Full Press Release Details
Incyte Reports Third Quarter 2025 Financial Results and Provides Business Updates
Total revenues of $1.37 billion in the third quarter of 2025, reflecting 20% growth compared to the third quarter of 2024
Jakafi (ruxolitinib) net product revenue of $791 million, an increase of 7% compared to the same period in 2024
Opzelura (ruxolitinib) cream net product revenue of $188 million, an increase of 35% compared to the prior year period
Hematology-Oncology portfolio net product revenues of $171 million, including Niktimvo (axatilimab-csfr) net revenue of $46 million
Raises 2025 full year net product revenue guidance to $4.23 - $4.32 billion
Conference Call and Webcast Scheduled Today at 8 00 a.m. ET
WILMINGTON, Del. - October 28, 2025 - Incyte (Nasdaq INCY) today reported financial results for the third quarter of 2025 and provided a business update.
"Our third-quarter results demonstrate strong growth across our product portfolio, with net product revenues increasing 19% year-over-year, which highlights the momentum in our business and effective commercial execution," said Bill Meury, President and Chief Executive Officer, Incyte. "We are taking a deliberate approach to pipeline prioritization. We are actively reviewing our R D efforts and focusing on high-value programs that are scientifically differentiated, address unmet medical needs, and have the potential to significantly drive Incyte's next phase of growth.
Third Quarter 2025 Results
Total revenues Total revenues were $1.37 billion, an increase of 20% compared to the third quarter of 2024, primarily driven by an increase in total net product revenues. Total net product revenue for the third quarter of 2025 was $1.15 billion, an increase of 19%. The increase was primarily related to patient demand for Jakafi (ruxolitinib) across all indications and strong uptake of the initial launch of Niktimvo (axatilimab-csfr).
Cost of product revenues GAAP and non-GAAP cost of product revenues were $99.0 million and $92.7 million, an increase of 15% and 16%, respectively, compared to the prior year period.
Research and development (R D) expenses GAAP and non-GAAP R D expenses were $506.6 million and $467.0 million, a decrease of 12% and 11%, respectively, compared to the prior year period.
Selling, general and administrative (SG A) expenses GAAP and non-GAAP SG A expenses were $329.1 million and $308.0 million, an increase of 6% and 11%, respectively, compared to the prior year period.
Cash, cash equivalents and marketable securities position As of September 30, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.9 billion and $2.2 billion, respectively.
Full-year 2025 Financial Guidance
The Company is raising its full-year 2025 net product revenue guidance to $4.23 - $4.32 billion to account for higher demand for Jakafi and other hematology and oncology marketed products. The update includes raised guidance for Jakafi to $3.050 - $3.075 billion, as well as other hematology and oncology marketed products to $550 - $575 million. The Opzelura (ruxolitinib) cream revenue guidance of $630 - $670 million is maintained.
The Company reiterates its guidance for GAAP and non-GAAP cost of product revenues, R D, and SG A expenses for full year 2025, which reflects the continued investment in mid- and late-stage clinical development programs and commercial capabilities.
Key Business Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD)
The Company is on track to submit ruxolitinib extended-release (XR) bioequivalence data to the U.S. Food and Drug Administration (FDA) in the fourth quarter.
Results from the Phase 1 trial evaluating INCA033989, an investigational mutant calreticulin (mutCALR) selective monoclonal antibody, in mutCALR positive patients with myelofibrosis (MF) are expected in the second half of 2025. The Phase 1 results will include safety and efficacy data evaluating INCA033989 as a monotherapy in patients who are resistant, refractory or intolerant to JAK inhibitor treatment, as well as data evaluating INCA033989 as a combination therapy with ruxolitinib in patients who are exhibiting a suboptimal response to ruxolitinib monotherapy.
In October, results from the Phase 1 trial evaluating INCA33890 (TGFBR2xPD-1 bispecific antibody) in solid tumors were presented at the European Society for Medical Oncology (ESMO) Congress. In the trial, INCA33890 demonstrated a manageable tolerability profile and clinical efficacy across multiple tumors, including microsatellite stable colorectal cancer (MSS CRC) patients with and without active liver metastases. Based on these initial findings, the Company plans to initiate a registrational program evaluating INCA33890 in MSS CRC in 2026.
Preliminary results from the Phase 1 trial evaluating INCB161734 (KRASG12D selective inhibitor) were presented at the ESMO Congress in October. In the trial, INCB161734 demonstrated a manageable safety profile and clinical efficacy in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) patients with a KRASG12D mutation. Evaluation of INCB161734 in PDAC patients as a monotherapy, and in combination with chemotherapy, is ongoing and will support potential future development efforts.
