Genmab zahájí klinickou studii fáze 1/2 kombinace INCB161734, petosemtamabu a standardní chemoterapie v první linii léčby metastatického kolorektálního karcinomu s mutací KRAS G12D.
Incyte (Nasdaq:INCY) and Genmab A/S (Nasdaq:GMAB) today announced a clinical trial collaboration to evaluate INCB161734, Incyte’s investigational, potent and selective KRAS G12D inhibitor, in combination with petosemtamab, Genmab’s investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring KRAS G12D mutation, an area with substantial unmet medical need.
“Metastatic colorectal cancer remains difficult-to-treat, underscoring the importance of evaluating novel combinations grounded in complementary scientific approaches with the potential to enhance efficacy,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Our collaboration with Genmab will explore the potential of combining KRAS G12D inhibition with LGR5-targeted EGFR inhibition and standard-of-care chemotherapy, with the goal of advancing a new first-line treatment approach for patients with metastatic colorectal cancer.”
“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding potential treatment options for more patients.”
Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating INCB161734 in combination with petosemtamab and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.
KRAS mutations occur in approximately 40% of colorectal cancers, with G12D being the most common KRAS mutation. These cancers are associated with poor prognosis, underscoring the need for new treatment approaches. The collaboration reflects a shared focus on investigating whether agents with distinct and potentially complementary mechanisms, combined with standard-of-care chemotherapy, may offer a path toward a new treatment option for patients with KRAS G12D-mutated metastatic colorectal cancer.
About INCB161734
INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.
INCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073) study which is currently enrolling patients with previously untreated KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy.
INCB161734 is also being evaluated as a monotherapy and in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160).
About Petosemtamab (GEN1158)
Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Petosemtamab is being evaluated in combination with chemotherapy in two Phase 3 trials in first- and second-line RAS/BRAF wild-type metastatic CRC. Please visit https://clinicaltrials.gov/ for more information.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody-drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s clinical trial collaboration with Genmab; the design, initiation, timing, conduct, sponsorship and funding of the planned studies; the potential presented by INCB161734, petosemtamab and the combination of these investigational therapies with standard-of-care chemotherapy; the potential for the combination to provide a new treatment option for patients with first-line KRAS G12D-mutated metastatic colorectal cancer; expectations regarding the initiation, timing, progress and results of ongoing and planned clinical trials for INCB161734; whether or when INCB161734, petosemtamab or any combination regimen will be approved or commercially available for use in humans anywhere in the world; Incyte’s oncology portfolio and development strategy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including whether preclinical or early clinical results will be replicated in later-stage or larger clinical trials; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects in accordance with planned schedules; changes in clinical development plans; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory approval; the efficacy or safety of Incyte’s products and product candidates; Incyte’s ability to successfully develop and commercialize its product candidates; Incyte’s reliance on third parties and collaboration partners, including with respect to the planned studies described herein; the availability and effectiveness of competing treatments; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; greater than expected expenses, including expenses relating to clinical development, litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Genmab Forward-Looking Statements
This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filingswith the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect®, and KYSO®.
View source version on businesswire.com: https://www.businesswire.com/news/home/20261024426058/en/
Společnost Incyte by měla za čtvrtletí končící v září 2026 vykázat ztrátu 3,50 USD na akcii při tržbách ve výši 1,48 miliardy USD, což představuje meziroční nárůst o 8,5 %.
The market expects Incyte (INCY - Free Report) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.
The earnings report, which is expected to be released on October 29, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.
Zacks Consensus EstimateThis specialty drugmaker is expected to post quarterly loss of $3.50 per share in its upcoming report, which represents a year-over-year change of -254.9%.
Revenues are expected to be $1.48 billion, up 8.5% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.28% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Incyte?For Incyte, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -11.02%.
On the other hand, the stock currently carries a Zacks Rank of #5.
So, this combination makes it difficult to conclusively predict that Incyte will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Incyte would post earnings of $2 per share when it actually produced earnings of $3.09, delivering a surprise of +54.50%.
Over the last four quarters, the company has beaten consensus EPS estimates three times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Incyte doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Knight Therapeutics získala v Brazílii urychlené regulační schválení v režimu pro vzácná onemocnění přípravku NIKTIMVO pro pacienty ve věku od 6 let s hmotností nejméně 40 kg s chronickou reakcí štěpu proti hostiteli po selhání nejméně dvou systémových terapií.
MONTREAL, Oct. 06, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today it has received expedited regulatory approval under ANVISA’s rare disease pathway for NIKTIMVO® (axatilimab), for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 6 years and older weighing at least 40 kg.1
“For patients living with chronic graft-versus-host disease who have exhausted two prior lines of therapy, access to a new treatment option can be life-changing. NIKTIMVO® offers a first-in-class mechanism that targets the underlying drivers of this debilitating condition, and we are proud to bring it to patients in Brazil. This approval reflects the strength of our partnership with Incyte and our shared commitment to ensuring that patients in Brazil have access to innovative therapies that can make a meaningful difference in their lives,” said Samira Sakhia, President and CEO of Knight Therapeutics.
In September 2021, Knight and Incyte (NASDAQ: INCY) had entered into an exclusive supply and distribution agreement for MINJUVI® (tafasitamab) and PEMAZYRE® (pemigatinib) in Latin America. In August 2025, Knight expanded its existing relationship with Incyte, to add exclusive rights to distribute ZYNYZ® (retifanlimab) and NIKTIMVO® (axatilimab) in Latin America. Under the terms of the amended agreement, Incyte is responsible for the development, manufacture and supply of such products to Knight, and Knight is responsible for seeking the necessary regulatory approvals and commercializing such products in Latin America.
About NIKTIMVO®
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 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).2
In September 2021, Syndax Pharmaceuticals, Inc. 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®, MINJUVI®, PEMAZYRE® and ZYNYZ® are trademarks of Incyte. All other trademarks are the property of their respective owners.
About cGVHD
Chronic GVHD is a serious complication of allogeneic stem cell transplantation in which the donor’s immune cells attack the recipient’s tissues, often occurring during the first-year post-transplant.3 Chronic GVHD involves features of autoimmunity and immunodeficiency, multiple organs (such as the skin, liver, lungs, and gastrointestinal tract), irreversible fibrotic manifestations, and systemic toxicities complicated by the use of immunosuppressants which all contribute to devastating health consequences such as mortality, morbidity, and decreased quality of life in patients.4 There are approximately 1400 – 1800 reported allogeneic transplants in Brazil every year.5 Chronic GVHD is the most common late complication after allogeneic hematopoietic cell transplantation affecting 30%-70% of recipients, globally.4 Based on a recent analysis by the Brazilian National hematopoietic stem cell transplantation (HSCT) Registry, in collaboration with Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO), Center for International Blood and Marrow Transplant Research (CIBMTR), and Hematopoietic Cell Transplantation Brazilian Registry (HCTBR), the 2-year cumulative incidence cGVHD was determined to be 29.5%.6
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on the TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's website at www.knighttx.com or www.sedarplus.ca.
