Imsidolimab

WASHINGTON, May 27, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to imsidolimab, a high‑affinity humanized immunoglobulin G4 (IgG4) monoclonal antibody, for the treatment of generalized pustular psoriasis (GPP). Imsidolimab inhibits interleukin‑36 (IL‑36) receptor signaling, addressing the deficiency in the endogenous IL‑36 receptor antagonist regulator that is commonly observed in patients with GPP.1 The MHLW grants orphan drug designation to medicines intended to treat rare diseases with significant unmet medical need. In Japan, approximately 2,200 people have been diagnosed with GPP.2 IL36RN genetic variants—which are associated with dysregulation of the IL‑36 pathway—are enriched in the Japanese population, including well‑characterized founder families in Hokkaido.3 In Japan, orphan drug designation provides development incentives, including subsidies for research and development costs, as well as the potential for up to 10 years of market exclusivity following approval. This designation follows similar regulatory recognition in the United States and underscores the global interest in the potential of imsidolimab to address the significant unmet medical needs of patients with GPP, a rare and severe inflammatory skin disease associated with systemic complications and increased mortality.4 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 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 therapeutic potential of imsidolimab for patients with GPP and the potential to extend regulatory and patent exclusivity for imsidolimab into the late 2030s, are "forward‑looking statements" within the meaning of 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 on 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 regulatory approval of, and to successfully commercialize, imsidolimab for the treatment 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 risks and uncertainties described in the sections titled "Cautionary Note Regarding Forward‑Looking Statements," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in 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 forward‑looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth herein. Vanda cautions investors not to place undue reliance on forward‑looking statements. The information contained in this press release is provided as of the date hereof, and Vanda undertakes no obligation, and expressly disclaims any obligation, to update or revise 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

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.