A Phase 2 trial evaluating INCB123667 (CDK2i) in patients with platinum-resistant ovarian cancer (PROC) with Cyclin E1 overexpression was initiated in the third quarter.
The Phase 3 study evaluating tafasitamab (Monjuvi ) as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing, with data anticipated around year-end 2025.
Inflammation and Autoimmunity (IAI)
In September, the FDA approved the supplemental New Drug Application (sNDA) for Opzelura for pediatric atopic dermatitis (AD). Opzelura is now indicated for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
In October, Phase 3 results from the TRuE-AD4 trial evaluating Opzelura in patients with moderate AD were presented at the International Symposium on Atopic Dermatitis (ISAD). Results from the study demonstrated that by Week 8, treatment with Opzelura significantly improved the clinical signs of AD, rapidly improved itch, improved quality of life measures and was well tolerated in adults with moderate AD who had an inadequate response, intolerance or contraindication to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
The Company anticipates filing a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU) by year-end 2025.
In September, longer-term data for povorcitinib were presented at the European Association of Dermatology and Venereology (EADV) which demonstrated continued clinically meaningful and statistically significant improvements in patients with active moderate to severe hidradenitis suppurativa (HS).
Regulatory submissions for povorcitinib in moderate to severe HS in the EU and the U.S. are anticipated by year end 2025 and early 2026, respectively.
Data from the Phase 3 studies evaluating povorcitinib in prurigo nodularis (PN) and vitiligo, as well as data from the Phase 2 proof-of-concept trial in asthma, are anticipated in 2026.
Corporate and Business Development Updates
The Company strengthened its executive leadership team through the appointment of Soni Basi as Executive Vice President and Chief Human Resources Officer and Dave Gardner as Executive Vice President and Chief Strategy Officer in the third quarter.
Based on ongoing pipeline prioritization efforts, the Company has paused further development of the INCA034460 (anti-CD122) and INCB57643 (BET inhibitor) programs, as well as the development of povorcitinib in chronic spontaneous urticaria (CSU).
The Company announced a strategic partnership with Enable Injections, Inc., to develop and commercialize specific assets in Incyte's portfolio, including INCA033989, with Enable's enFuse on-body delivery system. Under the terms of the agreement, Incyte will obtain a worldwide, exclusive license to use the enFuse technology with INCA033989 in essential thrombocythemia (ET) and MF, with the potential to expand to additional assets and indications.
2025 Third Quarter Financial Results
The financial measures presented in this press release for the three and nine months ended September 30, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte's GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company's business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company's core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company's core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte's operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors' ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Total GAAP revenues | $ | 1,365,980 | $ | 1,137,871 | $ | 3,634,407 | $ | 3,062,519 | |||||||
| Total GAAP operating income (loss) | 443,518 | 146,085 | 1,179,000 | (240,147) | |||||||||||
| Total Non-GAAP operating income | 498,296 | 255,236 | 1,164,516 | 37,618 | |||||||||||
| GAAP net income (loss) | 424,169 | 106,456 | 987,371 | (168,597) | |||||||||||
| Non-GAAP net income (loss) | 455,972 | 209,651 | 997,358 | (53,762) | |||||||||||
| GAAP basic EPS | $ | 2.17 | $ | 0.55 | $ | 5.08 | $ | (0.80) | |||||||
| Non-GAAP basic EPS | $ | 2.33 | $ | 1.09 | $ | 5.13 | $ | (0.25) | |||||||
| GAAP diluted EPS 1 | $ | 2.11 | $ | 0.54 | $ | 4.95 | $ | (0.80) | |||||||
| Non-GAAP diluted EPS 1 | $ | 2.26 | $ | 1.07 | $ | 5.00 | $ | (0.25) |
1.All stock options and stock awards were excluded from the diluted share calculation for the nine months ended September 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position.