Forward-Looking Statements for Knight
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.’s Annual Report and in Knight Therapeutics Inc.’s Annual Information Form for the year ended December 31, 2025, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
References
ANVISA, Prescribing Information. Approved on October 5, 2026.Incyte Corporation. NIKTIMVO (axatilimab-csfr) injection, for intravenous use: Highlights of prescribing information / full prescribing information. Revised August 2024. Accessed June 10, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761411s000lbl.pdfJagasia M, Giglia J, Chinratanalab W, et al. Incidence and outcome of chronic graft-versus-host disease using National Institutes of Health consensus criteria. Biol Blood Marrow Transplant. 2007;13(10):1207-1215. doi:10.1016/j.bbmt.2007.07.001Kitko CL, Arora M, DeFilipp Z, et al. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study. J Clin Oncol. 2023;41(10):1864-1875. doi:10.1200/JCO.22.00958Associação Brasileira de Transplante de Órgãos. (2024). Registro Brasileiro de Transplantes (RBT): Dados numéricos da doação de órgãos e transplantes realizados por estado e instituição no período: janeiro/setembro 2024 (Ano XXV, nº 3) [Report]. Retrieved May 26, 2026, from https://site.abto.org.br/wp-content/uploads/2024/11/RBT2024-3t-abto-populacao.pdfSimione, Anderson Joao, et al. “Hematopoietic Cell Transplantation in Brazil: A National Benchmarking Study Focused on the Foundation for the Accreditation of Cellular Therapy (FACT) Performance Indicators.” Journal of Bone Marrow Transplantation and Cellular Therapy (JBMTCT), vol. 6, no. 1, 2025, pp. 1–13. doi: 10.46765/2675-374X.2025V6N1P270. CONTACT INFORMATION FOR KNIGHT:
Společnost Mirum Pharmaceuticals získala od FDA schválení pro Atebrioz pro léčbu FOP u pacientů od 12 let. Ve studii PROGRESS snížil po 24 týdnech objem nové HO o 3,2 cm³.
Key Takeaways MIRM's Atebrioz gets FDA approval to reduce new HO volume in FOP patients aged 12 and older.PROGRESS data showed a 3.2-cubic-centimeter reduction in new HO volume after 24 weeks.Atebrioz's pediatric program is advancing, with enrollment completed in one cohort and underway in another. Mirum Pharmaceuticals (MIRM - Free Report) announced that its oral pill zilurgisertib secured FDA approval for the treatment of fibrodysplasia ossificans progressiva (FOP) in patients aged 12 years and older. The drug will be marketed under the name Atebrioz.
Mirum Pharmaceuticals expects the drug to become commercially available in the United States in October through Mirum Access Plus, a patient support program designed to help navigate treatment access. It is currently under regulatory review for FOP indication in the European Union.
FOP is an ultra-rare genetic disease affecting about 300 people in the United States and 900 worldwide. It causes abnormal bone formation in soft tissues, which progressively restricts movement, mobility and daily activities.
Atebrioz is an oral activin receptor-like kinase 2 inhibitor and is recommended at a dose of 100 mg once daily for FOP. The drug is designed to reduce the volume of total new heterotopic ossification (HO). HO indicates the abnormal formation of extra bone tissue in muscles and other soft tissues where bone normally should not grow.
Mirum Pharmaceuticals obtained exclusive worldwide rights to Atebrioz from Incyte (INCY - Free Report) in April 2026 for the drug’s development and commercialization. Under the agreement, Incyte received an upfront payment and remains eligible to receive additional development, regulatory and sales-based milestone payments, along with tiered royalties on worldwide net sales.
Year to date, MIRM shares have rallied 13.5% compared with the industry’s 8.3% growth.
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MIRM’s Atebrioz Approval for FOP Validates PROGRESS DataThe FDA approval for Atebrioz was supported by data from cohort 1 of the phase II PROGRESS study conducted by Incyte, which evaluated Atebrioz in adults and children aged 12 years and older with FOP. The study assessed the total new HO volume, including growth of existing bone lesions and development of new lesions.
After 24 weeks, patients treated with the drug achieved an average 3.2 cubic-centimeter reduction in total new HO lesion volume compared with a 24.6 cubic-centimeter increase in patients receiving placebo. The treatment benefit was sustained through week 48.
Atebrioz was generally well-tolerated, and the most common side effects were headache, joint pain, upper respiratory tract infection, nosebleeds and nausea.
The approval allows Mirum Pharmaceuticals to build a presence in the FOP market while it advances Atebrioz into younger pediatric patients. In this regard, the company is advancing cohorts 2 and 3 of the PROGRESS study. Enrollment has been completed in cohort 2 of children aged six to less than 12 years and cohort 3 is actively enrolling children aged two to less than 12 years with FOP.
MIRM’s Zacks Rank & Stock to ConsiderMirum Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) and AC Immune (ACIU - Free Report) carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 85.4% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 19.8% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Specialised Therapeutics rozšiřuje partnerství s Incyte o komercializaci, distribuci a registraci krému ruxolitinib (Opzelura) v Austrálii. Incyte zajistí vývoj a výrobu, ST bude řešit registrační záležitosti, lékařské záležitosti, marketing a distribuci.
, /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) today announced an expansion of its existing partnership with Incyte Biosciences International, an affiliate of Incyte (NASDAQ: INCY), to commercialise, distribute, and register ruxolitinib cream (registered as Opzelura® in the U.S. and European Union) in Australia.
Ruxolitinib (1.5%) cream is a novel, topical Janus kinase (JAK) inhibitor.[1] In the U.S., OPZELURA is indicated for the topical treatment of non-segmental vitiligo in adults and pediatric patients 12 years of age and older, as well as for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.[2]
Under the terms of the expanded agreement, Incyte will remain responsible for the development and manufacturing of ruxolitinib cream, while ST will manage regulatory submissions, medical affairs, marketing, and distribution across Australia.
ST Chief Executive Officer, Mr Carlo Montagner, welcomed the addition of ruxolitinib cream to ST's portfolio, marking a key expansion into inflammatory dermatology.
"Our partnership with Incyte began in 2021, and we are pleased to extend this collaboration into dermatology," said Mr Montagner. "Atopic dermatitis and vitiligo are chronic skin conditions that carry a significant physical and psychosocial burden for patients.[3],[4] Bringing ruxolitinib cream to the Australian market aligns with our ongoing commitment to providing innovative therapies for conditions where substantial unmet medical needs remain."
