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

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.

17 Jul 2023·The British journal of dermatology

Imsidolimab: an emerging biological therapy for generalized pustular psoriasis

Communications

Author: Gleeson, David ; Mahil, Satveer K

Journal Article Corrected proof Imsidolimab: an emerging biological therapy for generalized pustular psoriasis Get access David Gleeson, David Gleeson St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK https://orcid.org/0000-0002-7355-9281 Search for other works by this author on: Oxford Academic Google Scholar Satveer K Mahil Satveer K Mahil St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK Corresponding author: Satveer Mahil. Email: satveer.mahil@kcl.ac.uk https://orcid.org/0000-0003-4692-3794 Search for other works by this author on: Oxford Academic Google Scholar British Journal of Dermatology, ljad128, https://doi-org.libproxy1.nus.edu.sg/10.1093/bjd/ljad128 Published: 20 April 2023 Article history Received: 13 April 2023 Accepted: 13 April 2023 Published: 20 April 2023 Corrected and typeset: 22 May 2023

News (Medical) associated with Imsidolimab

15 May 2026

·endpoints.news

Andrea Pfeifer ends 23-year reign at AC Immune; Acadia's top R&D exec announces retirement

AC Immune will be searching for a new CEO for the first time, as the company announced this week that Andrea Pfeifer plans to retire after 23 years at the helm. Pfeifer co-founded AC Immune back in 2003 and steered the biotech to an IPO in 2016. Since then, AC Immune has been no stranger to big pharma partnerships and had its fair share of controversies. Most notably, the biotech partnered with Roche and Genentech on the Alzheimer’s drug crenezuamab , which failed two Phase 3 studies for prodromal Alzheimer’s in the mid 2010s. In 2022, the companies followed up with a Phase 2 miss in Alzheimer’s prevention — though AC Immune tried to spin it positively anyway. Roche terminated the partnership in 2024. For some of AC Immune’s wholly owned programs, it was similarly contentious. The biotech bragged in 2021 that it had “remarkable” and “unprecedented” results on an Alzheimer’s vaccine, but didn’t disclose any specific data, and the results came from a trial with just 32 patients. AC Immune is teamed up with Johnson & Johnson on the program, but enrollment in a new trial was paused earlier this year. Pfeifer’s retirement comes after the company trimmed its pipeline and laid off 30% of its staff last September in a bid to extend its runway into 2027. Martin Zügel , AC Immune’s board chair, will serve as interim CEO while the search for a new chief proceeds. — Max Gelman → Acadia Pharmaceuticals R&D chief Elizabeth Thompson will retire at the end of the year, and the commercial biotech is looking for her replacement. Thompson had led R&D at Horizon Therapeutics — sticking around for a bit at Amgen when the buyout was completed — and joined Acadia in the spring of 2024. Phase 2 results are on deck this year for Acadia’s 5HT2A receptor inverse agonist remlifanserin in patients with Alzheimer’s disease psychosis. In December, the FDA approved a strawberry-flavored powder formulation of Acadia’s Rett syndrome treatment Daybue . “Leading Acadia’s research and development organization has been a defining chapter in my career and one in which I take a great deal of pride,” Thompson said in a statement , adding, “I am particularly pleased with how we’ve been able to strengthen the remlifanserin program, especially by expanding it into Lewy body dementia psychosis.” → AnaptysBio has tapped Chris Murphy as CFO and welcomed XOMA Royalty CEO Owen Hughes to the board of directors. Murphy and CEO Daniel Faga are a two-man executive team as Anaptys concentrates on “royalty streams” from its partnerships with GSK ( Jemperli ) and Vanda Pharmaceuticals ( imsidolimab ). Anaptys’ spinoff First Tracks Biotherapeutics handles the rest of the pipeline. Murphy is another Horizon vet and was elevated to group VP, commercial operations, market access and analytics at the end of a six-year run with the company. He also popped up in Peer Review when he became chief financial and business officer at the now-shuttered Third Harmonic Bio . → It’s hard to give up any spot at the world’s most valuable pharmaceutical company, but Eli Lilly ’s executive director for its obesity commercial strategy in the US employer market is leaving after 23 years at the pharma giant. Dennis O’Brien wrote on LinkedIn that it was “time to move on.” → After the FDA rejected Replimune ’s oncolytic virus therapy once again, its chief commercial officer is moving on. Chris Sarchi is taking the same role at Bicara Therapeutics , a public biotech that is studying a monoclonal antibody called ficerafusp alfa in recurrent or metastatic, HPV-negative head and neck squamous cell carcinoma. Bicara has also promoted Bill Schelman to CMO as David Raben slides into an advisory post. Schelman had led clinical development at Bicara for the past eight months, and the Hutchmed vet jumped to industry at Eli Lilly in the 2010s. → Flagship Pioneering has hired Nathan Jorgensen as a growth partner after we informed you last week about his departure from Voyager Therapeutics . Former Exact Sciences and binx health CEO Jeffrey Luber is also on board in the same capacity. Jorgensen spent nearly two years with Voyager as CFO and held that position at Vor Bio from 2020-24. → Verastem Oncology said in its Q1 report that Daniel Lyons had joined the team as chief commercial officer. Lyons was promoted to SVP, head of rare tumors international and global head of market access at SpringWorks