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Medscape
2 days ago
- Health
- Medscape
S2 Episode 5: Posttransplant Monitoring in Myelofibrosis
This transcript has been edited for clarity. For more episodes, download the Medscape app or subscribe to the podcast on Apple Podcasts, Spotify, or your preferred podcast provider. Tania Jain, MBBS: Hello everyone. We're back in our myelofibrosis for Medscape InDiscussion podcast. This is season two, and this is episode five, where we'll talk about transplant outcomes in myelofibrosis and how to address relapse post-transplant. I'm Tania Jain, and today we have our very special guest, Dr Rachel Salit, who is an associate professor at Fred Hutchinson Cancer Center and the University of Washington School of Medicine. As a hematologist-oncologist, Dr Salit specializes in stem cell transplant, focusing on improving outcomes for patients with myeloproliferative neoplasms. Her research has included developing clinical trials to enhance and improve transplant success, prevent graft-vs-host disease (GVHD), and she also works on initiatives to support patients' return-to-work journeys post-transplant. Welcome, Dr Salit. It's an honor to have you. Rachel Salit, MD: Thank you for having me today. Jain: What we want to talk about today is pre-transplant, post-transplant, and how to think about transplant. I think we would all agree that transplant is presented and thought about differently, to some extent, by different clinicians and others who see patients in the clinic. What is your approach, and how do you go about telling patients about the role of transplant? Salit: The way I approach patients with myelofibrosis is from two different sides. One is the scoring system criteria — going over the Dynamic International Prognostic Scoring System (DIPSS) and the Mutation-Enhanced International Prognostic Scoring System (MIPSS-70). That would include what their blood counts look like, their molecular profile, cytogenetics, whether they have any peripheral blasts, and whether we think they're at imminent danger for transforming to leukemia or needing blood or platelet transfusions. The second side I look at with them is their life goals — what they are hoping for in terms of longevity vs quality of life. I think we've made great strides in transplant in the last 10 years in myelofibrosis since the approval of Janus kinase (JAK) inhibitors. I talk with them about the role of JAK inhibitors in the pretransplant setting — whether they've had one or not — depending on their symptoms and splenomegaly, and how that affects transplant timing. Ultimately, it's their choice. Patients often have strong opinions. There are patients with high-risk disease by scoring systems, but who are having a rather good quality of life and don't want to rush into treatment. Then there are patients with lower risk but who, because of younger age or life goals, want to proceed more expediently. I let the patient guide me. The third component that goes into it is what our donor search looks like. I often don't know that when I first meet the patient, so I always add the caveat: This is the conversation we're having now, but once we assess sibling matches or unrelated donors, risks and benefits might change. Jain: One of the things that challenges me is that there's a lot of prediction involved in the transplant decision, especially the first part you mentioned, about leukemia progression risk. There's no perfect metric to predict someone's transplant outcomes, whether for disease control, preventing relapse, or even nonrelapse mortality. How do you play the prediction game, without a crystal ball? Salit: I think it is one of the most challenging aspects of myelofibrosis. I empathize with patients in that we consider this a somewhat elective procedure that no one wants to need. It's tougher on them than it is for acute myeloid leukemia (AML) patients, where we say, 'This is your option, and you need to do it now.' For me, I try to look at the disease kinetics. When did it develop? How long has it been stable? If they have peripheral blasts in their blood, have they stayed at 1% for 2 years, or have they risen to 2% or 3%? Have their counts stayed stable? Is their spleen growing? Are their symptoms increasing? If patients have poor-risk factors but stable disease, I'm less aggressive than I am with patients who have more benign features but rapidly progressing disease. Sometimes in younger patients, the disease progresses faster than expected, especially if they have just one high-risk mutation. Jain: I always say that one of the most important things to follow is the trajectory of disease. When counts begin to drop or blasts start to appear, that makes you pause and think about transplant, or at least do a bone marrow biopsy to help make that decision. I want to shift gears. I know you've been involved in defining remission post-transplant, which is a huge unmet need. Many disease features don't resolve quickly after transplant, yet we consider the transplant successful. The forms and shapes that remission or recurrence can take post-transplant have evolved. Can you share