INCY Incyte Corporation

82.27
-0.35  -0%
Previous Close 82.62
Open 82.47
52 Week Low 75.52
52 Week High 110.365
Market Cap $18,093,104,453
Shares 219,923,477
Float 154,307,215
Enterprise Value $16,253,814,669
Volume 1,184,307
Av. Daily Volume 1,221,421
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Upcoming Catalysts

Drug Stage Catalyst Date
Jakafi
Myelofibrosis
Approved
Approved
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Ruxolitinib
Atopic dermatitis
PDUFA priority review
PDUFA priority review
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Ruxolitinib
Steroid-refractory chronic GVHD (Graft versus host disease)
PDUFA priority review
PDUFA priority review
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Baricitinib
Atopic dermatitis
PDUFA
PDUFA
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Retifanlimab
Squamous Cell Carcinoma of the Anal Canal (SCAC)
PDUFA priority review
PDUFA priority review
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Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.
Phase 2
Phase 2
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Baricitinib
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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INCB86550
Solid Tumors
Phase 1
Phase 1
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Parsaclisib INCB50465 (CITADEL-203)
Follicular lymphoma
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
Ruxolitinib - TRuE-V
Vitiligo
Phase 3
Phase 3
Phase 3 trial met primary endpoint - May 17, 2021.
Ruxolitinib (RESET)
Essential thrombocythemia
Phase 3
Phase 3
Recruitment has been discontinued - February 13, 2020.
Tafasitamab in combination with lenalidomide and rituximab (inMIND)
Follicular lymphoma (FL) / marginal zone lymphoma (MZL)
Phase 3
Phase 3
Phase 3 initiation of dosing announced April 19, 2021.
INCB54707
Vitiligo
Phase 2
Phase 2
Phase 2 trial initiated March 2021.
Baricitinib (BRAVE-AA1)
Alopecia Areata
Phase 3
Phase 3
Phase 3 trial met primary endpoint - April 19, 2021.
Baricitinib
COVID-19
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - April 8, 2021.
Ruxolitinib (RUXCOVID-DEVENT)
COVID-19
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 18, 2021.
Baricitinib
Alopecia Areata
Phase 3
Phase 3
Phase 3 trial met primary endpoint - March 3, 2021.
Parsaclisib (CITADEL-204)
Marginal Zone Lymphoma
Phase 2
Phase 2
Phase 2 data presented at ASH December 2020. ORR 57%.
INCB001158
Biliary tract cancers
Phase 1/2
Phase 1/2
Phase 1/2 data presented at ASCO GI January 15-17, 2021.
Ruxolitinib (Jakafi)
COVID-19 associated cytokine storm
Phase 3
Phase 3
Phase 3 top-line did not meet primary endpoint - December 14, 2020.
Baricitinib and remdesivir
COVID-19
Approved
Approved
Emergency use authorization (EUA) issued by FDA November 19, 2020.
Itacitinib - GRAVITAS-309
Chronic Graft-Versus-Host Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
Retifanlimab (MGA012/INCMGA00012) - (POD1UM-304)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial initiation announced September 21, 2020.
Retifanlimab INCMGA0012
Anal cancer
Phase 2
Phase 2
Phase 2 data noted objective response rate of 14% and disease control rate of 49% - September 18, 2020.
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 3
Phase 3
Phase 3 data met primary endpoint - October 16, 2019.
Tafasitamab (MOR208/XmAb5574)
Relapsed or refractory diffuse large B cell lymphoma
Approved
Approved
FDA Approval announced July 31, 2020.
Capmatinib
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Pemigatinib
Cholangiocarcinoma
Approved
Approved
FDA Approval announced April 17, 2020.
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - January 2, 2020.
Pemigatinib (FIGHT-302)
Cholangiocarcinoma - first line
Phase 3
Phase 3
Phase 3 initiation of dosing announced June 4, 2019.
Epacadostat with pembrolizumab (ECHO-302)
Renal cancer
Phase 3
Phase 3
Phase 3 enrollment to be discontinued.
Ruxolitinib
Graft versus host disease
Approved
Approved
FDA approval announced May 24, 2019.
INCB50465 (CITADEL-202)
Diffuse large B cell lymphoma
Phase 2
Phase 2
Phase 2 trial to be discontinued - noted June 21, 2018.
Baricitinib
Rheumatoid arthritis
Approved
Approved
CRL received April 14, 2017. NDA resubmitted. Approval announced for low dose only - June 1, 2018.
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted April 6, 2018.
Ruxolitinib - JANUS 1 and JANUS 2
Cancer - Pancreatic
Phase 3
Phase 3
Phase 3 trial discontinued due to lack of efficacy
Ruxolitinib
Colorectal cancer
Phase 2
Phase 2
Phase 2 trial stopped January 2016 due to lack of efficacy
Jakafi (ruxolitinib) (RELIEF)
Disease-related symptoms in patients with Polycythemia Vera
Phase 3
Phase 3
Endpoint not met, mid-2014
Jakafi (ruxolitinib) (RESPONSE)
Polycythemia Vera
Approved
Approved
Approved December 4, 2014.

