INCY Incyte Corporation

71.26
-4.8  -6%
Previous Close 76.06
Open 73.12
52 Week Low 70.97
52 Week High 101.47
Market Cap $15,736,721,269
Shares 220,835,269
Float 155,219,007
Enterprise Value $14,727,879,269
Volume 3,329,345
Av. Daily Volume 1,198,627
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Upcoming Catalysts

Drug Stage Catalyst Date
JAKAFI (Ruxolitinib)
Myelofibrosis
Approved
Approved
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OLUMIANT (baricitinib)
Atopic dermatitis
PDUFA
PDUFA
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JAKAFI (Ruxolitinib)
Vitiligo
sNDA Filing
sNDA Filing
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OLUMIANT (baricitinib)
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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Parsaclisib - (CITADEL-203)
Follicular lymphoma
NDA Filing
NDA Filing
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Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.
Phase 2
Phase 2
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OLUMIANT (baricitinib)
Alopecia Areata
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
JAKAFI (Ruxolitinib)
Steroid-refractory chronic GVHD (Graft versus host disease)
Approved
Approved
Approved September 22, 2021.
Opzelura (Ruxolitinib)
Atopic dermatitis
Approved
Approved
Approved September 21, 2021.
Capmatinib (INC280) - GEOMETRY Mono-1
Non-Small-Cell Lung Cancer
Phase 2
Phase 2
Phase 2 updated data presented at ASCO June 4, 2021. Data in abstract noted ORR of 65.6% for the treatment-naive expansion Cohort 7.
INCB54707
Vitiligo
Phase 2
Phase 2
Phase 2 trial initiated March 2021.
Retifanlimab
Squamous Cell Carcinoma of the Anal Canal (SCAC)
CRL
CRL
CRL announced July 23, 2021. Advisory Committee meeting June 24, 2021 voted 13-4 that a regulatory decision should be deferred until further data are available from clinical trial POD1UM-303.
MONJUVI (tafasitamab) with REVLIMID (lenalidomide) and RITUXAN (rituximab) - (inMIND)
Follicular lymphoma (FL) / marginal zone lymphoma (MZL)
Phase 3
Phase 3
Phase 3 initiation of dosing announced April 19, 2021.
Retifanlimab
Anal cancer
Phase 2
Phase 2
Phase 2 data noted objective response rate of 14% and disease control rate of 49% - September 18, 2020.
Itacitinib - (GRAVITAS-309)
Chronic Graft-Versus-Host Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
Retifanlimab - (POD1UM-304)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial initiation announced September 21, 2020.
TABRECTA (capmatinib)
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Parsaclisib - (CITADEL-204)
Marginal Zone Lymphoma
Phase 2
Phase 2
Phase 2 data presented at ASH December 2020. ORR 57%.
PEMAZYRE (pemigatinib)
Cholangiocarcinoma
Approved
Approved
FDA Approval announced April 17, 2020.
PEMAZYRE (pemigatinib) - (FIGHT-302)
Cholangiocarcinoma - first line
Phase 3
Phase 3
Phase 3 initiation of dosing announced June 4, 2019.
MONJUVI (tafasitamab)
Relapsed or refractory diffuse large B cell lymphoma
Approved
Approved
FDA Approval announced July 31, 2020.
OLUMIANT (baricitinib) and VEKLURY (remdesivir)
COVID-19
Approved
Approved
Emergency use authorization (EUA) issued by FDA November 19, 2020.
OLUMIANT (baricitinib)
Alopecia Areata
Phase 3
Phase 3
Phase 3 trial met primary endpoint - March 3, 2021.
OLUMIANT (baricitinib)
COVID-19
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - April 8, 2021.
OLUMIANT (baricitinib)
Rheumatoid arthritis
Approved
Approved
CRL received April 14, 2017. NDA resubmitted. Approval announced for low dose only - June 1, 2018.
JAKAFI (Ruxolitinib) - JANUS 1 and JANUS 2
Cancer - Pancreatic
Phase 3
Phase 3
Phase 3 trial discontinued due to lack of efficacy
JAKAFI (Ruxolitinib) - (RESET)
Essential thrombocythemia
Phase 3
Phase 3
Recruitment has been discontinued - February 13, 2020.
JAKAFI (Ruxolitinib)
Graft versus host disease
Approved
Approved
FDA approval announced May 24, 2019.
JAKAFI (Ruxolitinib)
Polycythemia Vera
Approved
Approved
Approved December 4, 2014.
JAKAFI (Ruxolitinib)
COVID-19 associated cytokine storm
Phase 3
Phase 3
Phase 3 top-line did not meet primary endpoint - December 14, 2020.
Epacadostat with KEYTRUDA (pembrolizumab) - (ECHO-302)
Renal cancer
Phase 3
Phase 3
Phase 3 enrollment to be discontinued.
Epacadostat with KEYTRUDA (pembrolizumab) - ECHO-301
Cancer - first-line metastatic melanoma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted April 6, 2018.
INCB001158
Biliary tract cancers
Phase 1/2
Phase 1/2
Phase 1/2 data presented at ASCO GI January 15-17, 2021.
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - January 2, 2020.