how you got involved in unifying the concept of remission post-transplant and what insights you can offer for our audience? Salit: I got involved in this from two angles. Clinically, it's long been unsatisfying to tell patients post-transplant that they have low counts, persistent fibrosis, or splenomegaly when we discharge them from the acute transplant service at day 100. The providers we discharge them to — often general oncologists — aren't always sure what to say. Are you in remission? How long will it last? How do we test for it? The second part came from my work on the Medicare–Center for International Blood and Marrow Transplant Research (CIBMTR)) composite study, looking at whether transplant benefits patients over 55. We've been working on this for the past 7 years. When we met to define the response to transplant, we used the newly developed International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria for drug response in myelofibrosis, and we found that to be very complex for CIBMTR reporting. The people reviewing charts were not reporting consistently. I was approached by Wael Saber from CIBMTR to help develop a consistent remission definition so that centers reporting outcomes — remission, persistent disease, or relapse — could be compared. We want to draw conclusions about what regimens and donors are working best. We recognized that, unlike AML patients who go into transplant in CR1 (first complete remission), myelofibrosis patients go into transplant with active disease: persistent blasts, fibrosis, splenomegaly. We formed a committee of myelofibrosis transplant experts from the US and Europe. We wanted both CIBMTR and the European Society for Blood and Marrow Transplantation (EBMT) to have the same criteria so we could collaborate and combine data. The strongest takeaway was that the main thing transplant can do that drugs currently cannot is put patients into molecular remission. Most patients have driver mutations — JAK2, CALR, MPL — and we know the majority clear these mutations post-transplant. We recognized that patients with molecular remission may still have low counts or morphologic abnormalities. We classified these as subsets of molecular remission. We also agreed that persistent molecular abnormalities — especially if decreasing — shouldn't be considered relapse. Persistent disease can clear over time with rising CD3 chimerism and immune suppression taper. We reserved 'relapse' for patients who had previously cleared their mutation and then redeveloped it. That's a much more concerning scenario requiring intervention. Jain: That makes a lot of sense. One way I explain it to patients is that a transplant is an intervention with curative potential, but disease elimination takes time, even after donor hematopoiesis is established. It's not an immediate clinical remission — spleen and counts take time to improve. But once donor hematopoiesis is present, that can eventually trigger graft-vs-leukemia activity to eliminate residual disease. Do you know if there's a difference in how CIBMTR and EBMT capture relapse? Salit: I honestly don't know. But one of the goals of our project, with about six stakeholders from each registry, was to create a uniform definition. I think the recent New England Journal of Medicine paper by Gagelmann and colleagues spearheaded this molecular remission definition. CIBMTR and Dr Saber are very enthusiastic about this, and I think we can develop reporting forms that consistently capture remission, persistent disease, and relapse as three categories. We acknowledge there will be missing data. Not every center regularly tests molecular driver mutations. We've also discussed the role of chimerism. Fractionated chimerism is important, but most European centers don't assess it. They can do weekly molecular tests; we might test every 3 months at best. So, blood counts and chimerism will still play a role. I've piloted this approach with my patients, and they find it more satisfying. At day 100, I can say, 'You still have fibrosis, splenomegaly, and low platelets — but your JAK2 is negative. We're considering this remission.' That's much more reassuring for them than wondering why we even did the transplant. Jain: I totally agree. Bringing together the American and European efforts — making them globally unified — would be a huge advancement in research. Right now, it's hard to use or compare registry data across systems since it's not apples to apples. You mentioned you're already using this with your patients. There are times when spleen, fibrosis, or counts aren't fully normalized. Can you share your approach for relapse or 'impending relapse' when you see persistent disease features like cytopenias, transfusion needs, splenomegaly, dropping chimerism, or persistent molecular mutations? Salit: We check molecular driver mutations every 3 months — at months 3, 6, 9, and 12. If the 3-month result is negative but the patient still has low CD3 chimerism, needs transfusions, or has fibrosis, we start tapering immune suppression at day 100. We follow chimerism monthly during tapering. If it's not at 100% by 6 months, we may