Therapeutics , which had two products cross the regulatory finish line before it was sold to Merck KGaA : Ogsiveo for desmoid tumors and Gomekli for neurofibromatosis type 1. Last year at this time, the FDA approved Verastem’s Avmapki Fakzynja Co-Pack for certain ovarian cancer patients. → Now led by former Five Prime CEO Tom Civik on an interim basis, Pyxis Oncology has brought in Nelson Azoulay as CBO. Azoulay had been SVP, strategy and business development for Flagship since November 2024, and he oversaw corporate development at ImmunoGen at the time of its $10 billion exit to AbbVie . Like the ovarian cancer drug at the heart of the ImmunoGen buyout, Pyxis’ lead asset micvotabart pelidotin is an antibody-drug conjugate for head and neck squamous cell carcinoma. → Edward Rebar has been named CSO of CPTx , a German in vivo CAR-T developer using single-stranded DNA (ssDNA) in the hopes that it leads to less toxicity. Rebar had a 22-year career at Sangamo and was chief technology officer at Sana Biotechnology from 2020-24. Meanwhile, CPTx has promoted David Maier to CBO after he served as president of its ssDNA manufacturing unit called gxstrands . → It’s been a minute since Srikanth Pendyala has shown up in Peer Review. We mentioned him in 2021, when he was named CMO of Endeavor BioMedicines . Pendyala left the fibrosis drug developer in 2023 to become CMO at a stealth company, according to his LinkedIn. It’s unclear what that three-year period entailed, but he’s reemerged to lead the IL-22 and IL-13 antibodies at Merck- partnered Infinimmune as medical chief. “After 25 years of developing immunology therapeutics, it’s clear that the drugs that work best in patients tend to resemble what the human immune system already makes,” Pendyala said in a statement . → Donn Casale will become president of neffy maker ARS Pharmaceuticals on June 1. This is the second move involving a Dynavax vet this month after the appointment of Andrew Davis as CBO of Convergent Therapeutics . Casale was promoted to chief commercial officer at Dynavax in 2023 and still held that job title when Sanofi bought the vaccine maker for $2.2 billion. → Septerna said in a quarterly update this week that medical chief Jae Kim is leaving for a job located “near his primary residence” in Southern California. The Bay Area biotech has started a search for his successor. Kim came to Septerna in 2024 after brief stints in the CMO role at Design Therapeutics and Avidity Biosciences . Septerna will need a new medical chief soon: The drug developer is headed into Phase 2b in chronic spontaneous urticaria in the second half of this year and last month started a Phase 1 in hypoparathyroidism. Its R&D team also has preclinical work in Graves’ disease and a collaboration for oral obesity drugs with Novo Nordisk . → AstronauTx , a London-based “sleep architecture” biotech, has recruited former PepGen and EveryONE Medicines CMO Michelle Mellion to lead its clinical work. The trained neurologist steps into the CMO role as AstronauTx “is preparing to initiate clinical development” for Alzheimer’s disease and other neurological disorders. The startup hasn’t disclosed additional VC funding since its $61 million Series A in 2023. → Muzammil Mustufa has landed at Henderson, NV-based Zura Bio as CBO. Mustufa spent a decade at Amicus Therapeutics , where he was VP of corporate strategy and played a key role in the $4.8 billion sale to BioMarin . Former Tourmaline Bio chief Sandeep Kulkarni is in his first year as CEO of Zura Bio, which is testing its IL-17xBAFF bispecific tibulizumab in hidradenitis suppurativa and systemic sclerosis. → OnCusp Therapeutics hit the scene in January 2024 with a $100 million Series A from Novo Holdings , OrbiMed , F-Prime Capital and a cast of thousands. But there have been minimal updates since then, notably the arrival of former Arcus CMO Dimitry Nuyten to the same position. OnCusp has now added Anthony Kim as CFO after he did some consulting work for Orum Therapeutics , which has made deals with Vertex and Bristol Myers Squibb . He left healthcare investment banking to make his CFO debut at Marker Therapeutics from 2018-22. → Acute ischemic injury specialist Immediate Therapeutics has selected Bradley Newman as global head of manufacturing and supply chain, and Chia-Wen Lee as global head of market access. Newman had multiple roles at Baxter that spanned more than a decade, including senior director, commercial operations for Baxter Biopharma Solutions . Lee is a Moderna and Sanofi Genzyme alum who was head of global market access & value at Viatris . Ex- Harbour BioMed strategy chief and US operations leader Atul Deshpande is running Immediate Therapeutics for a second time after a three-year stint at Peptilogics . → A few band members from Verona Pharma are back together at Achieve Life Sciences . Ex-Verona commercial chief Chris Martin has picked up a seat on the board of directors, while Achieve has also installed Mark Zappia as SVP of commercial and Jim Willis as VP of sales. Zappia and Willis helped Martin with the launch of Verona’s COPD treatment Ohtuvayre as VP of commercial operations and national sales director, respectively. Merck bought Verona last year for $10 billion. → Former Celgene CEO Bob Hugin is chairing the board at Neomorph , the molecular glue partner of choice for Novo Nordisk, Biogen and AbbVie. The San Diego biotech said last month it had raised a $100 million Series B. → Corbus Pharmaceuticals has appointed Century Therapeutics CEO Brent Pfeiffenberger to its board of directors. The 19-year Bristol Myers vet was COO of Neogene Therapeutics before he took over at Century.