Latest News

  1. - Jakafi is approved for treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older

    - Today's approval marks the fourth FDA-approved indication for Jakafi, which received FDA-approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

    "GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet…

    - Jakafi is approved for treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older

    - Today's approval marks the fourth FDA-approved indication for Jakafi, which received FDA-approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

    "GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies," stated Steven Stein, M.D., Chief Medical Officer, Incyte. "Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today's approval of Jakafi for certain people who develop chronic GVHD."

    The FDA approval was based on the REACH3 study, a Phase 3, randomized, open-label, multicenter study of Jakafi in comparison to best available therapy (BAT) for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. The primary endpoint of overall response rate (ORR) at Week 24 (i.e., Cycle 7 Day 1) was 49.7% for Jakafi compared to 25.6% for BAT (P<0.0001)1. Furthermore, the ORR through Cycle 7 Day 1 was 70% for Jakafi compared to 57% for BAT2. The most common hematologic adverse reactions (incidence > 35%) were anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥ 20%) were infections (pathogen not specified) and viral infection. Full results from the REACH3 study were published in the New England Journal of Medicine (NEJM).

    "Nearly half of the people who develop chronic GVHD do not respond adequately to steroids – the current standard of care – making this life-threatening condition particularly challenging to treat," said Dr. Robert Zeiser, University Medical Center Freiburg, Department of Hematology, Oncology and Stem Cell Transplantation, Freiburg, Germany, the principal investigator of the REACH3 trial. "In this clinical trial, treatment with Jakafi demonstrated significantly improved outcomes across a range of efficacy measures compared to best available therapy. This approval represents a significant advancement in the treatment of appropriate patients with chronic GVHD – for both the patients who face a poor prognosis and the healthcare providers who struggle to effectively treat them."

    GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient's organs. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs more than 100 days after transplant3. Both forms are associated with significant morbidity and mortality and can affect multiple organ systems.

    "In the U.S., there are over 14,000 people living with chronic GVHD, many of whom face significant complications that may impair daily activities and linger for years," said Susan Stewart, Executive Director, BMT InfoNet. "The approval of Jakafi is an exciting development for the GVHD community and an important step forward in the treatment of a disease with few options."

    Jakafi's supplemental New Drug Application (sNDA) in chronic GHVD was reviewed under the FDA's Priority Review program as well as the Project Orbis program, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Participating countries for this application include Canada, Australia, Switzerland, Brazil and the United Kingdom.

    Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Jakafi have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering patient support, including financial assistance and ongoing education and resources to eligible patients. More information about IncyteCARES is available by visiting www.incytecares.com or calling 1-855-452-5234.

    About REACH3

    REACH3 (NCT03112603), a randomized, open-label, multicenter Phase 3 study co-sponsored by Novartis and Incyte, evaluated the safety and efficacy of ruxolitinib compared with best available therapy (BAT) in patients with steroid-refractory chronic GVHD.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.

    About Jakafi® (ruxolitinib)

    Jakafi is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

    Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults, and for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older2.

    Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi® (ruxolitinib) outside the U.S. Jakafi is a registered trademark of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the U.S.

    Important Safety Information

    Jakafi can cause serious side effects, including:

    Low blood counts: Jakafi® (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

    Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

    Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with Jakafi. Your healthcare provider will regularly check your skin during your treatment with Jakafi. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with Jakafi.

    Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with Jakafi. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking Jakafi, and as needed.

    Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis: Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Jakafi, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of your body, slurred speech

    Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, (PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Jakafi, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing

    Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

    The most common side effects of Jakafi include: for certain types of MF and PV – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling; and for chronic GVHD – low red blood cell or platelet counts and infections including viral infections.

    These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

    Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had low white or red blood cell counts, have or had tuberculosis (TB) or have been in close contact with someone who has TB, had shingles (herpes zoster), have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had cancer, are a current or past smoker, had a blood clot, heart attack, other heart problems or stroke, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.

    Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.

    Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    You may also report side effects to Incyte Medical Information at 1-855-463-3463.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when Jakafi might provide a successful treatment option for patients with steroid-refractory chronic GVHD, the Company's ongoing clinical development program for ruxolitinib and the REACH clinical trial program, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials supply chain and other third-party providers and development and discovery operations; determinations made by the FDA or other regulatory authorities; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.


    1 Zeiser R, M.D., et al. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. New England Journal of Medicine; July 2021.

    2 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug Administration; September 2021.

    3 Ferrara JL., et al. Graft-versus-host disease. Lancet. 2009;373(9674):1550-1561.

    View Full Article Hide Full Article
  2. - Opzelura is the first and only topical Janus kinase (JAK) inhibitor approved in the United States

    - In Phase 3 studies, Opzelura significantly reduced the skin inflammation and itch associated with AD

    - Investor conference call and webcast scheduled for September 22, 2021, at 8:00 a.m. ET

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation…

    - Opzelura is the first and only topical Janus kinase (JAK) inhibitor approved in the United States

    - In Phase 3 studies, Opzelura significantly reduced the skin inflammation and itch associated with AD

    - Investor conference call and webcast scheduled for September 22, 2021, at 8:00 a.m. ET

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of AD such as itch, inflammation and skin barrier dysfunction1.

    "Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease," said Jonathan Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences. "As a clinician, I am excited to have a non-steroidal topical cream like Opzelura."

    "The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation," said Hervé Hoppenot, Chief Executive Officer, Incyte. "At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases."

    The FDA approval was based on data from the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) clinical trial program, consisting of two randomized, double-blind, vehicle-controlled Phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to vehicle (non-medicated cream):

    • Significantly more patients treated with Opzelura achieved Investigator's Global Assessment (IGA) Treatment Success (IGA-TS, primary endpoint) at Week 8 (defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a 2-point improvement from baseline): 53.8% in TRuE-AD1 and 51.3% in TRuE-AD2, compared to vehicle (15.1% in TRuE-AD1, 7.6% in TRuE-AD2; P<0.0001).
    • Significantly more patients treated with Opzelura experienced a clinically meaningful reduction in itch from baseline at Week 8, as measured by a ≥4-point reduction in the itch Numerical Rating Scale (itch NRS4): 52.2% in TRuE-AD1 and 50.7% in TRuE-AD2, compared to vehicle (15.4% in TRuE-AD1, 16.3% in TRuE-AD2; P<0.0001), among patients with an NRS score of at least 4 at baseline.

    In clinical trials, the most common (≥1%) treatment-emergent adverse reactions in patients treated with Opzelura were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis and rhinorrhea2. See Important Safety Information below, including Boxed Warnings for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis, seen with JAK inhibitors for inflammatory conditions.

    "It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients," said Julie Block, President & CEO, National Eczema Association. "The chronic itch is difficult to cope with and related sleep issues can be exhausting. Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD. The approval of Opzelura is exciting news, and we welcome a new treatment option for our community."

    AD is a chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S. and is characterized by inflammation and itch3. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections4.

    Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Opzelura have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a program offering patient support, including financial assistance and ongoing education and resources to eligible patients. For more information about IncyteCARES, please visit www.incytecares.com or call 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.

    Conference Call Information

    Incyte will host an analyst and investor conference call and webcast on September 22, 2021, at 8:00 a.m. ET. The live and archived webcast will be available via investor.incyte.com.

    To access the conference call, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers (conference identification number 13723195).

    If you are unable to participate, a replay 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 +1-201-612-7415 (conference identification number 13723195).