Latest News

  1. -Primary and key secondary endpoints met in both TRuE-V1 and TRuE-V2 studies

    -Data will support planned U.S. and EU regulatory submissions for ruxolitinib cream in vitiligo in the second half of 2021

    Incyte (NASDAQ:INCY) today announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age ≥12 years) with vitiligo.

    -Primary and key secondary endpoints met in both TRuE-V1 and TRuE-V2 studies

    -Data will support planned U.S. and EU regulatory submissions for ruxolitinib cream in vitiligo in the second half of 2021

    Incyte (NASDAQ:INCY) today announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age ≥12 years) with vitiligo.

    Both the TRuE-V1 and TRuE-V2 studies met the primary endpoint (p<0.0001 for both studies), demonstrating that significantly more patients treated with ruxolitinib cream 1.5% twice daily (BID) achieved a ≥75% improvement from baseline in the facial vitiligo area scoring index (F-VASI75) compared to patients treated with a vehicle control at Week 24.

    The studies also met key secondary endpoints including patient reported outcomes. The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data, and no new safety signals were observed. The long-term efficacy and safety portions of both studies will continue as planned. Additionally, data from both studies will be submitted for publication and presentation at an upcoming scientific meeting in the second half of 2021.

    "These positive results – the first Phase 3 data to demonstrate significant improvements in facial and total body repigmentation – confirm the potential of ruxolitinib cream to be a meaningful treatment option for individuals living with and seeking treatment for their vitiligo," said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "We look forward to working with regulators to bring this much needed treatment option to patients. If approved, ruxolitinib cream would be the first and only medical treatment for repigmentation in vitiligo."

    Based on these findings, Incyte plans to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age ≥12 years) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the second half of 2021. The FDA is currently reviewing a New Drug Application (NDA) for ruxolitinib cream for the treatment of adolescents and adults (age ≥12 years) with atopic dermatitis, a type of eczema.

    "Vitiligo is a chronic immune-mediated skin condition that can significantly impact quality of life for those living with, and suffering from, this disease," said David Rosmarin, M.D., Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center. "As a clinician, I am extremely encouraged by the initial findings from the TRuE-V program and the potential to have ruxolitinib cream as a future topical treatment option for vitiligo patients, who currently have limited therapies available that effectively and safely address repigmentation."

    About Vitiligo

    Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. It affects approximately 0.5% to 2.0% of the population globally1 and there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA)-approved drug therapies for the treatment of vitiligo. It can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 202.

    About TRuE-V

    The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.

    The studies each enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5% of the body surface area (BSA) on the face, ≥0.5 facial vitiligo area severity index [F-VASI] score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo Area Scoring Index [T-VASI] score and total BSA involvement (facial and nonfacial) of up to 10%. Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period. Patients who successfully completed baseline and Week 24 assessments, including those that received vehicle control during the double-blind phase, were offered treatment extension with 1.5% ruxolitinib cream BID for an additional 28 weeks.

    The primary endpoint of both studies in the TRuE-V program is the proportion of patients achieving F-VASI75, defined as at least a 75% improvement from baseline in the F-VASI score at Week 24. Key secondary endpoints include: the percentage change from baseline in facial BSA (F-BSA) at Week 24, the proportion of patients achieving F-VASI50 (at least 50% improvement from baseline in the F-VASI), F-VASI90 (at least 90% improvement from baseline in the F-VASI) and T-VASI50 (at least 50% improvement from baseline in the T-VASI) at Week 24, the proportion of patients achieving F-VASI75, F-VASI90, T-VASI50 and T-VASI75 (at least 75% improvement from baseline in the T-VASI) at Week 52 and the proportion of patients achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Week 24. The studies also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

    For more information on the TRuE-V studies, please visit https://clinicaltrials.gov/ct2/show/NCT04052425 and https://clinicaltrials.gov/ct2/show/NCT04057573.