do a bone marrow biopsy to see if anything concerning is present. If the mutation's variable allele frequency is decreasing, that's reassuring. If it's back and chimerism is dropping — say it was 100% at day 100 and 90% at 6 months — we consider donor lymphocyte infusion (DLI), assuming they're off immune suppression and don't have GVHD. If they're still on immune suppression, we taper conservatively and wait a month before giving DLI. We only use therapy like hypomethylating agents and JAK inhibitors if blasts return in the peripheral blood or marrow, or if abnormal cytogenetics reappear. Jain: Those are tough situations — when blasts are visible, or disease features reappear. How often do you consider a second transplant in myelofibrosis? Salit: Not often. Thankfully, we're seeing only 5%-10% relapse rates. At our center, we're still doing relatively mild ablative transplants: Cytoxan/busulfan for those under 60, or decitabine/melphalan for those over 60. If a patient completely loses CD34 or CD33 chimerism, we consider a second transplant. There's concern that giving DLI in that setting could cause aplasia. If the disease burden is too high, we go straight to the second transplant. Jain: That makes sense. Well, this was phenomenal. Thinking about transplant is a nuanced process, and we loved hearing your thoughts. We look forward to reading about the remission definitions post-transplant and implementing them in the clinic. On behalf of our audience, thank you so much for your time. That concludes episode 5 on transplant outcomes in myelofibrosis. We'll see you in the next episode. Listen to additional seasons of this podcast. Primary Myelofibrosis Role of Hematopoietic Stem Cell Transplantation in Patients With Myeloproliferative Disease Decreasing Chronic Graft-Versus-Host Disease Rates in All Populations Diagnosis and Evaluation of Prognosis of Myelofibrosis: A British Society for Haematology Guideline Prognostic Value of Blasts in Peripheral Blood in Myelofibrosis in the Ruxolitinib Era Acute Myeloid Leukemia (AML) CIBMTR Myelofibrosis Medicare Study Proposals for Revised International Working Group-European LeukemiaNet Criteria for Anemia Response in Myelofibrosis Utility of Assessing CD3+ Cell Chimerism Within the First Months After Allogeneic Hematopoietic Stem-Cell Transplantation for Acute Myeloid Leukemia Clearance of Driver Mutations After Transplantation for Myelofibrosis Donor Lymphocyte Infusion and Molecular Monitoring for Relapsed Myelofibrosis After Hematopoietic Cell Transplantation Medscape © 2025 WebMD, LLC Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape. Cite this: Posttransplant Monitoring in Myelofibrosis - Medscape - Jun 10, 2025.
Yahoo
19-05-2025
- Business
- Yahoo
Graft Versus Host Disease (GVHD) Global Clinical Trials Review 2025: Unlocking Strategies from GVHD Clinical Trials Across G7 & E7 Regions
Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Graft Versus Host Disease (GVHD) - Global Clinical Trials Review, 2025" has been added to offering. The report offers a comprehensive analysis of the GVHD clinical trial landscape worldwide. Presenting top-line data, this report furnishes details about the number of trials and their average enrollment across major countries. It covers trials by region, country (G7 & E7), phase, status, endpoints, and sponsor types. This report also highlights key drugs involved in ongoing trials, curated from the Pharma Clinical Trials Database. This database consolidates information from over 80 global trial registries, conferences, journals, and news sources and is periodically updated through a dynamic process to ensure data accuracy and relevance. The insights provided in this report enhance strategic decision-making and help formulate effective strategies to gain a competitive edge. Scope Provides a snapshot of the global clinical trials landscape, offering top-level data by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type, and End Point Status. Reviews leading companies in the sector and lists all relevant trials with titles, phases, and statuses. Details unaccomplished trials, including terminated, suspended, and withdrawn, along with reasons for uncompletion. Shows enrollment trends over the past five years and shares the latest news from the past three months. Specific sections might be modified based on data availability and relevance to the disease. Reasons to Buy Supports strategic business investment decisions. Identifies optimal locations for cost-effective and timely clinical trials. Provides a top-level analysis of the Global Clinical Trials Market, pinpointing key business opportunities. Clarifies trial count and enrollment trends globally, aiding market understanding. Compares completed with incomplete trials to assist in interpreting clinical trial success rates. Offers an assessment of trials at global, regional, and country levels. Sections may be customized based on data relevancy to the implicated disease. Key Topics Covered: Report Guidance Clinical Trials by Region Clinical Trials and Average Enrollment by Country Top Five Countries Contributing to Clinical Trials in Asia-Pacific Top Five Countries Contributing to Clinical Trials in Europe Top Countries Contributing to Clinical Trials in North America Top Five Countries Contributing to Clinical Trials in Middle East and Africa Top Five Countries Contributing to Clinical Trials in Central and South America Clinical Trials by G7 Countries Clinical Trials by Phase Clinical Trials by Trial Status Clinical Trials by End Point Status Subjects Recruited Over a Period of Time Clinical Trials by Sponsor Type Prominent Sponsors Top Companies Participating in Graft Versus Host Disease (GVHD) Therapeutics Clinical Trials Prominent Drugs Latest Clinical Trials News on Graft Versus Host Disease (GVHD) Clinical Trial Profile Snapshots Appendix A selection of companies mentioned in this report includes, but is not limited to: Sanofi Incyte Corp Novartis AG Johnson & Johnson Pfizer Inc Takeda Pharmaceutical Co Ltd Mallinckrodt Plc Roche Holding AG Bristol-Myers Squibb Co Bellicum Pharmaceuticals Inc For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Business Wire
29-04-2025
- Business
- Business Wire
Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today reports 2025 first quarter financial results, and provides a status update on the Company's clinical development portfolio. "The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We also continued to advance our innovative pipeline, which will be critical for driving long-term growth. The positive Phase 3 results for povorcitinib in hidradenitis suppurativa in addition to the proof-of-concept in chronic spontaneous urticaria, strengthens the potential of povorcitinib as a multibillion-dollar product addressing patient needs across the five indications currently in development.' Key Commercial Highlights Jakafi ® (ruxolitinib): Net product revenues for the first quarter 2025 of $709 million (+24% Y/Y): Net product revenue growth in the first quarter of 2025 versus the same quarter in the prior year, was driven by an increase in paid demand, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025. Opzelura ® (ruxolitinib) cream: Net product revenues for the first quarter 2025 of $119 million (+38% Y/Y): U.S. net product revenue of $95 million in the first quarter of 2025 increased 20% compared to the first quarter of 2024 driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo, partially offset by a reduction in channel inventory. Opzelura inventory levels were within normal range at the end of the first quarter of 2025. Ex-U.S. net product revenues of $23 million in the first quarter of 2025 were primarily driven by continued growth in sales in Germany and France, as well as the recent launches in Italy and Spain. Pipeline Updates Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are enrolling patients. Initial proof of concept data for both studies are anticipated in 2025. A Phase 2 trial evaluating axatilimab (Niktimvo ™) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients. A Phase 3 trial evaluating axatilimab in combination with corticosteroids in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients. Other Hematology/Oncology – key highlights Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments. The Phase 3 study evaluating tafasitamab as first-line treatment for DLBCL is ongoing. The Phase 3 data are anticipated in the second half of 2025. The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in the second half of 2025. Inflammation and Autoimmunity (IAI) – key highlights Ruxolitinib Cream In March 2025, results from two Phase 3 studies (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in patients with prurigo nodularis (PN) were presented in a late-breaking oral session at the American Academy of Dermatology annual meeting. The TRuE-PN1 study met the primary endpoint of a > 4-point improvement from baseline in Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 and all key secondary endpoints. The TRuE-PN2 study did not reach statistical significance for the primary endpoint, resulting in the key secondary endpoints with nominal p-values. These key secondary endpoints still demonstrate positive trends for ruxolitinib cream 1.5% versus vehicle. These data will inform planned discussions with regulatory authorities on submission. A Phase 3 trial for ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA. Povorcitinib (INCB54707) In April 2025, Incyte announced positive topline results from the Phase 2 study evaluating povorcitinib in patients with chronic spontaneous urticaria (CSU). The study met the primary endpoint at Week 12 of change from baseline in the Urticaria Activity Score summed over 7 days (UAS7). Povorcitinib was well tolerated with no new safety signals observed. These data will support planned discussions with regulatory agencies and will be presented at an upcoming medical conference. In March 2025, positive results from the Phase 3 studies (STOP-HS1 and STOP-HS2) of povorcitinib in patients with HS were presented and demonstrated that both studies met their primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 and at both tested doses (45mg and 75mg). In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30. Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction. Additional longer-term data demonstrate that at Week 18, HiSCR rates continue to improve over Week 12 in patients treated with povorcitinib including high levels of response in those patients previously treated on placebo and crossed over to active povorcitinib treatment. These data support the planned regulatory submission of povorcitinib for the treatment of HS worldwide. Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with PN versus placebo are ongoing and enrolling patients. A Phase 2 trial evaluating povorcitinib in asthma is ongoing and enrolling. Data are anticipated in the second half of 2025. Other - key highlights In February 2025, Incyte and Genesis Therapeutics, Inc. (Genesis) entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte. Incyte receives exclusive rights to develop and commercialize collaboration products leveraged through Genesis' GEMS artificial intelligence (AI) platform. 2025 First Quarter Financial Results The financial measures presented in this press release for the three months ended March 31, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ('GAAP'), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte's GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company's business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company's core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company's core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte's operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors' ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended March 31, % Change (as reported) % Change (constant currency) 1 2025 2024 Net product revenues: Jakafi $ 709,412 $ 571,839 24 % NA Opzelura 118,705 85,724 38 % 39 % Iclusig 29,544 30,343 (3 %) — % Pemazyre 18,440 17,676 4 % 6 % Minjuvi/ Monjuvi 29,551 23,874 24 % 25 % Niktimvo 13,613 — NM NA Zynyz 3,009 467 544 % NA Total net product revenues 922,274 729,923 26 % 27 % Royalty revenues: Jakavi 92,145 89,595 3 % 6 % Olumiant 30,800 30,589 1 % 6 % Tabrecta 6,413 5,234 23 % NA Other 1,266 548 131 % NM Total royalty revenues 130,624 125,966 4 % Total net product and royalty revenues 1,052,898 855,889 23 % Milestone and contract revenues — 25,000 — % — % Total GAAP revenues $ 1,052,898 $ 880,889 20 % NM = not meaningful NA = not applicable 1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results. Expand Product and Royalty Revenues Total net product and royalty revenues for the quarter ended March 31, 2025 increased 23% over the prior year comparative period. Total net product revenues for the quarter ended March 31, 2025 increased 26% over the prior year comparative period primarily driven by the following: Jakafi net product revenue increased 24% versus the prior year comparable period, driven by an increase in paid demand of 10% reflecting continued demand growth in all indications, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and 7% favorable impact from less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025. Opzelura net product revenue increased 38% due to continued growth in new patient starts and refills in the U.S. with U.S. paid demand up 24% versus the first quarter of 2024, partially offset by a reduction in channel inventory, and increased contribution from ex-U.S. driven by continued uptake in Germany and France, as well as growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the first quarter of 2025. Minjuvi/Monjuvi net product revenue increased 24% as a result of the first quarter of 2025 reflecting three months of net product revenues in the U.S., compared to two months of net product revenue in the first quarter of 2024 due to the acquisition of U.S. rights to Monjuvi, which closed in February 2024. Niktimvo net product revenue driven by the commercial launch of the product during the first quarter of 2025. Operating Expenses Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended March 31, 2025 increased 20% and 22% respectively, compared to the same period in 2024 primarily due to increased royalty expense. Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2025 increased 2% and 3%, respectively, compared to the same period in 2024, reflecting continued investment in our late stage development assets and timing of certain expenses. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2025 increased 8% and 9%, respectively, compared to the same period in 2024 primarily due to timing of consumer marketing activities and of certain other expenses. Other Financial Information Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended March 31, 2025, compared to the same period in 2024, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig. Operating income GAAP and Non-GAAP operating income for the three months ended March 31, 2025 increased 123% and 76%, respectively, compared to the same period in 2024, driven primarily by growth in net product revenue. Cash, cash equivalents and marketable securities position As of March 31, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.4 billion and $2.2 billion, respectively. 