    About TRuE-AD

    The TRuE-AD clinical trial program evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD) consists of two randomized, double-blind, vehicle-controlled Phase 3 studies: TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651). Both studies enrolled more than 600 patients (age ≥12 years) who had been previously diagnosed with AD for at least two years and who were candidates for topical therapy.

    Key findings from the TRuE-AD1 and TRuE-AD2 studies were presented at the European Academy of Dermatology and Venereology (EADV) Congress, Revolutionizing Atopic Dermatitis Virtual Symposium and previously announced by Incyte.

    About Opzelura (ruxolitinib) Cream

    Opzelura, a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

    Additionally, ruxolitinib cream is in Phase 3 development for the treatment of adolescents and adults with vitiligo in the TRuE-V clinical program. Results from this Phase 3 program were recently announced.

    Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

    Opzelura is a trademark of Incyte.

    IMPORTANT SAFETY INFORMATION

    OPZELURA cream is for use on the skin only. Do not use OPZELURA cream in your eyes, mouth or vagina.

    OPZELURA may cause serious side effects, including:

    Serious Infections: OPZELURA cream contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.

    OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.

    Increased risk of death from all causes, including sudden cardiac death, has happened in people taking JAK inhibitors by mouth.

    Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Some people have had lymphoma and other cancers while taking JAK inhibitors by mouth, especially if they are a current or past smoker. Some people have had skin cancers while taking OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA.

    There is an increased risk of major cardiovascular events such as heart attack, stroke or cardiac death in people with cardiovascular risk factors and who are current or past smokers while using JAK inhibitors to treat inflammatory conditions.

    Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening.

    Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.

    Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.

    Before starting OPZELURA, tell your healthcare provider if you:

    • have an infection, are being treated for one, or have an infection that keeps coming back
    • have diabetes, chronic lung disease, HIV, or a weak immune system
    • have TB or have been in close contact with someone with TB
    • have had shingles (herpes zoster) or hepatitis B or C
    • live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
    • think you have an infection or have symptoms of an infection such as:
    • fever, sweating, or chills
    • muscle aches
    • cough or shortness of breath
    • blood in your phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinating more often than usual
    • feeling very tired
    • have ever had any type of cancer, or are a current or past smoker.
    • have had blood clots in the veins of your legs or lungs in the past.
    • have high cholesterol or triglycerides
    • have or have had low white or red blood cell counts
    • are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.
    • are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.

    After starting OPZELURA:

    • Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
    • Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
      • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
      • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
      • pain or discomfort in your arms, back, neck, jaw, or stomach
      • shortness of breath with or without chest discomfort
      • breaking out in a cold sweat
      • nausea or vomiting
      • feeling lightheaded
      • weakness in one part or on one side of your body
      • slurred speech
    • Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
    • Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as:  unusual bleeding, bruising, tiredness, shortness of breath or fever.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    The most common side effects of OPZELURA include: pain or swelling in your nose or throat (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell counts (eosinophil), hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsilitis), and runny nose (rhinorrhea).

    These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

    About Incyte Dermatology

    Incyte's science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company's research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

    Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when Opzelura might provide a successful treatment option for patients with atopic dermatitis, the Company's ongoing clinical development program for ruxolitinib cream and its dermatology program generally, contain predictions, estimates, and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials, supply chain and other third-party providers and development and discovery operations; determinations made by the FDA or other regulatory authorities; the efficacy or safety of the Company's products; the acceptance of the Company's products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

    ________________________________

    1 Bao L, et al. JAK-STAT. 2013;2(3):e24137. doi:10.4161/jkst.24137.

    2 Ruxolitinib cream Prescribing Information. Wilmington, DE. Incyte Corporation.

    3 U.S. Census Bureau (2020). 2020 Decennial Census. Retrieved from https://data.census.gov/cedsci/table?q=Populations%20and%20People&tid=DECENNIALPL2020.P1 [data.census.gov].

    4 Boguniewicz M, et al. Ann Allergy Asthma Immunol. 2018;120(1):10-22.

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  3. MONTREAL, Sept. 17, 2021 /CNW/ - Incyte (NASDAQ:INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, 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.

    "For appropriate patients with cholangiocarcinoma, the approval of Pemazyre in Canada offers patients hope with a new potential treatment option after their cancer has returned, following the failure of first-line treatment," said Durhane Wong-Rieger, Ph.D., President and CEO, Canadian Organization for Rare Disorders.