"Our immediate priority will be navigating the local regulatory and reimbursement pathways to ensure eligible Australian patients gain equitable and timely access to this topical treatment," Mr Montagner added.
Incyte Head of International, Lee Heeson, noted that the expanded agreement reinforces the strong operational alignment between the two organisations.
"We are pleased to expand our partnership with Specialised Therapeutics as we work to make ruxolitinib cream available to eligible patients in Australia," said Lee Heeson, Executive Vice President and Head of Incyte International. "ST's proven experience navigating regulatory, medical and commercial pathways across the region makes them a valued partner as we continue to broaden access to our portfolio globally."
ST anticipates progressing regulatory and reimbursement submissions for OPZELURA with Australian healthcare authorities in due course.
– ENDS –
About Specialised Therapeutics
Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and dermatology, although it is not confined to these areas. Additional information can be found at www.stbiopharma.com.
About Ruxolitinib Cream (OPZELURA)
Ruxolitinib cream (OPZELURA) a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA 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 AD in non-immunocompromised patients 2 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.[2]
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 and in adult patients with moderate atopic dermatitis (AD) for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate.[5]
Incyte has worldwide rights for the development and commercialisation of OPZELURA. To date, more than one million patients globally have been treated with OPZELURA.
Incyte chce do roku 2030 zvýšit tržby z byznysu mimo JAKAFI ze zhruba 2 miliard USD na 3 až 4 miliardy USD. Firma sází na rozšíření pipeline a přípravu na vypršení exkluzivity JAKAFI po roce 2029.
Can Incyte Deliver on 447% EPS Forecasts and Pipeline Hype?Incyte NASDAQ: INCY executives outlined a strategy centered on expanding its non-JAKAFI business, advancing a broader late-stage pipeline and preparing for the loss of exclusivity for JAKAFI after 2029.
Chief Executive Officer Bill Meury said the company’s pipeline has changed substantially over the past year, citing proof-of-concept data for its CALR antibody 989 in myelofibrosis and essential thrombocythemia, its KRAS G12D inhibitor in pancreatic cancer, and its TGF-beta-by-PD-1 program in colorectal cancer. He also pointed to phase III data for povorcitinib, which is under FDA review, and the acquisition of Vega Therapeutics and its von Willebrand disease candidate latarcibart.
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5 top healthcare stocks for earnings growth in 2024Meury said Incyte’s core business excluding JAKAFI is annualizing at roughly $2 billion in sales. The company aims to increase that figure to $3 billion to $4 billion by 2030. If its pipeline programs are successfully developed and launched, he said Incyte has the potential to grow at a 15% to 20% compound annual rate from 2030 through 2035.
JAKAFI XR Conversion and MPN Pipeline Meury said the company expects extended-release JAKAFI XR formulary coverage to approach 70% to 80% by year-end. According to Meury, major pharmacy benefit managers and health plans have placed XR on formulary at parity with immediate-release JAKAFI and at a price acceptable to both Incyte and payers.
Argenx's 28% Surge & Promising Product Propel Investor ConfidenceIncyte has projected that 10% to 30% of JAKAFI patients could convert to XR before loss of exclusivity. At the midpoint of that range, Meury said the conversion could preserve nearly $750 million in sales during the transition. He characterized XR as a bridge rather than a primary driver of Incyte’s long-term value.
President and Global Head of R&D Pablo Cagnoni said 989 is already in pivotal development for second-line essential thrombocythemia, while a second-line myelofibrosis study is being implemented. The company plans to provide more details on the myelofibrosis trial design during its next earnings call.
For frontline myelofibrosis, Incyte expects to present data at the American Society of Hematology meeting from a cohort in which roughly two-thirds of patients received 989 monotherapy and one-third received 989 with ruxolitinib. Cagnoni said the data will help determine the design of a planned frontline trial expected to begin in early 2027.
The company is also discussing potential endpoints with the FDA. Cagnoni said Incyte believes measures including hemoglobin, platelets, blasts and spleen size could support a composite endpoint that better reflects disease modification. The company continues to have a “constructive dialogue” with the agency, he said, but retains a path to approve 989 using existing endpoints if necessary.
Incyte also plans to present preclinical data at ASH for a next-generation mutant CALR antibody that Cagnoni said has a longer half-life and greater potency against Type 1 and Type 2 CALR mutations. Separately, the company will present a preclinical package for a next-generation JAK2 V617F inhibitor designed to improve on its discontinued earlier program.
Solid-Tumor Programs Advance At the European Society for Medical Oncology meeting, Incyte plans to provide an update on its KRAS G12D inhibitor, 734, in approximately 50 frontline pancreatic cancer patients treated in combination with either FOLFIRINOX or gemcitabine plus nab-paclitaxel. Cagnoni said the company expects to report strong efficacy data and six-month event-free survival, though progression-free survival is not yet mature.
He said Incyte views its efficacy and safety profile as comparable with that of its nearest competitor, while noting that patients in its study have had approximately 1.6 to 1.8 months longer treatment exposure. A phase III frontline pancreatic cancer study is enrolling and expanding globally, and Incyte plans to pursue an adjuvant pancreatic cancer program.
The company will also present data for 734 plus cetuximab in later-line colorectal cancer. Cagnoni said the response rate exceeded what would be expected from cetuximab alone and that the company intends to discuss a proposed pivotal trial with the FDA.
Incyte’s TGF-beta receptor II-by-PD-1 bispecific, 890, is being studied in microsatellite-stable colorectal cancer. Cagnoni said the drug’s design seeks to target TGF-beta receptor II only when the PD-1 arm is fully engaged, potentially avoiding the toxicity associated with systemic TGF-beta approaches. In a heavily pretreated group of about 100 patients, he said the program produced a 15% response rate with durable responses. The company plans to present data from about 50 frontline patients receiving 890 with FOLFOX and bevacizumab at ESMO, while its phase III trial is enrolling ahead of schedule.
Dermatology and Von Willebrand Disease Meury said povorcitinib could address hidradenitis suppurativa in both pre-biologic and post-biologic populations. He said the company’s open-label extension data from more than 1,200 participants have been reassuring and that the benefit-risk profile differs from that of JAK inhibitors in other settings because of patient selection, dosing and monitoring.
Incyte is preparing a U.S. launch effort that will include a sales organization covering more than 10,000 HS specialists, peer-to-peer programs, consumer advertising and payer-access initiatives. Germany is the company’s initial international target market. Meury also said Incyte expects fourth-quarter data for povorcitinib in prurigo nodularis and for OPZELURA in HS.
On business development, Meury highlighted the Vega acquisition as an example of the company’s preferred approach: acquiring a de-risked, late-stage asset in an area aligned with Incyte’s hematology expertise. Latarcibart uses a different approach to treating von Willebrand disease by modulating anticoagulant protein S. Cagnoni said a database analysis cited by the company estimated that about 30,000 patients with von Willebrand disease could qualify for prophylaxis, while only about 2,000 currently receive it.
Meury said business development remains a priority as Incyte seeks to supplement its internal pipeline, but stressed the importance of deploying capital carefully.
About Incyte (NASDAQ:INCY)Incyte Corporation is a biopharmaceutical company focused on discovering, developing and commercializing medicines for oncology and inflammatory diseases. Founded in 1991 and headquartered in Wilmington, Delaware, the company conducts research in areas including oncology, hematology, immunology and dermatology.
Incyte's commercial portfolio includes Jakafi (ruxolitinib), a treatment for certain myelofibrosis, polycythemia vera and graft-versus-host disease; Opzelura (ruxolitinib) cream for atopic dermatitis and nonsegmental vitiligo; and Pemazyre (pemigatinib) for selected cancers involving abnormal FGFR signaling.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Incyte ve 2. čtvrtletí zvýšila tržby o 38 % na 1,67 miliardy USD a zvedla celoroční výhled tržeb z Opzelury i celkových čistých produktových tržeb. Akcie za poslední měsíc přidaly asi 0,8 %.
It has been about a month since the last earnings report for Incyte (INCY - Free Report) . Shares have added about 0.8% in that time frame, underperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Incyte due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Incyte Corporation before we dive into how investors and analysts have reacted as of late.
Incyte Corporation reported second-quarter 2026 adjusted earnings of $3.09 per share, which beat the Zacks Consensus Estimate of $2.00, primarily due to higher product sales. The company had reported adjusted earnings of $1.57 per share in the year-ago quarter.
Total revenues in the second quarter were $1.67 billion, which grew 38% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.46 billion.
All percentages mentioned below are on a reported basis.
INCY's Q2 Results in Detail
Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), amounted to $816.7 million, up 7% from the year-ago quarter, owing to a 9% increase in paid demand and growth across all indications. Jakafi's sales beat the Zacks Consensus Estimate of $798 million.
Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $449.7 million in sales, which rose 173% year over year, beating the Zacks Consensus Estimate of $277.8 million. The massive uptick was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura, as well as by increased patient demand in both approved indications.
The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $49.9 million, which significantly increased from the year-ago quarter and beat the Zacks Consensus Estimate of $43.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Net product revenues of Iclusig were $34.4 million, up 5% year over year. The figure missed the Zacks Consensus Estimate of $35.5 million. Pemazyre generated $23.4 million in sales, reflecting a year-over-year increase of 6%. The figure surpassed the Zacks Consensus Estimate of $22.4 million.
Minjuvi's revenues totaled $53.7 million, up 72% year over year. The figure beat the Zacks Consensus Estimate of $50.6 million. Incyte gained exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024.
Incyte and partner Syndax Pharmaceuticals obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. The candidate was approved under the brand name Niktimvo. The drug is Incyte’s second approved treatment for chronic GVHD (third-line) and was launched in the United States during the first quarter of 2025. The drug recorded $60.3 million in sales in the second quarter of 2026, up 67% on a year-over-year basis, driven by strong uptake, but missed the Zacks Consensus Estimate of $63.8 million.
Shares of Incyte have rallied 20.3% year to date compared with the industry’s 2% growth.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi in ex-U.S. markets. Jakavi royalty revenues from Novartis for commercialization in ex-U.S. markets rose 13% to $124.2 million. Jakavi royalties beat the Zacks Consensus Estimate of $117 million.
Incyte also receives royalties from the sales of Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small-cell lung cancer. Its partner, Novartis, has exclusive worldwide development and commercialization rights for Tabrecta. Royalty revenues from the drug’s sales amounted to $6.7 million, up 1% year over year. The reported figure missed the Zacks Consensus Estimate of $7.1 million.
Olumiant’s (baricitinib) product royalty revenues from Eli Lilly totaled $38.5 million, up 15% year over year. The figure beat the Zacks Consensus Estimate of $36.9 million. Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases.
Adjusted research and development (R&D) expenses totaled $478.8 million, up 5% year over year. This increase was primarily due to continued investment in late-stage development assets.
Adjusted selling, general and administrative (SG&A) expenses were $323.6 million, up 6% from the prior-year quarter’s number, primarily due to increased consumer marketing and pre-launch activities.
INCY’s cash, cash equivalents and marketable securities amounted to $4.5 billion as of June 30, 2026, compared with $4 billion recorded as of March 31, 2026.
INCY Raises 2026 Guidance
While Incyte continues to expect Jakafi revenues in the range of $3.22-$3.27 billion in 2026, it now expects Opzelura net product revenues to be in the range of $1.05-$1.1 billion, up from the previously guided range of $750-$790 million. Net product revenues for 2026 are now expected to be in the range of $5.13-$5.26 billion, up from the previously guided range of $4.77-$4.94 billion.
Total adjusted R&D expenses and SG&A expenses for 2026 are now expected in the range of $4.625-$4.695 billion compared with the previous guidance of $3.205-$3.375 billion.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates revision.
The consensus estimate has shifted -298.32% due to these changes.
VGM ScoresAt this time, Incyte has a strong Growth Score of A, though it is lagging a lot on the Momentum Score front with an F. However, the stock was allocated a score of B on the value side, putting it in the second quintile for value investors.
Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Incyte has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Incyte ve 2. čtvrtletí zvýšila výnosy na 1,67 miliardy USD a čisté tržby na 1,49 miliardy USD, zároveň zvedla celoroční výhled čistých tržeb na 5,26 miliardy USD.
Biopharmaceutical company Incyte Corporation (INCY) gets Big Money support to gain 23% so far in 2026.
In this article:INCY
-0.33%
INCY discovers, develops, and sells proprietary therapeutics focused on hematology, oncology, inflammation, and autoimmunity. The company’s second-quarter fiscal 2026 earnings report, INCY showed $1.67 billion in quarterly revenue (a 38% year-over-year gain) led by Jakafi ($817 million) and Opzelura ($450 million), net sales of $1.49 billion (a 40% rise), and raised annual net sales guidance to a high end of $5.26 billion.
It’s no wonder INCY shares are up 23% this year, and they could rise more. MoneyFlows data shows how Big Money investors are again betting heavily on the stock.
Incyte Attracts Big Money Institutional volumes reveal plenty. In the last year, INCY has endured some choppiness. But it’s once again enjoying strong investor demand, which we believe to be institutional support.
Each green bar signals unusually large volumes in INCY shares. They reflect our proprietary inflow signal, pushing the stock higher:
INCY is up 48.4% in a year thanks to institutional support – green inflow signals came in bursts throughout the period. Source: www.moneyflows.com Plenty of health care names are under accumulation right now. But there’s a powerful fundamental story happening with Incyte.
Incyte Fundamental Analysis Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, INCY has had strong sales and earnings growth:
Also, EPS is estimated to ramp higher this year by +106.4%.
Now it makes sense why the stock has been generating Big Money interest. INCY has a track record of strong financial performance.
Marrying great fundamentals with MoneyFlows software has found some big winning stocks over the long term.
Incyte has been a top-rated stock at MoneyFlows for years. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis.
In the last year, INCY has drawn five outlier inflow signals and gained 48.4%. The blue bars below show when INCY was a top pick on the Outlier 20 report…institutions can move shares higher:
Five outlier inflow signals have sent INCY shares higher – it’s attracted 30 outlier inflow signals since 2000. Source: www.moneyflows.com Tracking unusual volumes reveals the power of money flows.
This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward.
Incyte Price Prediction The INCY action isn’t new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio.
Disclosure: the author holds no position in INCY at the time of publication.
If you are a Registered Investment Advisor (RIA) or are a serious investor, take your investing to the next level and follow our free weekly MoneyFlows insights.
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Lucas is a well-versed equity investor and educator. He currently is co-founder of research and analytics firm, MAPsignals.com, which focuses on finding outlier stocks by following the Big Money.
Specialised Therapeutics uvedla, že Minjuvi v kombinaci s rituximabem a lenalidomidem je nově hrazen na PBS pro dospělé s relabujícím nebo refrakterním folikulárním lymfomem. Ve studii inMIND snížil riziko progrese, relapsu nebo úmrtí o 57 %.
Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen listed on the Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1],[2] In the pivotal Phase 3 inMIND clinical trial, patients with R/R FL receiving the Minjuvi combination regimen experienced a significant improvement in progression-free survival, with a 57% reduction in the risk of disease progression, relapse or death, compared with placebo plus lenalidomide and rituximab.[3] Follicular lymphoma is the second most common non-Hodgkin lymphoma (NHL), with over 10,000 Australians living with the disease and approximately 1,500 Australians diagnosed each year.[4],[5] , /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the listing of Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1] This milestone follows the Australian registration of Minjuvi for R/R FL by the Therapeutic Goods Administration (TGA) in April 2026, via the Project Orbis process.[6]
The PBS listing of Minjuvi marks the availability of the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this group of patients.[1],[2] Effective 1 August 2026, eligible patients with FL who have experienced relapses or disease progression on existing therapies will now have equitable access to a new treatment option for this difficult-to-treat condition.[1]
"As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia," said Carlo Montagner, ST Chief Executive Officer. "After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay."
ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore.
Minjuvi is a CD19 targeting immunotherapy that works within a patient's immune system to help find and eliminate malignant B-cells.[7] In combination with rituximab and lenalidomide, Minjuvi delivers a complementary immune-mediated approach that helps control disease progression and supports improved long-term outcomes for patients with follicular lymphoma.[7]
The PBS reimbursement underscores the growing recognition of innovative immunotherapy-based treatment strategies in follicular lymphoma and reinforces ST's commitment to improving access to life-changing therapies for patients across the Asia-Pacific region.
"While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment," said Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne. "Today's PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for R/R FL."
Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting.[7] Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.[7]
"Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community," said Sharon Winton, Chief Executive Officer of Lymphoma Australia. "As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families."
The PBS listing of Minjuvi for R/R FL means these patients will now have equitable access to a new targeted immunotherapy combination treatment when they need it. It is important that patients with R/R FL speak with their doctor to understand the most suitable treatment option available for them.
For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.
PBS Information:
This medicine is listed on the Pharmaceutical Benefits Scheme (PBS) — AUTHORITY REQUIRED. Refer to the PBS Schedule www.pbs.gov.au for full authority information.
Important Safety Information on Minjuvi[7]
Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.
Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded. In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).
Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.
Ends.
About Minjuvi® (tafasitamab)
Minjuvi® (tafasitamab) is a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody. Minjuvi 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).[7] Incyte licenses exclusive worldwide rights to develop and commercialise Minjuvi from Xencor, Inc.
In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT.
Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorisation from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.
In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory DLBCL. Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory FL (2L+ FL).
In Australia, Minjuvi® (tafasitamab) is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).[7]
▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA.[7]
XmAb® is a registered trademark of Xencor, Inc.
Monjuvi and Minjuvi are registered trademarks of Incyte.
About the inMIND Study[3]
A global, double-blind, randomised, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years), including 548 participants with R/R FL. 54 Australians participated in the study across 12 local trial sites around the country.
The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.
The clinical trial met its primary endpoint, with the data demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56].
Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of Minjuvi to lenalidomide in combination with rituximab. The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.
About Specialised Therapeutics
Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas.
Additional information can be found at www.stbiopharma.com.
REFERENCES:
[1]. Australian Government, Department of Health, Disability and Ageing. PBS Schedule: PBS Publications & Downloads [August 2026].
[2]. NCCN Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. Version 3.2026.
[3]. Sehn LH, et al. Lancet. 2026 Jan 10;407(10524):133-146.
[4]. Lymphoma Australia. Types of Lymphoma: Follicular Lymphoma. [Accessed July 2026].
[5]. Australian Institute of Health and Welfare (AIHW). Cancer Data in Australia: Prevalence Data Workbook – Blood Cancer Histology. [Accessed July 2026].
[6]. Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG): MINJUVI (tafasitamab). [Accessed July 2026].
[7]. MINJUVI Australian Product Information. 20 April 2026.
Incyte ve 2. čtvrtletí zvýšila čisté tržby z produktů na 1,49 miliardy USD, meziročně o 40 %, a zvedla celoroční výhled tržeb na 5,13 až 5,26 miliardy USD.
Can Incyte Deliver on 447% EPS Forecasts and Pipeline Hype?Incyte NASDAQ: INCY reported second-quarter 2026 net product sales of $1.49 billion, up 40% from a year earlier, supported by demand growth across its marketed portfolio and a one-time non-cash benefit tied to the resolution of a CMS matter involving OPZELURA.
Excluding the $246 million one-time benefit, total net sales increased 17% year over year, Chief Executive Officer Bill Meury said on the company’s earnings call. Meury said every marketed product recorded year-over-year growth in both U.S. and international markets.
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5 top healthcare stocks for earnings growth in 2024The company raised its full-year 2026 total net sales outlook to a range of $5.13 billion to $5.26 billion. It also increased OPZELURA sales guidance and narrowed and raised its outlook for the hematology and oncology portfolio.
Jakafi Remains Foundational as Other Products Expand Jakafi second-quarter sales were $817 million, up 7% from the prior-year period. Prescription demand increased 9% across myelofibrosis, polycythemia vera and graft-versus-host disease, with polycythemia vera serving as the largest growth driver, Meury said.
Argenx's 28% Surge & Promising Product Propel Investor ConfidenceIncyte recently launched Jakafi XR, an extended-release version of the product. Jakafi XR generated $10 million in second-quarter sales, primarily from initial inventory build. The company expects full-year XR sales of approximately $40 million to $50 million, included within its broader Jakafi guidance.
Mohamed Issa, executive vice president and head of U.S. Commercial, said payer reimbursement has begun and several major insurers have placed Jakafi XR on formulary. Incyte is targeting 50% to 70% formulary coverage by year-end and expects the extended-release product to represent roughly 3% to 5% of demand by December.
Sales from Incyte’s business excluding Jakafi totaled $671 million, up 127% year over year. Excluding the one-time OPZELURA benefit, the segment grew 44%. Meury said the company remains on track toward its objective of generating $3 billion to $4 billion in net sales from the core business excluding Jakafi by 2030.
OPZELURA Benefit Lifts Guidance OPZELURA contributed $450 million in second-quarter sales, including $204 million in net product sales and the $246 million non-cash benefit associated with the CMS settlement and the reversal of previously accrued balances related to Medicaid rebate litigation.
U.S. OPZELURA sales excluding the one-time benefit rose 22% to $161 million. Prescription volume increased 26%, compared with 21% growth for the overall market, according to Meury. The company said OPZELURA captured 46% of branded topical new prescription volume.
The CMS resolution improved the product’s average selling price and gross-to-net profile, Meury said. He said the gross-to-net rate moved from the low 60% range to the high 50% range. Incyte now expects $1.05 billion to $1.10 billion in full-year OPZELURA sales, including an estimated $300 million to $310 million impact from the settlement.
International OPZELURA sales rose 34% to $43 million. The company expects a final European Commission decision for OPZELURA in moderate atopic dermatitis during the third quarter after receiving a positive opinion from the Committee for Medicinal Products for Human Use in June.
Hematology and Oncology Portfolio Gains Momentum Hematology and oncology sales increased 69% to $222 million. Niktimvo generated $60 million in sales, up 67%, with more than 300 new patients initiating therapy during the quarter and more than 1,200 patients treated. Incyte said it holds approximately one-third of the third-line-and-beyond market.
MONJUVI sales increased 72% to $54 million, driven primarily by uptake in follicular lymphoma in international markets, including Japan following a recent approval and launch. ZYNYZ sales rose fourfold to $50 million, with the company reporting more than a 40% share in first-line squamous cell carcinoma of the anal canal in the U.S. 12 months after launch.
Incyte narrowed and raised its 2026 hematology and oncology sales forecast to $860 million to $890 million.
Pipeline Updates Include Vega Acquisition and Program Discontinuation The company said it has advanced 13 of 15 planned pivotal studies, with the remaining two expected to begin by year-end. Regulatory reviews are ongoing for povorcitinib in hidradenitis suppurativa and tafasitamab in newly diagnosed diffuse large B-cell lymphoma, with potential approvals and launches beginning later in 2026 and extending into 2027.
Incyte also acquired Vega Therapeutics, adding latarcibart, a phase III treatment candidate for von Willebrand disease. Pablo Cagnoni, Incyte’s president and global head of research and development, said data from the VIVID-3 study showed an 81% median reduction in annualized bleeding rate across patients with different von Willebrand disease subtypes and bleeding types. Top-line data from the phase III VIVID-6 trial are expected by early 2029.
Meanwhile, Incyte discontinued development of its 058 program targeting JAK2 V617F in myeloproliferative neoplasms. Cagnoni said the company concluded that the molecule did not demonstrate the profile needed to be a differentiated therapy, though Incyte continues to view JAK2 V617F as an important target and is prioritizing next-generation programs.
The company plans to present expanded early-stage data for its KRAS G12D inhibitor, INCB161734, its TGF-beta receptor 2 by PD-1 bispecific antibody, and its CDK2 inhibitor at the European Society for Medical Oncology Congress in October.
Expenses Rise With Development Investment and Vega Transaction GAAP operating expenses were $976 million in the quarter, up 42% from a year earlier. Incyte said the comparison reflected a lower prior-year expense base following a $242 million Novartis settlement in the second quarter of 2025. Excluding that favorable adjustment, operating expenses rose 5%.
GAAP research and development expense increased 4% to $517 million, while selling, general and administrative expense rose 6% to $352 million, driven in part by pre-launch activities for povorcitinib. The company ended the quarter with $4.5 billion in cash and cash equivalents, including the impact of the Vega acquisition completed in July.
Incyte raised its 2026 GAAP R&D and SG&A expense outlook to $4.915 billion to $4.995 billion. The revised forecast includes approximately $1.27 billion related to the Vega transaction’s upfront in-process research and development payment and transaction costs, as well as roughly $50 million for continued phase III development of latarcibart.
About Incyte (NASDAQ:INCY)Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company's research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.
The company's flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Incyte oznámila za 2. čtvrtletí zisk 3,09 USD na akcii a tržby 1,67 miliardy USD, obojí nad odhady. Zisk byl meziročně vyšší než 1,57 USD na akcii a tržby vzrostly z 1,22 miliardy USD.
Incyte (INCY - Free Report) came out with quarterly earnings of $3.09 per share, beating the Zacks Consensus Estimate of $2 per share. This compares to earnings of $1.57 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +54.50%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $1.38 per share when it actually produced earnings of $1.81, delivering a surprise of +31.16%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Incyte, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.67 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 14.71%. This compares to year-ago revenues of $1.22 billion. The company has topped consensus revenue estimates four times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Incyte shares have added about 20.4% since the beginning of the year versus the S&P 500's gain of 8.3%.
What's Next for Incyte?While Incyte has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Incyte was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.04 on $1.47 billion in revenues for the coming quarter and $7.87 on $5.73 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Another stock from the same industry, Keros Therapeutics, Inc. (KROS - Free Report) , has yet to report results for the quarter ended June 2026.
This company is expected to post quarterly loss of $1.25 per share in its upcoming report, which represents a year-over-year change of -64.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Keros Therapeutics, Inc.'s revenues are expected to be $0.35 million, down 98.1% from the year-ago quarter.
Incyte očekává výsledky za 2. čtvrtletí s odhadem tržeb 1,40 miliardy USD a zisku 1,85 USD na akcii. Firma může těžit ze silného prodeje Jakafi, růstu Opzelury a jednorázového účetního přínosu asi 246 milionů USD.
Key Takeaways INCY is set to report Q2 results with revenue estimates at $1.40B and earnings expected at $1.85 per share.INCY may benefit from strong Jakafi demand, higher royalties and Opzelura growth with a one-time Q2 benefit.Incyte's newer products, including Niktimvo and Monjuvi, are expected to add to second-quarter revenues. Incyte Corporation (INCY - Free Report) is expected to beat expectations when it reports second-quarter 2026 earnings on July 28, before the opening bell. The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $1.40 billion, while the same for earnings is pinned at $1.85 per share.
Let’s see how things might have shaped up before the announcement.
Factors Likely to Influence INCY's Q2 ResultsIncyte primarily derives product revenues from the sales of its lead drug, Jakafi (ruxolitinib), in the United States, as well as from the sales of other marketed drugs. Its momentum is likely to have continued on the back of strong Jakafi sales, a first-in-class, selective JAK1/JAK2 inhibitor, in all approved indications (polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease [GvHD]).
The Zacks Consensus Estimate for Jakafi's second-quarter sales is pegged at $796.5 million.
Incyte also earns product royalty revenues from Novartis (NVS - Free Report) for the commercialization of Jakafi in ex-U.S. markets.
While Incyte markets Jakafi in the United States, Novartis markets the same drug as Jakavi outside the United States. INCY is expected to have received higher royalties from NVS in the to-be-reported quarter due to potentially higher Jakavi sales.
Year to date, Incyte shares have gained 18.1% compared with the industry’s 1.3% growth.
Image Source: Zacks Investment Research
Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
In the to-be-reported quarter, Opzelura (ruxolitinib cream) sales are expected to have been driven by continued growth in new patient starts and refills in the United States, for both its approved indications, atopic dermatitis and vitiligo. Incyte's second-quarter results are expected to benefit from its recent settlement with the CMS regarding Medicaid rebate rules for Opzelura. The agreement eliminates potential liabilities related to the application of line extension regulations, leading to a one-time, non-cash benefit of approximately $246 million in the second quarter from the reversal of previously accrued balances. The settlement should also improve Opzelura's gross-to-net performance going forward, and management is expected to update its financial guidance to reflect the impact.
The Zacks Consensus Estimate for Opzelura’s second-quarter sales is pegged at $214.7 million.
While Jakafi’s sales and royalties are the key catalysts for Incyte’s revenue growth, sales of other drugs like Minjuvi, Pemazyre and Iclusig, and Olumiant’s royalties from Eli Lilly (LLY - Free Report) are also likely to have contributed to Incyte’s top line. INCY has a collaboration agreement with LLY for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to Eli Lilly. It is approved for several types of autoimmune diseases.
Incyte acquired exclusive global rights to Monjuvi/Minjuvi (tafasitamab), initially approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma, from MorphoSys in 2024. Last year, the FDA approved Monjuvi for relapsed or refractory follicular lymphoma, expanding its label and boosting sales. Minjuvi also secured approvals for this indication in the EU and Japan in 2025.
The Zacks Consensus Estimate for Iclusig, Minjuvi/Monjuvi and Pemazyre’s second-quarter sales is pegged at $35.5 million, $50.6 million and $22.4 million, respectively. Incremental sales from Zynyz, too, are expected to have boosted Incyte’s revenues in the to-be-reported quarter.
Incyte and partner Syndax launched Niktimvo (axatilimab-csfr) in the United States in early 2025 after FDA approval for chronic graft-versus-host disease (cGvHD) patients who have failed at least two prior systemic therapies. Niktimvo is Incyte's second approved treatment for cGvHD (third-line). The Zacks Consensus Estimate for Niktimvo’s second-quarter sales is pegged at $63.5 million.
Higher research and development expenses, as well as increased selling, general and administrative costs, are likely to have escalated operating expenses in the second quarter of 2026.
INCY's Earnings Surprise HistoryIncyte has a mixed history of earnings surprises. The company beat earnings estimates in three of the trailing four quarters, while missing the same on the remaining occasion, delivering an average surprise of 18.26%. In the last reported quarter, INCY posted an earnings surprise of 31.16%.
Earnings Whispers for INCY StockOur proven model predicts an earnings beat for INCY this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat, which is the case here, as you will see below.
INCY’s Earnings ESP: Incyte’s Earnings ESP is +18.47% as the Most Accurate Estimate currently stands at $2.19, higher than the Zacks Consensus Estimate, which is pegged at $1.85. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
INCY’s Zacks Rank: INCY has a Zacks Rank #3 at present.
Another Stock With a Favorable CombinationHere is a stock worth considering from the healthcare space, as our model shows that this, too, has the right combination of elements to beat on earnings this reporting cycle.
ACADIA Pharmaceuticals (ACAD - Free Report) has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of ACAD have lost 7% year to date. The company’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 20.83%. Acadia is scheduled to report second-quarter results on Aug. 4.
Incyte uvedla, že latarcibart v malé studii u von Willebrandovy choroby snížil medián roční míry krvácení o 81 % napříč všemi typy onemocnění. Léčba byla také dobře snášena a nyní se testuje v pivotální fázi 3 VIVID-6.
- Treatment with latarcibart led to an 81% median reduction in annualized bleeding rate (ABR) across all bleeding categories and patient types with von Willebrand disease (VWD)
- Latarcibart, administered via a once monthly subcutaneous dosing regimen, was shown to be safe and well tolerated over multiple doses in this study
- Pivotal Phase 3 VIVID-6 trial evaluating latarcibart’s potential to be the first targeted therapy for VWD is currently enrolling
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq: INCY) today announced complete safety and efficacy data from all patients (n=16) enrolled in the Phase 1/2 multidose study of VGA039 (latarcibart), a novel, Protein S-targeting, investigational monoclonal antibody for patients with von Willebrand disease (VWD). The data are being shared in an oral presentation today at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH 2026 Congress) in Paris.
“These results continue to build a highly consistent body of evidence supporting latarcibart as a significant potential treatment advancement for patients with VWD,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of R&D.
Share Latarcibart modulates Protein S to improve hemostasis, potentially enhancing the body’s ability to prevent or reduce the frequency of bleeding episodes. Latarcibart is in pivotal Phase 3 development for patients with VWD, the most common inherited bleeding disorder. If approved, latarcibart has the potential to be the first, once monthly subcutaneous prophylactic therapy for patients with VWD, offering an important alternative to the frequent intravenous infusions of replacement factor concentrates commonly used in the prophylactic setting today. Given its novel mechanism, latarcibart may also have potential in other bleeding disorders.
“These results continue to build a highly consistent body of evidence supporting latarcibart as a significant potential treatment advancement for patients with VWD,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “This multidose dataset underscores the potential of latarcibart to address the longstanding need for a prophylactic therapy that provides meaningful protection for patients with all types of VWD. We are continuing to enroll the Phase 3 VIVID-6 study as we work toward redefining the standard of routine prophylactic care for patients with VWD.”
As of May 5, 2026, data from all 16 patients enrolled in the Phase 1/2 multidose study were available, and all participants had completed the multidose regimen of six doses of latarcibart, with maintenance doses administered subcutaneously every four weeks. Key data highlights include:
Substantial reductions in ABR (annualized bleeding rate) were seen across study patients, including all VWD types and bleed types, such as serious GI and hemophilia-like joint and muscle bleeds. The median ABR reduction across all VWD types and bleed categories was 81%. In patients switching from prior von Willebrand factor (VWF)-containing prophylaxis (IV infusions multiple times per week), bleed reductions were 75-100%, indicating potential improvement over current standard of care. Among patients not previously receiving IV prophylaxis, 7 had historical ABRs >12, a key eligibility criterion for the Phase 3 VIVID-6 study. In this group, ABR reductions ranged from 46-100%, with nearly all patients (6/7) achieving reductions >73%. Latarcibart treatment resulted in ~86% reduction in VWF-treated breakthrough bleeds, with 70% of patients with prior VWF-treated bleeds not experiencing a VWF-treated breakthrough bleed while on treatment. All participants who entered the study with a substantial bleed burden transitioned to continue receiving latarcibart in the ongoing open-label extension study. Latarcibart once monthly subcutaneous prophylaxis was safe and well tolerated over multiple doses. Three treatment-emergent adverse events (TEAEs) related to latarcibart were reported: two Grade 2 headaches in one patient and one report of Grade 1 injection site reactions. There was also one unrelated serious adverse event of severe gastrointestinal (GI) bleeding in a patient with a history of frequent and severe GI bleeding. “Many people with VWD struggle with bleeding and need more effective and convenient prophylactic treatments. The study results showed treatment with latarcibart delivered consistent and clinically meaningful reductions in bleeding across a diverse group of VWD patients, including patients with all major types of the disease and individuals transitioning from intensive IV prophylaxis,” said Allison Wheeler, M.D., MSCI, Associate Professor of Pediatrics at the University of Washington. “Equally important, the favorable safety profile and once monthly subcutaneous dosing regimen have the potential to substantially reduce treatment burden while providing consistent bleed protection. Together, these findings provide a strong foundation for the Phase 3 study and support latarcibart’s potential as an important new treatment option for patients with VWD.”
More information regarding the ISTH 2026 Congress can be found on the ISTH website: https://www.isthcongress.org/ (Session details: Novel Therapies for Bleeding Disorders, Including VWD and Rare Bleeding Disorders – 2; Publication Number: OC 32.3).
About VGA039 (latarcibart)
VGA039 (latarcibart) is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. Latarcibart has the potential to be a universal prophylactic therapy for numerous bleeding disorders, starting with all types of von Willebrand disease (VWD) and bleeding sites. As a subcutaneously self-administered investigational antibody therapy with a once monthly dosing regimen, latarcibart has the potential to improve bleeding outcomes, convenience, and quality of life for patients.
Latarcibart has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). Latarcibart has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of latarcibart as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.
Incyte acquired VGA039 (latarcibart) in July 2026 as part of its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics LLC.
About the VIVID Clinical Program
The VIVID multinational clinical program consists of multiple clinical trials, from Phase 1 to 3, in both a platform multi-phase protocol (VIVID-1-5) and a standalone Phase 3 protocol (VIVID-6) evaluating the safety and efficacy of VGA039 in VWD. The VIVID clinical program is active across 6 continents and designed to support future registrational filings globally.
About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). People with VWD may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the data to be presented by Incyte at the ISTH 2026 Congress; Incyte’s expectations regarding VGA039’s (latarcibart’s) clinical development and regulatory approvals; the potential and promise latarcibart offers patients with bleeding disorders, including the potential to be the first once monthly subcutaneous prophylactic therapy for patients with VWD, its potential improvement over current standards of care for patients with VWD and other bleeding disorders, and its potential ability to address significant unmet need, reduce treatment burden and improve quality of life; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including results from clinical trials of and the sufficiency of clinical trial data for latarcibart, as well as Incyte’s other products and product candidates, to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for latarcibart, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Three outlier inflow signals push biopharmaceutical firm Incyte Corporation (INCY) up 71% in a year.
INCY discovers, develops, and sells proprietary therapeutics focused on hematology, oncology, inflammation, and autoimmunity. The company’s first-quarter fiscal 2026 earnings report, INCY showed $1.27 billion in quarterly revenue (a 21% year-over-year gain) led by Jakafi ($758 million) and Opzelura ($143 million), net sales of $1.1 billion (a 20% rise), and offered annual net sales guidance of up to $4.94 billion, representing a 13% jump from the prior year. To expand its hematology business, the company also recently acquired a therapeutics firm focused on bleeding disorders.
It’s no wonder INCY shares are up 15% this year, and they could rise more. MoneyFlows data shows how Big Money investors are again betting heavily on the stock.
Institutions Buying Incyte Institutional volumes reveal plenty. In the last year, INCY has endured some choppiness. But it’s once again enjoying strong investor demand, which we believe to be institutional support.
Each green bar signals unusually large volumes in INCY shares. They reflect our proprietary inflow signal, pushing the stock higher:
Source: www.moneyflows.com Plenty of health care names are under accumulation right now. But there’s a powerful fundamental story happening with Incyte.
Incyte Fundamental Analysis Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, INCY has had strong sales and earnings growth:
Also, EPS is estimated to ramp higher this year by +16.3%.
Now it makes sense why the stock has been generating Big Money interest. INCY has a track record of strong financial performance.
Marrying great fundamentals with MoneyFlows software has found some big winning stocks over the long term.
Incyte has been a top-rated stock at MoneyFlows for years. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis.
In the last year, INCY has drawn three outlier inflow signals and is up 70.7%. The blue bars below show when INCY was a top pick on the Outlier 20 report…Big Money support matters:
Source: www.moneyflows.com Tracking unusual volumes reveals the power of money flows.
This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward.
Incyte Price Prediction The INCY action isn’t new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio.
Disclosure: the author holds no position in INCY at the time of publication.
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