(unaudited, in thousands)
| Three Months Ended September 30, | % Change (as reported) | % Change (constant currency) 1 | Nine Months Ended September 30, | % Change (as reported) | % Change (constant currency) 1 | ||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||
| Net product revenues | |||||||||||||||||||||||||
| Jakafi | $ | 791,071 | $ | 741,181 | 7 | % | NA | $ | 2,264,271 | $ | 2,018,993 | 12 | % | NA | |||||||||||
| Opzelura | 187,968 | 139,272 | 35 | % | 33 | % | 471,172 | 346,691 | 36 | % | 35 | % | |||||||||||||
| Iclusig | 37,582 | 29,745 | 26 | % | 19 | % | 99,855 | 86,950 | 15 | % | 11 | % | |||||||||||||
| Pemazyre | 22,741 | 20,661 | 10 | % | 9 | % | 63,373 | 58,606 | 8 | % | 8 | % | |||||||||||||
| Minjuvi Monjuvi | 41,990 | 31,439 | 34 | % | 32 | % | 102,672 | 86,429 | 19 | % | 18 | % | |||||||||||||
| Niktimvo | 45,830 | - | NM | NA | 95,597 | - | NM | NA | |||||||||||||||||
| Zynyz | 22,674 | 694 | 3,167 | % | NA | 34,604 | 1,812 | 1,810 | % | NA | |||||||||||||||
| Total net product revenues | 1,149,856 | 962,992 | 19 | % | 19 | % | 3,131,544 | 2,599,481 | 20 | % | 20 | % | |||||||||||||
| Royalty revenues | |||||||||||||||||||||||||
| Jakavi | 125,645 | 115,741 | 9 | % | 4 | % | 327,504 | 304,653 | 8 | % | 5 | % | |||||||||||||
| Olumiant | 37,111 | 34,796 | 7 | % | 4 | % | 101,393 | 97,087 | 4 | % | 5 | % | |||||||||||||
| Tabrecta | 6,513 | 5,928 | 10 | % | NA | 19,558 | 16,460 | 19 | % | NA | |||||||||||||||
| Other | 1,855 | 414 | 348 | % | NA | 4,408 | 1,838 | 140 | % | NA | |||||||||||||||
| Total royalty revenues | 171,124 | 156,879 | 9 | % | 452,863 | 420,038 | 8 | % | |||||||||||||||||
| Total net product and royalty revenues | 1,320,980 | 1,119,871 | 18 | % | 3,584,407 | 3,019,519 | 19 | % | |||||||||||||||||
| Milestone and contract revenues | 45,000 | 18,000 | 150 | % | 150 | % | 50,000 | 43,000 | 16 | % | 16 | % | |||||||||||||
| Total GAAP revenues | $ | 1,365,980 | $ | 1,137,871 | 20 | % | $ | 3,634,407 | $ | 3,062,519 | 19 | % |
1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results.
Product and Royalty Revenues Total net product revenues for the quarter ended September 30, 2025 increased 19% over the prior year comparative period.
Jakafi net product revenue increased 7% in the third quarter of 2025 versus the prior year comparable period to $791 million, primarily driven by a 10% increase in paid demand across all indications. Jakafi inventory levels were within normal range at the end of the third quarter of 2025.
Opzelura net product revenue increased 35% in the third quarter of 2025 versus the prior year comparable period to $188 million driven by increased patient demand and refills in both atopic dermatitis (AD) and vitiligo. Opzelura inventory levels were within normal range at the end of the third quarter of 2025.
Niktimvo net product revenue increased 27% versus the second quarter of 2025 to $46 million driven by strong uptake following the product launch in the first quarter of 2025.
Total net product and royalty revenues for the quarter ended September 30, 2025 increased 18% over the prior year comparative period.
Operating Expense Summary
(unaudited, in thousands)
| Three Months Ended September 30, | % Change | Nine Months Ended September 30, | % Change | ||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||
| GAAP cost of product revenues | $ | 99,001 | $ | 85,993 | 15 | % | $ | 250,955 | $ | 223,583 | 12 | % | |||||||||
| Non-GAAP cost of product revenues 1 | 92,694 | 79,981 | 16 | % | 232,183 | 205,839 | 13 | % | |||||||||||||
| Contract dispute settlement | - | - | NM | (242,251) | - | NM | |||||||||||||||
| Non-GAAP contract dispute settlement 2 | - | - | NM | - | - | NM | |||||||||||||||
| GAAP research and development | 506,584 | 573,174 | (12 | %) | 1,438,780 | 2,140,814 | (33 | %) | |||||||||||||
| Non-GAAP research and development 3 | 466,950 | 525,343 | (11 | %) | 1,322,605 | 2,002,870 | (34 | %) | |||||||||||||
| GAAP selling, general and administrative | 329,081 | 309,209 | 6 | % | 985,794 | 915,447 | 8 | % | |||||||||||||
| Non-GAAP selling, general and administrative 4 | 308,040 | 277,311 | 11 | % | 915,103 | 817,217 | 12 | % | |||||||||||||
| GAAP (gain) loss on change in fair value of acquisition-related contingent consideration | (12,204) | 23,410 | NM | 22,129 | 23,847 | NM | |||||||||||||||
| Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration | - | - | NM | - | - | NM | |||||||||||||||
| GAAP (profit) and loss sharing under collaboration agreements | - | - | NM | - | (1,025) | NM |
1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2 Non-GAAP contract dispute settlement excludes the contract dispute settlement reached with Novartis.