Executive ChangeDrug ApprovalPhase 2Phase 3IPO

12 May 2026

·ir.anaptysbio.com

Anaptys Announces First Quarter 2026 Financial Results and Provides Business Update

Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda Announced appointment of Chris Murphy as CFO Announced appointments of Susannah Gray , former CFO of Royalty Pharma, and Owen Hughes , current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO , May 12, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026 , and provided a business update. “Following the completion of the spin-off of First Tracks Bio in late April, Anaptys now exclusively manages the financial collaborations for Jemperli and imsidolimab, with streamlined operations requiring limited FTEs, minimal operating expenses and delivering an EBIT margin greater than 95%,” said Daniel Faga , president and chief executive officer. “With Chris Murphy joining as CFO, who brings deep business development and investment banking experience, our priority continues to be to protect our two royalty streams and return their value to shareholders.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli ( $313 million /£232 million in Q1 2026 sales, with >40% year-over-year growth1) Anaptys continues to expect to achieve > $390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak sales guidance of > $2.7 billion 2 Anaptys estimates Sagard will have accrued ~$275 million in royalties and sales milestones through Q1 2026 and anticipates paydown of the remaining ~$325 million non-recourse debt monetization by the end of Q2 20273 Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer Data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month sBLA review timeline for US FDA approval 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 Data expected 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 Imsidolimab Financial Collaboration FDA target action date (PDUFA) of Dec. 12, 2026 for imsidolimab in generalized pustular psoriasis (GPP) Recent Leadership and Board of Directors Appointments Announced appointment of Chris Murphy as Chief Financial Officer (CFO) Mr. Murphy brings >20 years’ experience in business development, commercial operations, corporate strategy and investment banking in the biopharmaceutical industry Announced appointment of industry veterans Susannah Gray and Owen Hughes to Board of Directors Ms. Gray brings >25 years’ experience in both finance and investment banking in the biopharmaceutical industry, formerly CFO of Royalty Pharma Mr. Hughes brings >25 years’ experience as both an operator and investor in the biopharmaceutical industry, currently leading XOMA Royalty as CEO Stock Repurchase Plan Announced a $100.0 million Stock Repurchase Plan in March 2026 . It will expire on Dec. 31, 2026 , may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock First Quarter Financial Results The separation of Anaptys and First Tracks Bio was completed on April 20, 2026 . As a result, in the first quarter of 2026, the financial results include assets, liabilities and expenses related to both companies. Beginning in the second quarter of 2026, Anaptys expects to reclassify historical First Tracks Bio related assets, liabilities and expenses as discontinued operations. Cash, cash equivalents and investments totaled $286.5 million as of March 31, 2026 , compared to $311.6 million as of Dec. 31, 2025 , for a decrease of $25.1 million due primarily to operating activities offset by $14.0 million received from stock option exercises. Collaboration revenue was $25.6 million for the three months ended March 31, 2026 , compared to $27.8 million for the three months ended March 31, 2025 . The decrease in revenue was primarily due to $9.7 million in revenue recognized for the Vanda license agreement for the three months ended March 31, 2025 offset by Jemperli royalties increasing 44% from $17.2 million to $24.7 million for the three months ended March 31, 2026 . Research and development expenses were $34.0 million for the three ended March 31, 2026 , compared to $41.2 million for the three months ended March 31, 2025 . The decrease for the three months ended March 31, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the phase 1 trials for ANB033. The R&D non-cash, stock-based compensation expense was $4.6 million for the three months ended March 31, 2026 as compared to $4.4 million in the same period in 2025. General and administrative expenses were $26.2 million for the three months ended March 31, 2026 , compared to $14.1 million for the three months ended March 31, 2025 . The increase was due primarily to legal costs for the separation of the company, ongoing GSK litigation and non-cash stock compensation costs incurred for our former Chief Financial Officer and former Chief Legal Officer. The G&A non-cash, stock-based compensation expense was $9.7 million for the three months ended March 31, 2026 as compared to $4.8 million in the same period in 2025. Net loss was $52.9 million for the three months ended March 31, 2026 , or a net loss per share of $1.84 , compared to a net loss of $39.3 million for the three months ended March 31, 2025 , or a net loss per share of $1.28 . About AnaptysBio Anaptys manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning the value of its royalties to shareholders. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.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 whether Anaptys is able to protect its financial collaborations; and its ability to return value to its shareholders. 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 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. This press release also includes a reference to EBIT margin which is a measure not presented in accordance with generally accepted accounting principles in the United States of America (“GAAP”), which Anaptys believes provides important perspective with respect to operational profitability. Non-GAAP financial measures may exclude items that are significant in understanding and assessing Anaptys’ financial results, should not be considered in isolation or as an alternative to GAAP measures, and should be considered only as a supplement to, and not as superior to, GAAP measures. Anaptys cannot predict with certainty the magnitude or scope of certain items that would be included in the most directly comparable GAAP measure to EBIT margin for the relevant future periods, and such items may be significant. Due to these uncertainties, Anaptys cannot provide a quantitative reconciliation of EBIT margin to the most directly comparable GAAP financial measure without unreasonable effort. Investor Contact:Anaptys Investor Relationsinvestors@anaptysbio.com _______________________________________ Source: AnaptysBio, Inc.

Executive ChangeFinancial StatementBreakthrough TherapyPhase 3Phase 1

06 May 2026

·www.prnewswire.com

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76% NEREUS™ (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUS™ BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026 Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026 WASHINGTON, May 6, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026. "Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation." Financial Highlights Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025. Fanapt® net product sales were $29.6 million, up 26% year-over-year. HETLIOZ® net product sales were $15.9 million, down 24% year-over-year. PONVORY® net product sales were $6.2 million, up 10% year-over-year. Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant). Key Commercial Highlights Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026. NEREUS™ is now commercially available nationwide through nereus.us, Vanda's innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUS™ represents a breakthrough in both science and patient access. Key Regulatory & Clinical Development Highlights BYSANTI™ (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027. 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 by the end of 2026. The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) 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. Corporate Highlight On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent. GAAP Financial Results Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025. 2026 Financial Guidance Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™ while maintaining prior ranges for Fanapt® and other products: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 6, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the first 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 8051722. A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 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 8051722. 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 plans for pursuit of FDA approval of imsidolimab for the treatment of GPP, and the related timeline for approval; Vanda's expectations with respect to its continued growth and ability to create value; Vanda's clinical development plans and expected timelines for BYSANTITM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, and VQW-765 in the treatment of adults with social anxiety disorder; 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; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for imsidolimab by December 12, 2026; Vanda's ability to successfully execute the commercial launches of NEREUSTM for the prevention of vomiting induced by motion and BYSANTI™ for the treatments of bipolar I disorder and schizophrenia; 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 clinical study for BYSANTITM for the treatment of MDD and receive results in in the first quarter of 2027; Vanda's ability to complete the Thetis study and receive results in 2026; and Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 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] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