    "Cholangiocarcinoma is a rare cancer of the bile duct with limited treatment options. As a result, patients face a poor prognosis," said Dr. Vincent Tam, MD, Medical Oncologist, Tom Baker Cancer Centre. "With the approval of Pemazyre, we now have a targeted treatment option for those patients with progressive disease after first-line chemotherapy."

    The conditional approval is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.  Study results demonstrated that in patients harbouring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 35.5 percent (primary endpoint) and median duration of response (DOR) of 9.1 months (secondary endpoint) with a median follow-up of 15.4 months.  Adverse events observed included serous retinal detachment (SRD) and hyperphosphatemia.  The most common adverse reactions (incidence ≥15%) are hyperphosphatemia, alopecia, diarrhea, fatigue, nail toxicity, dysgeusia, nausea, constipation, stomatitis, dry mouth, decreased appetite, vomiting, dry eye, arthralgia, abdominal pain, hypophosphatemia, dry skin, edema peripheral, weight decreased, headache, urinary tract infection, dehydration, hypercalcemia, and palmar-plantar erythrodysaesthesia syndrome.

    "We are pleased that Health Canada has granted conditional marketing authorization for Pemazyre and Incyte welcomes the opportunity to serve the cholangiocarcinoma community with this much-needed treatment option," said Josée Brisebois, Ph.D.., Head of Medical Affairs, Incyte Biosciences Canada. "Incyte will strive to secure rapid access across Canada to this innovative targeted therapy to patients suffering from this difficult disease."

    Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver, and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver.  Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.1,2 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in North America and Europe.1   FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16% of patients.3,4,5,6 FGFRs play an important role in tumour cell proliferation and survival, migration, and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations, and gene amplifications in FGFRs are closely correlated with the development of various cancers.

    About FIGHT-202

    The FIGHT-202 is a multi-center, open-label, single-arm, Phase 2 study (NCT02924376) that evaluated the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement.

    Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genomic alterations) or Cohort C (no FGF/FGFR genomic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

    The primary endpoint of FIGHT-202 was overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; and duration of response (DOR).

    For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.

    About FIGHT

    The FIGHT (Fibroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating the safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumour malignancies harbouring activating FGFR mutations or translocations, irrespective of tumour type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy as first-line treatment for metastatic or unresectable bladder cancer harbouring FGFR3 mutations or rearrangements who are not eligible to receive cisplatin.  FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

    About Pemazyre® (pemigatinib)

    Pemazyre is a kinase inhibitor indicated 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.6

    In the United States, Pemazyre is approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an 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).

    In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

    In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

    Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3, which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

    Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

    Pemazyre is a trademark of Incyte.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the FIGHT clinical trial program and whether Pemazyre might provide a successful treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, contain predictions, estimates and other forward-looking statements. 

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

    _______________________________

    1 

    Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261‒280.

    2 

    Uhlig J, et al. Ann Surg Oncol. 2019;26:1993–2000.

    3 

    Graham RP, et al. Hum Pathol. 2014;45:1630‒1638.

    4 

    Farshidfar F, et al. Cell Rep. 2017;18(11):2780–2794.

    5 

    Ross JS et al. The Oncologist. 2014;19:235–242.

    6 

    Pemazyre® (pemigatinib) [Product Monograph]. Wilmington, DE: Incyte; September 2021

    SOURCE Incyte Biosciences Canada

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2021/17/c9502.html

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  4. Nimble Therapeutics, a biotechnology company revolutionizing the discovery and development of peptide therapeutics, today announced their strategic research collaboration with Incyte (NASDAQ:INCY) has been expanded to include discovery of additional novel peptide therapies.

    "Nimble looks forward to building upon on the already strong collaboration between the Nimble and Incyte scientific teams. The expansion of the collaboration serves as yet another important validation of Nimble's powerful capabilities and approach towards engineering the next generation of peptide therapeutics," said Jigar Patel, CEO and Founder of Nimble Therapeutics.

    Under the terms of the agreement, Nimble will receive an upfront payment and reimbursement of certain…

    Nimble Therapeutics, a biotechnology company revolutionizing the discovery and development of peptide therapeutics, today announced their strategic research collaboration with Incyte (NASDAQ:INCY) has been expanded to include discovery of additional novel peptide therapies.

    "Nimble looks forward to building upon on the already strong collaboration between the Nimble and Incyte scientific teams. The expansion of the collaboration serves as yet another important validation of Nimble's powerful capabilities and approach towards engineering the next generation of peptide therapeutics," said Jigar Patel, CEO and Founder of Nimble Therapeutics.

    Under the terms of the agreement, Nimble will receive an upfront payment and reimbursement of certain research program costs and may become eligible for downstream milestone payments and royalties. Incyte has exclusive rights to develop and commercialize any peptides discovered under the collaboration and has an option to further expand the collaboration to include additional targets.

    About Nimble Therapeutics

    Nimble Therapeutics is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful analytics to efficiently and intelligently discover and develop next generation peptide therapeutics.

    Connect with us on LinkedIn at www.linkedin.com/company/nimble-therapeutics or visit our website at www.nimbletherapeutics.com to learn more.

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    • Data from the Phase 3 TRuE-V program of ruxolitinib cream in vitiligo to be presented for the first time in a late-breaking oral presentation

    Incyte (NASDAQ:INCY) today announced that multiple abstracts highlighting data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with vitiligo and atopic dermatitis (AD) will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, held virtually from September 29-October 2, 2021.

    The 24-week data from the Phase 3 TRuE-V program evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo will be presented as a late-breaking oral presentation. Incyte previously

    • Data from the Phase 3 TRuE-V program of ruxolitinib cream in vitiligo to be presented for the first time in a late-breaking oral presentation

    Incyte (NASDAQ:INCY) today announced that multiple abstracts highlighting data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with vitiligo and atopic dermatitis (AD) will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, held virtually from September 29-October 2, 2021.

    The 24-week data from the Phase 3 TRuE-V program evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo will be presented as a late-breaking oral presentation. Incyte previously announced that both the TRuE-V1 and TRuE-V2 studies met the primary and key secondary endpoints.

    "We look forward to sharing data demonstrating the potential of ruxolitinib cream as an effective treatment option for patients living with vitiligo with the dermatology community at this year's EADV virtual congress," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "These data from the Phase 3 TRuE-V program underscore our commitment to bringing new therapies to patients with challenging skin diseases."

    Key abstracts include:

    Late-Breaking Oral Presentation

    Vitiligo

    Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: 24-Week Results From 2 Randomized, Double-Blind Phase 3 Studies (Abstract #D3T01.2A. Session: Late Breaking News. Saturday, October 2, 5:15-6:15 a.m. ET)

    Oral Presentation

    Atopic Dermatitis

    Efficacy and Safety of Ruxolitinib Cream among Patients Aged ≥65 Years with Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #FC01.01. Session: Atopic dermatitis/Eczema. Thursday, September 30, 4:00-4:10 a.m. ET)

    Poster Presentations

    Atopic Dermatitis

    Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Baseline Clinical Characteristics (encore) (Abstract #P0187. Session: Atopic dermatitis/Eczema)

    Efficacy of Ruxolitinib Cream among Patients with Atopic Dermatitis Based on Previous Medication History (encore) (Abstract #P0192. Session: Atopic dermatitis/Eczema)

    Effects of Ruxolitinib Cream in Patients with Atopic Dermatitis with Baseline Body Surface Area ≥10% and Eczema Area and Severity Index Score ≥16 (encore) (Abstract #P0190. Session: Atopic dermatitis/Eczema)

    Patient-Reported Outcomes of Ruxolitinib Cream for the Treatment of Atopic Dermatitis (encore) (Abstract #P0188. Session: Atopic dermatitis/Eczema)

    More information regarding the virtual conference is available on the EADV website: https://www.eadvcongress2021.org/. Following the conference, all e-Posters will be made available online on http://www.eadv.org for EADV members.

    About Ruxolitinib Cream

    Ruxolitinib cream is a proprietary formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

    About Incyte Dermatology

    Incyte's science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company's research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

    Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding Incyte's TRuE-V clinical program, whether and when ruxolitinib cream might be approved to treat patients with vitiligo or atopic dermatitis (AD), the potential for success of such treatment, and Incyte's Dermatology program generally, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the U.S. FDA and other regulatory authorities outside of the United States; the efficacy or safety of the Company's products; the acceptance of the Company's products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

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