3 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments.
4 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments.
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended September 30, 2025 were $99.0 million and $92.7 million, an increase of 15% and 16%, respectively, compared to the same period in 2024, primarily driven by growth in net product revenues, the Niktimvo profit share and increased manufacturing related costs, partially offset by the impact of the contract dispute settlement with Novartis.
Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended September 30, 2025 were $506.6 million and $467.0 million, a decrease of 12% and 11%, respectively, compared to the same period in 2024, primarily due to the $100 million milestone payment made to MacroGenics during the third quarter of 2024. Excluding upfront and milestone payments and Escient severance payments, research and development expenses for the quarter ended September 30, 2025 increased 7% compared to the same period in 2024 primarily driven by continued investment in our late stage development assets.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended September 30, 2025 were $329.1 million and $308.0 million, an increase of 6% and 11%, respectively, compared to the same period in 2024, primarily due to international marketing activities to support product launches.
Other Financial Information
Contract dispute settlement In May 2025, Incyte and Novartis entered into a settlement agreement with respect to litigation relating to the duration of royalty payments owed under the Collaboration and License Agreement between Incyte and Novartis. We recorded $242.2 million in contract dispute settlement on the condensed consolidated statement of operations for the nine months ended September 30, 2025, representing the difference between the accrued royalties and the total amount paid by us to Novartis.
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended September 30, 2025, compared to the same period in 2024, was primarily due to updated projections of future net revenues of Iclusig, including the impacts from fluctuations in foreign currency exchange rates.
Operating income GAAP and Non-GAAP operating income for the quarter ended September 30, 2025 increased 204% and 95%, respectively, compared to the same period in 2024, driven primarily by growth in net product revenues and the $100 million milestone payment made to MacroGenics during the third quarter of 2024.
Cash, cash equivalents and marketable securities position As of September 30, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.9 billion and $2.2 billion, respectively.
2025 Financial Guidance
Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its full year 2025 net product revenue guidance to $4.23 - $4.32 billion to account for higher demand for Jakafi and other hematology and oncology marketed products. The update includes raised guidance for Jakafi to $3.050 - $3.075 billion, as well as other hematology and oncology marketed products to $550 - $575 million. Incyte is reaffirming its guidance across all other categories.
| Current | Previous | |
| Jakafi net product revenues | $3,050 - $3,075 million | $3,000 - $3,050 million |
| Opzelura net product revenues | Unchanged | $630 - $670 million |
| Other oncology net product revenues (1) | $550 - $575 million | $500 - $520 million |
| GAAP Cost of product revenues | Unchanged | 8.0% - 9.0% of net product revenues |
| Non-GAAP Cost of product revenues (2) | Unchanged | 7.0% - 8.0% of net product revenues |
| GAAP Research and development expenses | Unchanged | $1,965 - $1,995 million |
| Non-GAAP Research and development expenses (3) | Unchanged | $1,815 - $1,840 million |
| GAAP Selling, general and administrative expenses | Unchanged | $1,280 - $1,310 million |
| Non-GAAP Selling, general and administrative expenses (3) | Unchanged | $1,160 - $1,185 million |
1Pemazyre in the U.S., EU and Japan Niktimvo, Monjuvi and Zynyz in the U.S. and Iclusig and Minjuvi in the EU.
2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
3Adjusted to exclude the estimated cost of stock-based compensation.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8 00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13756261.
If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13756261.
The conference call will also be webcast live and can be accessed at investor.incyte.com.
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
Incyte's unique expertise in medicinal chemistry and biology has enabled us to establish a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation Autoimmunity.
Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
About Jakafi (ruxolitinib)
Jakafi (ruxolitinib) is a JAK1 JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults steroid-refractory acute GVHD in adult and pediatric patients 12 years and older and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Jakafi is a registered trademark of Incyte.
About Opzelura (ruxolitinib) Cream
Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte's selective JAK1 JAK2 inhibitor ruxolitinib, approved by the U.S. 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.
In Europe, Opzelura (ruxolitinib) cream 15mg g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of Incyte.
About Monjuvi (tafasitamab-cxix)
Monjuvi (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
In the U.S., Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
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.
Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization 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.
XmAb is a registered trademark of Xencor, Inc.
Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.
About Pemazyre (pemigatinib)
Pemazyre (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid lymphoid neoplasms (MLNs) with FGFR1 rearrangement.