Phase 3Drug ApprovalFinancial StatementExecutive Change

100 Deals associated with Imsidolimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11892	-	-	-

R&D Status

10 top R&D records.

to view more data

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	Vanda Pharmaceuticals, Inc.	07 Jul 2021
Hidradenitis Suppurativa	Phase 2	Poland	AnaptysBio, 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

Clinical Result

Indication

Phase

Evaluation

View All Results

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	wbkodcldmb(nnbvkfnpsh) = wqvomluvob mpmchfmfue (hepjpwapey )	Positive	28 Apr 2026
				Imsidolimab 750 mg	wbkodcldmb(nnbvkfnpsh) = bmmikauovg mpmchfmfue (hepjpwapey )
NCT05366855 (GEMINI-2, CTgov)	Phase 3	Generalized Pustular Psoriasis	42	imsidol (ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC)	vgunzfhpyt = ungagbvtga pxxvlhrddp (nydlojirmm, rjwmulldhz - bupllhlrjg) View more	-	27 Mar 2026
				Placebo (ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC)	vgunzfhpyt = luizwybdjj pxxvlhrddp (nydlojirmm, rtncibgeio - xewftdttjf) View more
NCT05352893 (GEMINI1 \| GEMINI-1, CTgov)	Phase 3	Generalized Pustular Psoriasis	45	Placebo	wzxjunwfce = sfpszciutq pbrhgihzns (gzjanbxmas, kpihxmxqua - olyoghuwix) View more	-	17 Mar 2026
NCT04856930 (CTgov)	Phase 2	Hidradenitis Suppurativa	149	Imsidolimab (Placebo-Controlled Period: Imsidolimab 400/200 mg)	seuqorrcng(ciisezmeqn) = sicrndebqe wsqiykyehj (dfafjjjjvi, 6.05) View more	-	22 Sep 2025
				Imsidolimab (Placebo-Controlled Period: Imsidolimab 200/100 mg)	seuqorrcng(ciisezmeqn) = lnzgqivdsi wsqiykyehj (dfafjjjjvi, 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)	swaihqlits(jnbtgecdnx) = vqgucvbult wbscepeemn (qvcxqqpafc )	Positive	09 May 2024
NCT05352893 (GEMINI1, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab 750mg (GEMINI-1)	rjxbxmhnyo(ulwxejoyov) = sckebaajrg hwgjeuwywg (pgcoywnuah )	Positive	09 May 2024
				Imsidolimab 300mg (GEMINI-1)	rjxbxmhnyo(ulwxejoyov) = wiprfozxyi hwgjeuwywg (pgcoywnuah )
NCT05352893 (GEMINI1, Corporate Publications) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab	rdmvjvvbao(bvebgudppx) = ssdewpvrmk rbcljeitsx (ofywjetrnc ) Met View more	Positive	09 Oct 2023
				Placebo	rdmvjvvbao(bvebgudppx) = tnftlsgfnr rbcljeitsx (ofywjetrnc ) Met
NCT04856917 (CTgov)	Phase 2	Acne Vulgaris	123	Imsidolimab (Imsidolimab 400/200 mg)	xhieovfjii(mkbmafinyh) = sjusgxqqpr wmrjmnrsjk (zrxdeeucgy, 13.63) View more	-	15 Jun 2023
				Imsidolimab (Imsidolimab 200/100 mg)	xhieovfjii(mkbmafinyh) = kegyxnypml wmrjmnrsjk (zrxdeeucgy, 16.38) View more
NCT04697056 (CTgov)	Phase 2	Ichthyosis	5	Imsidolimab (Imsidolimab)	adrlqsdwfq = xxpbroqzpr qlzramupdo (gvxpakgvqe, yrdpsaovzg - frftenjacx) View more	-	02 Mar 2023
				placebo (Placebo)	adrlqsdwfq = jqhukqiueo qlzramupdo (gvxpakgvqe, muajxreidz - vmoxfvppnv) View more
NCT03633396 (POPLAR, CTgov)	Phase 2	Pustulosis of Palms and Soles	59	Placebo (Placebo)	cbwnqvfclo(uoygsydssy) = plkpnpqatf lghejexhhx (blvshkmvxb, 1.48) View more	-	31 May 2022
				Imsidolimab (Imsidolimab)	cbwnqvfclo(uoygsydssy) = ndydcgvgyk lghejexhhx (blvshkmvxb, 1.46) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis