (whether) screening for tuberculosis should be performed when the drug has been prescribed.Ahmad et al state that 'IL-36 comprises 4 isoforms: the proinflammatory IL-36α, IL-36β, and IL-36γ, and the anti-inflammatory IL-36R antagonist.An imbalance between proinflammatory and anti-inflammatory IL-36 isoforms can contribute to the inflammatory fate of cells and tissues.Cutaneous IL-36 signaling is crucial for the immunopathol. outcome of various skin diseases.Consequently, the IL-36/IL-36R axis has recently been recognized as a promising drug target for the treatment of inflammatory disorders beyond psoriasis.A safe prediction is that IL-36 antagonists will be broadly used in medical dermatol. beyond the realm of GPP.

101

News (Medical) associated with Imsidolimab

21 Sep 2026

·www.biospace.com

Anaptys Announces Second Quarter and Transitional Fiscal Year 2026 Financial Results and Provides Business Update

Jemperli global net sales of $644 million (£480 million) for the six months ended June 30, 2026, representing 34% year-over-year growth Positive interim results from the pivotal AZUR-1 trial of Jemperli in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer announced in July; FDA PDUFA action date of February 2027 with eligibility for expedited review through the National Priority Voucher program, which could result in an earlier FDA decision Litigation with GSK and Tesaro: trial held in July; post-trial hearing scheduled for October 20, 2026, with a judgement anticipated in Q4 2026 or Q1 2027 SAN DIEGO, Sept. 21, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, today reported financial results for the second quarter and transitional fiscal year ended June 30, 2026, and provided a business update. “ Jemperli continues to demonstrate robust year-over-year growth with major catalysts within the next 6 months including further sales acceleration ex-US, anticipated FDA approval of Jemperli in monotherapy in dMMR/MSI-H neoadjuvant rectal cancer, as well as a judgement expected in our litigation with GSK and Tesaro,” said Daniel Faga, president and chief executive officer. “In addition to Jemperli , we anticipate FDA approval of Quimilza in GPP in December 2026.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli $331 million (£248 million) in global net sales for the three months ended June 30, 2026, representing 26% year-over-year growth 1 $644 million (£480 million) in global net sales for the six months ended June 30, 2026, representing 34% year-over-year growth 1 Anaptys continues to expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak monotherapy sales guidance of > $2.7 billion 2 Anaptys estimates Sagard will have accrued ~$301 million in royalties and sales milestones through Q2 2026 and anticipates paydown of the remaining ~$299 million non-recourse debt monetization in the second half of 2027 Jemperli development and regulatory updates include: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer In July 2026, GSK announced positive interim results from the trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months (cCR12) with no detectable signs of cancer for at least one year The FDA has assigned a PDUFA action date of February 2027 Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025; eligible for an expedited review which could result in an earlier FDA decision GSK to present first results from the AZUR-1 trial as a late-breaking abstract at ESMO Congress 2026 in Madrid, Spain on Oct. 25, 2026 AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer Data expected in 2028 AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer Primary completion date in Q4 2026 JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 CPS≥1) post chemoradiation Data expected in 2028 Vanda Quimilza (imsidolimab) Financial Collaboration FDA target action date (PDUFA) of Dec. 12, 2026, for Quimilza in generalized pustular psoriasis (GPP) In August 2026, Vanda announced it received Orphan Designation from the European Commission for imsidolimab for the treatment of GPP GSK and Tesaro Litigation Update The trial was held before the Delaware Chancery Court from July 14-17, 2026 The Court has requested the parties submit post-trial briefs in advance of a post-trial hearing, which has been scheduled for October 20, 2026 Anaptys filed its opening post-trial brief on August 21, 2026, GSK and Tesaro will answering post-trial brief on or before September 25, 2026, and Anaptys will reply post-trial brief on or before October 9, 2026 Anaptys is seeking reversion of Jemperli rights as a remedy; the Company anticipates a judgement in Q4 2026 or Q1 2027 Second Quarter Financial Results The separation of AnaptysBio and First Tracks Biotherapeutics was completed on April 20, 2026. Beginning in the second quarter of 2026, AnaptysBio reclassified historical First Tracks Biotherapeutics, Inc. related assets, liabilities and expenses as discontinued operations. On May 18, 2026, Anaptys changed its fiscal year-end from December 31 to June 30. The Company will begin to reports based on the new fiscal year beginning with the quarter ending September 30, 2026. As of June 30, 2026, Anaptys has not repurchased any shares under its $100 million Stock Repurchase Plan, which will expire on December 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock. Cash, cash equivalents and investments totaled $164.1 million as of June 30, 2026, compared to $211.6 million as of December 31, 2025, for a decrease of $47.5 million due primarily to $72.9 million for operating activities offset by $25.4 million received from stock option exercises. Collaboration revenue was $27.5 million and $53.0 million for the three and six months ended June 30, 2026, compared to $22.3 million and $50.0 million for the three and six months ended June 30, 2025. The increase is primarily due to Jemperli royalties increasing 25% and 34% for the three and six months ended June 30, 2026, offset by $9.7 million in revenue recognized for the Vanda license agreement for the three month and six months ended June 30, 2025. General and administrative expenses were $16.0 million and $23.4 million for the three and six months ended June 30, 2026, compared to $4.0 million and $8.3 million for the three and six months ended June 30, 2025. The increase was due primarily to legal costs for the separation of the company and the GSK and Tesaro lawsuit and non-cash stock compensation. Research and development expenses from continuing operations were a negative $2.7 million for the six months ended June 30, 2026, compared to a negative $1.7 million six months ended June 30, 2025. The negative balance for the six months ended June 30, 2026, was primarily due adjustments related to the closeout of clinical contracts reducing expenses incurred prior to the separation. Benefit for income taxes for continuing operations was $181.5 million for the six months ended June 30, 2026. The benefit recognized was primarily due to the release of the valuation allowance on deferred tax assets due to the anticipated usage of deferred tax assets in the future due to the separation from First Tracks Biotherapeutics. Net income from continuing operations was $177.3 million and $176.4 million for the three and six months ended June 30, 2026, or a basic net income per share of $6.06 and $6.09, compared to a net income from continuing operations of $5.7 million and $16.6 million for the three and six months ended June 30, 2025, or a basic net income per share of $0.20 and $0.56. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to future commercial and regulatory developments for Jemperli and Quimilza , future royalty amounts, the Company’s expected paydown of its obligations to Sagard, and the outcome of the Company’s ongoing litigation with GSK. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to commercial success of the Company’s licensed products, the company’s ability to protect its financial collaborations and return value to its shareholders, the company’s ability to operate efficiently with a limited staff, and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. About Anaptys Anaptys manages the financial collaborations for Jemperli with GSK and Quimilza with Vanda, with a focus on protecting and returning the value of its royalties to shareholders. To learn more, visit or follow us on LinkedIn . Contact: Chris Murphy Chief Financial Officer investors@anaptysbio.com _______________________________________ 1. GSK Q2 2026 earnings call, 7/28/2026 2. CEO Emma Walmsley, 2025 JP Morgan CEO Series fireside chat, 9/11/2025, “there's no change to our peak year sales overall ambition for Jemperli , that's for sure, which is far more than £2 billion.”; Converted from GBP to USD using Q3 2025 average exchange rate (1.35x) AnaptysBio, Inc. Consolidated Balance Sheets (in thousands, except par value data) June 30, 2026 December 31, 2025 ASSETS Current assets: Cash and cash equivalents $ 133,826 $ 138,196 Receivables from collaborative partners 25,634 33,850 Short-term investments 30,317 73,442 Prepaid expenses and other current assets 8,650 — Current assets of discontinued operations — 104,762 Total current assets 198,427 350,250 Property and equipment, net 102 111 Deferred tax asset 106,639 — Operating lease right-of-use assets 11,560 12,519 Other long-term assets 256 256 Non-current assets of discontinued operations — 1,259 Total assets $ 316,984 $ 364,395 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities: Accounts payable $ 4,394 $ 3,871 Accrued expenses 28,798 32,674 Current portion of operating lease liability 2,161 2,080 Total current liabilities 35,353 38,625 Liability related to sale of future royalties 256,493 276,528 Long-term taxes payable 3,619 — Operating lease liability, net of current portion 10,934 12,032 Stockholders’ equity: Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at June 30, 2026 and December 31, 2025, respectively — — Common stock, $0.001 par value, 500,000 shares authorized, 29,728 shares and 28,019 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 30 28 Additional paid in capital 652,269 809,765 Accumulated other comprehensive loss (151 ) (24 ) Accumulated deficit (641,563 ) (772,559 ) Total stockholders’ equity 10,585 37,210 Total liabilities and stockholders’ equity $ 316,984 $ 364,395 AnaptysBio, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 (unaudited) 2025 (unaudited) 2026 2025 (unaudited) Collaboration revenue $ 27,488 $ 22,263 $ 53,044 $ 50,034 Operating expenses: Research and development (2,704 ) (1,448 ) (2,668 ) (1,733 ) General and administrative 16,044 3,984 23,390 8,298 Total operating expenses 13,340 2,536 20,722 6,565 Income from operations 14,148 19,727 32,322 43,469 Other income (expense), net: Interest income 1,486 2,102 3,252 5,402 Sublease income 526 — 526 — Non-cash interest expense for the sale of future royalties (20,333 ) (19,606 ) (41,192 ) (37,667 ) Other (expense) income, net (1 ) 3,544 (1 ) 5,453 Total other expense, net (18,322 ) (13,960 ) (37,415 ) (26,812 ) (Loss) income before income taxes (4,174 ) 5,767 (5,093 ) 16,657 Benefit (provision) for income taxes 181,491 (39 ) 181,451 (83 ) Income from continuing operations 177,317 5,728 176,358 16,574 Income (loss) from discontinued operations, net of tax 6,563 (44,358 ) (45,362 ) (94,533 ) Net income (loss) 183,880 (38,630 ) 130,996 (77,959 ) Other comprehensive (loss) income: Unrealized loss on available for sale securities (5 ) (167 ) (127 ) (311 ) Comprehensive income (loss) $ 183,875 $ (38,797 ) $ 130,869 $ (78,270 ) Net income (loss) per common share: Income from continuing operations - basic $ 6.06 $ 0.20 $ 6.09 $ 0.56 Income (loss) from discontinued operations - basic $ 0.22 $ (1.54 ) $ (1.57 ) $ (3.18 ) Net income (loss) per common share - basic $ 6.28 $ (1.34 ) $ 4.52 $ (2.62 ) Income from continuing operations - diluted $ 4.93 $ 0.19 $ 4.71 $ 0.54 Income (loss) from discontinued operations - diluted $ 0.18 $ (1.49 ) $ (1.21 ) $ (3.08 ) Net income (loss) per common share - diluted $ 5.11 $ (1.30 ) $ 3.50 $ (2.54 ) Weighted-average number of shares outstanding: Basic 29,264 28,810 28,979 29,722 Diluted 35,975 29,806 37,476 30,692

Phase 3Clinical ResultDrug ApprovalFinancial StatementBreakthrough Therapy

24 Aug 2026

·www.prnewswire.com

Vanda Pharmaceuticals Granted Orphan Designation for Imsidolimab for the Treatment of Generalized Pustular Psoriasis by the European Commission

WASHINGTON, Aug. 24, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that its investigational drug imsidolimab has received Orphan Designation from the European Commission, based on the positive opinion received from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of Generalized Pustular Psoriasis (GPP), which is a severe, chronic, and potentially life-threatening inflammatory skin disease driven by dysregulation in the interleukin-36 (IL-36) signaling pathway.1 The US Food and Drug Administration (FDA) and Japan's Ministry of Health, Labour and Welfare have previously granted Orphan Drug Designation to imsidolimab for the treatment of GPP. This marks the first time the European Commission has granted orphan designation recognition for a drug to treat GPP in the European Union (EU). GPP is clinically distinct from plaque psoriasis and is characterized by widespread pustular eruptions, systemic inflammation, and serious complications that can lead to increased mortality.2,3,4 Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36 receptor antagonist commonly observed in patients with GPP. Orphan Designation in the EU is granted by the European Commission following an opinion from EMA's COMP for medicines intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating rare conditions. Among other criteria, the condition must affect fewer than 5 in 10,000 people in the EU. Benefits include protocol assistance, reduced regulatory fees, and market exclusivity provisions in the EU following approval. "The European Commission's Orphan Designation for imsidolimab represents an important milestone for the GPP community and for our efforts to bring this investigational therapy to patients in Europe," said Dr. Mihael H. Polymeropoulos, Vanda's President, CEO and Chairman of the Board. "With orphan designations now received in Europe, the United States and Japan, we remain focused on advancing imsidolimab for patients in these markets who need new treatment options." This designation follows similar regulatory recognitions in the United States and Japan. Additionally, the imsidolimab Biologics License Application (BLA) for GPP is currently under review by the FDA with a target action date of December 12, 2026. References Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). Ministry of Health Labour and Welfare (MHLW), "Pustular psoriasis (generalized type) (Designated Intractable Disease 37)," Japan Intractable Diseases Information Center. Accessed: Mar. 10, 2026. [Online]. Available: H. Fujita, R. Iwasaki, S. Tsuboi, Y. Murashiuma, and M. Akiyama, "Regional differences in the prevalence of generalized pustular psoriasis in Japan," J. Dermatol., vol. 51, no. 3, pp. 380–390, Mar. 2024, doi: 10.1111/1346-8138.17089. H. Miyachi et al., "Treatments and outcomes of generalized pustular psoriasis: A cohort of 1516 patients in a nationwide inpatient database in Japan," J. Am. Acad. Dermatol., vol. 86, no. 6, pp. 1266–1274, Jun. 2022, doi: 10.1016/j.jaad.2021.06.008. 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. About Vanda Pharmaceuticals Inc. 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 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 potential benefits associated with EMA approval of an orphan drug, the therapeutic potential of imsidolimab for patients with GPP in the EU, the United States and Japan, and the anticipated timing of the completion of the FDA's review of the imsidolimab BLA 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, Vanda's ability to obtain approval of, and to successfully commercialize, imsidolimab in the EU, the United States and Japan for the treatment of patients with GPP, Vanda's ability to satisfy the conditions necessary to receive the benefits associated with EMA approval of an orphan drug, and the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026. 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 . 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 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

Orphan DrugLicense out/in

05 Aug 2026

·www.prnewswire.com

Vanda Pharmaceuticals Reports Second Quarter 2026 Financial Results

Fanapt® Q2 2026 net product sales increased 23% to $36.0 million; total prescriptions increased 31% Full-year 2026 total revenue guidance of $240-$290 million Cash totaled $170.0 million as of June 30, 2026; expected to fund operations through at least the end of 2027 BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia in Q1 2026; commercial launch expected in second half of 2026 Quimilza™ (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026 NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026 Results for three Phase III clinical trials expected by end of 2026: NEREUS™ (tradipitant) in vomiting in GLP-1, VQW-765 in social anxiety disorder HETLIOZ® (tasimelteon) in delayed sleep phase disorder WASHINGTON, Aug. 5, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2026. "We are pleased with the continued strong growth of Fanapt and the enthusiastic early response to NEREUS as it becomes available to patients. With BYSANTI approved and on track for launch in the second half of 2026, a December 2026 PDUFA date for Quimilza and multiple late-stage clinical trial results expected before year-end, we believe Vanda is well positioned for meaningful commercial expansion and pipeline value creation," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "As our Phase III programs, launch preparations, and commercial supply manufacturing near completion, we expect operating expenses to begin moderating later this year and more significantly in 2027. Our current resources, together with anticipated product revenues, provide a solid foundation to advance our objectives through at least the end of 2027." Financial Highlights During 2025 and 2026, we have advanced multiple Phase III programs, continued execution on the commercialization of Fanapt® (iloperidone) and PONVORY® (ponesimod) and prepared for the commercial launches, including manufacturing commercial supplies, of NEREUS™ (tradipitant), BYSANTI™ (milsaperidone), and Quimilza™ (imsidolimab). These activities resulted in significantly increased operating expenses in 2025 and 2026. As these activities conclude, Vanda expects operating expenses to begin decreasing by the end of 2026 and more substantially throughout 2027. Based on its current cash position and anticipated revenues, Vanda expects to have sufficient resources to fund operations through at least the end of 2027. Second Quarter of 2026 Total net product sales were $50.5 million in Q2 2026, a 4% decrease compared to $52.6 million in Q2 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Fanapt® net product sales were $36.0 million in Q2 2026, up 23% year-over-year. HETLIOZ® (tasimelteon) net product sales were $5.6 million in Q2 2026, down 66% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026. PONVORY® net product sales were $7.9 million in Q2 2026, up 12% year-over-year. NEREUSTM net product sales were $1.0 million in Q2 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Loss before income taxes was $62.4 million in Q2 2026 compared with $34.9 million in Q2 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $32.3 million in Q2 2026. First Six Months of 2026 Total net product sales were $102.2 million in the first six months of 2026 as compared to $102.6 million in the first six months of 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026. Fanapt® net product sales were $65.5 million in the first six months of 2026, up 24% year-over-year. HETLIOZ® net product sales were $21.5 million in the first six months of 2026, down 42% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026. PONVORY® net product sales were $14.1 million in the first six months of 2026, up 11% year-over-year. NEREUSTM net product sales were $1.0 million in the first six months of 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Loss before income taxes was $110.8 million in the first six months of 2026 compared with $72.3 million in the first six months of 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $93.8 million compared to December 31, 2025. Key Commercial Highlights Fanapt® saw continued strong momentum in Q2 2026, with total prescriptions (TRx)1 up 31% and new-to-brand prescriptions (NBRx)1 up 32% versus Q2 2025. Since commercial expansion following the approval of bipolar disorder, Fanapt® has seen significant growth, with TRx1 up 62% and NBRx1 up 300% versus Q2 2024. BYSANTI™ received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia in Q1 2026 and is expected to launch in the second half of 2026. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. In May 2026, the early commercial launch of NEREUS™ was initiated with a direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026. Key Regulatory & Clinical Development Highlights Upcoming Clinical Milestones Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected in 2026. The Phase III study of HETLIOZ® in the treatment of delayed sleep phase disorder (DSPD), with results expected in 2026. The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in the first half of 2027. Other Updates The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2. In May 2026, Vanda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation to Quimilza™ for the treatment of GPP. In July 2026, Vanda announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) had adopted a positive opinion recommending orphan drug designation for Quimilza™ for the treatment of GPP. In July 2026, Vanda announced that the FDA had granted Rare Pediatric Disease Designation to VCA-894A, Vanda's investigational antisense oligonucleotide therapy for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), a rare, serious, and progressive inherited neurological disorder. Vanda continues to progress the FDA formal hearing regarding HETLIOZ® for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the D.C. Circuit set aside the FDA's prior refusal to approve the application, is advancing according to schedule and is expected to culminate in a five-day hearing before the Administrative Law Judge in December 2026. GAAP Financial Results Net loss was $62.5 million (diluted loss per share of $1.04) in Q2 2026 compared with a net loss of $27.2 million (diluted loss per share of $0.46) in Q2 2025. Net loss was $111.1 million (diluted loss per share of $1.86) in the first six months of 2026 compared with a net loss of $56.7 million (diluted loss per share of $0.96) in the first six months of 2025. 2026 Financial Guidance Vanda is reiterating its 2026 total revenue guidance and expects to achieve the following financial objectives in 2026: Conference Call Vanda has scheduled a conference call for today, Wednesday, August 5, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the second quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 1843107. A replay of the call will be available on Wednesday, August 5, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, August 12, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 1843107. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About Vanda Pharmaceuticals Inc. 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 and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's expectations with respect to its ability to fund its operations through at least the end of 2027; the expected timing of the commercial launch of BYSANTI™ for the treatment of bipolar I disorder and schizophrenia; the anticipated timing of the completion of the FDA's review of the Quimilza™ BLA for the treatment of GPP; Vanda's clinical development plans and expected timelines for NEREUS™ in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, HETLIOZ® in the treatment of DSPD, and BYSANTI™ for the treatment of MDD; Vanda's expectations with respect to its commercial expansion and ability to create value from its product pipeline; Vanda's expectations with respect to its operating expense run rate through 2027; the anticipated timing of the commencement of personal promotion of NEREUS™; Vanda's continued pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder and Vanda's expectations with respect to the HETLIOZ® evidentiary hearing; and Vanda's expectations with respect to the strength of its business 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, Vanda's ability to continue to grow its business; Vanda's ability to reduce its operating expenses, conserve cash and generate enough revenue to fund its operations through at least the end of 2027; Vanda's ability to successfully execute the commercial launch of BYSANTI™ for the treatments of bipolar I disorder and schizophrenia in the second half of 2026; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for Quimilza™ by December 12, 2026; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the Phase III studies for NEREUS™ in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, and HETLIOZ® in the treatment of DSPD and receive the respective study results by the end of 2026; Vanda's ability to complete the Phase III study for BYSANTI™ for the treatment of MDD and receive results in the first half of 2027; Vanda's ability to commence personal promotion of NEREUS™ for the prevention of vomiting induced by motion in 2026; and the outcome of the administrative hearing process for HETLIOZ® for the treatment of jet lag disorder. 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 . 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 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

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100 Deals associated with Imsidolimab

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized Pustular Psoriasis	NDA/BLA	United States	Vanda Pharmaceuticals, Inc.	17 Dec 2025
Hidradenitis Suppurativa	Phase 2	United States	AnaptysBio, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	United States	Vanda Pharmaceuticals, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	Canada	AnaptysBio, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	Canada	Vanda Pharmaceuticals, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	Georgia	AnaptysBio, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	Poland	AnaptysBio, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	Poland	Vanda Pharmaceuticals, Inc.	07 Jul 2021
Acne Vulgaris	Phase 2	United States	Vanda Pharmaceuticals, Inc.	15 May 2021
Acne Vulgaris	Phase 2	Canada	Vanda Pharmaceuticals, Inc.	15 May 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05352893 \| NCT05366855 (GEMINI-2, Pubmed \| NEJM Evid)	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab 300 mg	itrchosjln(qmopeqqaug) = rdpbwfutah xxblovgcje (qhbkfeanxf )	Positive	28 Apr 2026
				Imsidolimab 750 mg	itrchosjln(qmopeqqaug) = pfclurlmws xxblovgcje (qhbkfeanxf )
NCT05366855 (GEMINI-2, CTgov)	Phase 3	Generalized Pustular Psoriasis	42	imsidol (ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC)	jwcbjweehh = xnsxdpkwlj pligdmhxbc (sggbdouwvb, kzugfkdqoe - mwnhovxstc) View more	-	27 Mar 2026
				Placebo (ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC)	jwcbjweehh = jpkbuskubt pligdmhxbc (sggbdouwvb, vsmocrzveu - xskpciixhp) View more
NCT05352893 (GEMINI1 \| GEMINI-1, CTgov)	Phase 3	Generalized Pustular Psoriasis	45	Placebo	yhsrouiypv = ubjenwtaks zddrshfagt (awbwtgtqzo, ejekrdznds - fieculzpyw) View more	-	17 Mar 2026
NCT04856930 (CTgov)	Phase 2	Hidradenitis Suppurativa	149	Imsidolimab (Placebo-Controlled Period: Imsidolimab 400/200 mg)	benykigmnk(hfsvnlcpcn) = zfruxpuflz kfqrbdqdyp (jqyhjrltdi, 6.05) View more	-	22 Sep 2025
				Imsidolimab (Placebo-Controlled Period: Imsidolimab 200/100 mg)	benykigmnk(hfsvnlcpcn) = jmwmfwvidn kfqrbdqdyp (jqyhjrltdi, 4.63) View more
NCT05366855 (GEMINI-2, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis Maintenance	16	imsidolimab (GEMINI-2 + GPPPGA 0/1 responder patients from GEMINI-1)	vdstixsbnf(dewqpiykaa) = lwddtiatio difdyftrkf (oajvxuuwzk )	Positive	09 May 2024
NCT05352893 (GEMINI1, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab 750mg (GEMINI-1)	ecmwqgzzjx(lieuokdcrz) = auabtlsjpu gisfqjcvxe (oahghqxwex )	Positive	09 May 2024
				Imsidolimab 300mg (GEMINI-1)	ecmwqgzzjx(lieuokdcrz) = rdpahclraq gisfqjcvxe (oahghqxwex )
NCT05352893 (GEMINI1, Corporate Publications) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab	pngbmvoyxb(nyvtdzzfgh) = vyidddmbvu wkzkvoidac (hppusyezxj ) Met View more	Positive	09 Oct 2023
				Placebo	pngbmvoyxb(nyvtdzzfgh) = strkaxcfdr wkzkvoidac (hppusyezxj ) Met
NCT04856917 (CTgov)	Phase 2	Acne Vulgaris	123	Imsidolimab (Imsidolimab 400/200 mg)	vhafhxsypx(qzezzhtaol) = htraupuhkc ulvxrrzfnz (vrfezkqikz, 13.63) View more	-	15 Jun 2023
				Imsidolimab (Imsidolimab 200/100 mg)	vhafhxsypx(qzezzhtaol) = iljdhspprv ulvxrrzfnz (vrfezkqikz, 16.38) View more
NCT04697056 (CTgov)	Phase 2	Ichthyosis	5	Imsidolimab (Imsidolimab)	odfgvaiioe = phiotqxfvl jfavxalskd (mkycnjqaxy, kxmzadonmd - weeykyiwci) View more	-	02 Mar 2023
				placebo (Placebo)	odfgvaiioe = gwaiuoobcp jfavxalskd (mkycnjqaxy, griklvgoir - ggyrklqygt) View more
NCT03633396 (POPLAR, CTgov)	Phase 2	Pustulosis of Palms and Soles	59	Placebo (Placebo)	jsehaplhru(bxruvftirl) = xtpgoggyxm qeferknist (eeajruyzgf, 1.48) View more	-	31 May 2022
				Imsidolimab (Imsidolimab)	jsehaplhru(bxruvftirl) = jnmehitddo qeferknist (eeajruyzgf, 1.46) View more

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