2025 Financial Guidance Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its full year 2025 Jakafi revenue guidance. Guidance for Opzelura includes net product revenue for pediatric atopic dermatitis which has an anticipated approval in the second half of 2025. Guidance for other oncology net product revenues include net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma. Approvals for these indications are anticipated in the second half of 2025. Guidance for research and development excludes the $15 million of expense for the full year 2025 related to our recently announced collaboration with Genesis. Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13753168. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13753168. The conference call will also be webcast live and can be accessed at About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. About Jakafi ® (ruxolitinib) Jakafi ® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Opzelura ® (ruxolitinib) Cream Opzelura ® (ruxolitinib) cream, a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. Following accelerated approval by the U.S. Food and Drug Administration in July 2020, Monjuvi ® (tafasitamab-cxix) is being commercialized in the United States by Incyte. In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in August 2021. XmAb ® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are (registered) trademarks of Incyte. About Pemazyre ® (pemigatinib) Pemazyre ® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre is a trademark of Incyte. About Iclusig ® (ponatinib) tablets Iclusig ® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Zynyz ® (retifanlimab-dlwr) Zynyz ® (retifanlimab) is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a trademark of Incyte. About Niktimvo™ (axatilimab-csfr) Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte's potential for continued performance and growth; Incyte's ability to achieve both its full-year and long-term objectives; Incyte's financial guidance for 2025, including its expectations regarding sales of and demand for Jakafi and Opzelura; expected revenue contribution from Niktimvo and additional near-term launches; the potential of povorcitinib to be a multibillion-dollar product; the possibility for 2025 to be a transformational year for Incyte in terms of launches, phase 3 study initiations, pivotal readouts and proof of concept readouts; Incyte's potential to have more than 10 high impact launches by 2030; the potential and progress of programs in our pipeline; ongoing clinical trials and clinical trials that may be initiated; expectations regarding discussions with regulators, regulatory submissions and regulatory approvals; plans to present data at upcoming medical conferences; Incyte's exposure to potential tariffs; and 2025 newsflow items. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA, EMA and other regulatory agencies; Incyte's dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte's products and the products of Incyte's collaboration partners; the acceptance of Incyte's products and the products of Incyte's collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte's products and the products of Incyte's collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte's products and the products of Incyte's collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte's and its collaboration partners' ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) March 31, 2025 December 31, 2024 ASSETS Cash, cash equivalents and marketable securities $ 2,408,658 $ 2,158,092 Accounts receivable 823,134 853,154 Property and equipment, net 765,359 763,411 Finance lease right-of-use assets, net 29,892 30,803 Inventory 429,286 407,199 Prepaid expenses and other assets 243,470 181,382 Equity investments 17,463 18,814 Other intangible assets, net 107,611 113,803 Goodwill 155,593 155,593 Deferred income tax asset 768,899 762,071 Total assets $ 5,749,365 $ 5,444,322 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable, accrued expenses and other liabilities $ 1,849,681 $ 1,765,733 Finance lease liabilities 37,121 37,961 Acquisition-related contingent consideration 195,000 193,000 Stockholders' equity 3,667,563 3,447,628 Total liabilities and stockholders' equity $ 5,749,365 $ 5,444,322 Expand INCYTE CORPORATION (unaudited, in thousands, except per share amounts) Three Months Ended March 31, 2025 2024 GAAP Net Income $ 158,203 $ 169,548 Adjustments 1: Non-cash stock compensation from equity awards (R&D) 2 36,724 36,792 Non-cash stock compensation from equity awards (SG&A) 2 23,399 22,373 Non-cash stock compensation from equity awards (COGS) 2 859 613 Non-cash interest 3 82 108 Loss (gain) on equity investments 4 1,343 (99,947 ) Amortization of acquired product rights 5 5,384 5,384 Loss (gain) on change in fair value of contingent consideration 6 11,572 (456 ) MorphoSys transition costs 7 — 4,579 Escient acquisition related compensation expense 8 535 — Tax effect of Non-GAAP pre-tax adjustments 9 (8,642 ) (6,275 ) Non-GAAP Net Income $ 229,459 $ 132,719 Non-GAAP net income per share: Basic $ 1.18 $ 0.59 Diluted $ 1.16 $ 0.58 Shares used in computing Non-GAAP net income per share: Diluted 198,197 227,219 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2025 are milestones of $0 earned from our collaborative partners, as compared to $25,000 of milestones earned for the three months ended March 31, 2024. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2025 and 2024 are upfront consideration and milestones of $15,500 and $1,000, respectively, related to our collaborative partners. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the (Loss) gain on equity investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the Loss (gain) on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $4,031 for the three months ended March 31, 2024, and $548 is included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three months ended March 31, 2024. MorphoSys transition costs primarily represent employee related costs to transition research and development and selling, general and administrative activities to us under the former collaboration agreement with MorphoSys. 8 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $535 for the three months ended March 31, 2025. Escient acquisition related compensation expense represents non-recurring charges associated with severance payments to former Escient employees. 9 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. The Non-GAAP net income for the three months ended March 31, 2024 should have been $132,719 compared to the $145,269 previously disclosed to correct a transposition error in the tax effect of Non-GAAP pre-tax adjustments. For the three months ended March 31, 2024, the tax effect of Non-GAAP pre-tax adjustments should have been ($6,275) instead of $6,275. This correction is reflected in the table above. Expand
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28-02-2025
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Incyte to Unveil New Data from its Dermatology Portfolio at 2025 American Academy of Dermatology (AAD) Annual Meeting
- Featured abstracts for ruxolitinib cream (Opzelura®) include multiple presentations in atopic dermatitis and late-breaking data in prurigo nodularis (PN) - Pipeline data presented includes data for axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD) WILMINGTON, Del., February 28, 2025--(BUSINESS WIRE)--Incyte (Nasdaq: INCY) today announced that multiple abstracts featuring new data from its dermatology portfolio will be presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, being held March 7–11, 2025, in Orlando. "We look forward to sharing new data for ruxolitinib cream (Opzelura®) across multiple indications, including prurigo nodularis, and axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD) at this year's AAD Annual Meeting," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. "Incyte's active participation in this key congress reinforces our commitment to addressing critical needs in dermatology while fostering meaningful dialogue with researchers, patients and advocates to inform the development of innovative treatments." Key abstracts include: Late-Breaking Oral Presentation Prurigo Nodularis (PN) Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Results From a Phase 3, Randomized, Vehicle-Controlled Study (TRuE-PN1)(Session: S028 – Late-Breaking Research: Session 1. Saturday, March 8, 2025, 9:24 a.m. ET) ePoster Exhibits Atopic Dermatitis (AD) Long-Term Safety of Ruxolitinib Cream in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Adverse Events of Interest from the TRuE-AD1 and TRuE-AD2 Phase 3 Studies (Abstract: #64524) Association of Ruxolitinib Cream Initiation with Reduction in Use of Other Topical Treatments, Oral Corticosteroids, and Biologics for Atopic Dermatitis, Regardless of Previous Use of Biologics (Abstract: #64526) 52-Week Disease Control and Safety with As-Needed Application of Ruxolitinib Cream in Children Aged 2 to 11 Years with Moderate and/or More Extensive Atopic Dermatitis: Subgroup Analysis from the TRuE-AD3 Study (Abstract: #64656) Ruxolitinib Cream Demonstrated Long-Term Disease Control and Quality of Life Benefits in Adults and Adolescents with Mild to Moderate Atopic Dermatitis (Abstract: #64727) Graft-Versus-Host Disease (GVHD) Axatilimab for Patients with Dermatologic Manifestations of Chronic Graft-Versus-Host Disease: A Post Hoc Analysis (Abstract: #64616) More information regarding the 2025 AAD Annual Meeting can be found at: About Opzelura® (ruxolitinib) Cream 1.5%Opzelura, a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Niktimvo™ (axatilimab-csfr)Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. About Povorcitinib (INCB54707)Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 3 clinical trials for vitiligo, hidradenitis suppurativa (HS) and prurigo nodularis (PN), as well as Phase 2 trials for asthma and chronic spontaneous urticaria (CSU). About IncyteA global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking StatementsExcept for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte's clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte's goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements. View source version on Contacts Media media@ Investors ir@