    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 atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with 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 the Company's ongoing clinical development program for ruxolitinib cream in patients with vitiligo, the enrollment, design, timing and results of the TRuE-V clinical trial program, and whether ruxolitinib cream will become an approved treatment option for patients with vitiligo, 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 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; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report on Form 10-Q for the quarter ending March 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

    1 Kruger C. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212.

    2 Rodrigues M. New Discoveries in the pathogenesis and classification of vitiligo. J Am Acad Dermatol. 2017; 77:1-13.

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  2. Incyte (NASDAQ:INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) 2021 Virtual Congress, held virtually from June 9-17, 2021.

    "We are pleased that data highlighting the strength of Incyte's oncology portfolio and partner-sponsored programs will be presented at this year's EHA Virtual Congress," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia; an oral presentation on real-world data for ruxolitinib, our…

    Incyte (NASDAQ:INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) 2021 Virtual Congress, held virtually from June 9-17, 2021.

    "We are pleased that data highlighting the strength of Incyte's oncology portfolio and partner-sponsored programs will be presented at this year's EHA Virtual Congress," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia; an oral presentation on real-world data for ruxolitinib, our JAK1/JAK2 inhibitor; and an ePoster from our Phase 2 combination study of ruxolitinib and parsaclisib in patients with myelofibrosis – reinforce our commitment to finding solutions for patients with significant unmet medical needs."

    Key abstracts accepted by EHA include:

    Oral Presentations

    Ponatinib

    OPTIC Primary Analysis: A Dose-Optimization Study of 3 Starting Doses of Ponatinib (PON)1 (Abstract #S153. Session: Response, Resistance and Treatment-Free Remission in CML.)

    Ruxolitinib

    Efficacy and Safety of Ruxolitinib in Patients with Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in the Phase 3 REACH2 Study2 (Abstract #S236. Session: Stem cell transplantation – GvHD.)

    Impact of Ruxolitinib on Survival of Patients with Myelofibrosis in Real World – Update of ERNEST (European Registry for Myeloproliferative Neoplasms) Study2 (Abstract #S158. Session: Population based studies in myeloid disorders.)

    ePosters

    Parsaclisib

    Efficacy and Safety Results from an Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP685. Session: Enzymopathies, Membranopathies and Other Anemias.)

    Pharmacologic Inhibition of PI3kδ Reduces Autoantibody Formation and is Efficacious in a Preclinical Model of Autoimmune Hemolytic Anemia (Abstract #EP693. Session: Enzymopathies, Membranopathies and Other Anemias.)

    FACIT-Fatigue Subscale Outcomes from an Ongoing Phase 2, Open-Label Study of the Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor Parsaclisib in Patients with Autoimmune Hemolytic Anemia (AIHA) (Abstract #EP706. Session: Enzymopathies, Membranopathies and Other Anemias.)

    Ponatinib

    French Real-Life Observational Study "TOPASE" Evaluating Safety and Efficacy of Ponatinib Confirms Induction of Deep Molecular Responses in 110 Resistant or Intolerant CML Patients (Abstract #EP679. Session: Chronic Myeloid Leukemia – Clinical.)

    Ruxolitinib

    An Epidemiological Study of the Cardiovascular Health and Thrombotic Risk Profiles of Patients with Myeloproliferative Neoplasms in Primary Care Across the United Kingdom2 (Abstract #EP1090. Session: Myeloproliferative Neoplasms – Clinical.)

    Impact of Bone Marrow Fibrosis Grade on Response and Outcome in Patients with Primary Myelofibrosis Treated with Ruxolitinib: A Post-Hoc Analysis of the JUMP Study2 (Abstract #EP1092. Session: Myeloproliferative Neoplasms – Clinical.)

    Healthcare Resource Utilization in Patients with Myeloproliferative Neoplasms: A Nationwide Matched Cohort Study2 (Abstract #EP1107. Session: Myeloproliferative Neoplasms – Clinical.)

    Ruxolitinib-Parsaclisib Combination Studies

    Add-On Parsaclisib (a PI3kδ inhibitor) in Patients with Myelofibrosis and Suboptimal Response to Ruxolitinib: Interim Analysis from a Phase 2 Study (Abstract #EP1075. Session: Myeloproliferative Neoplasms – Clinical.)

    Tafasitamab

    Estimation of Long-Term Survival with Tafasitamab + Lenalidomide in Relapsed/Refractory Diffuse Large B-Cell Lymphoma3 (Abstract #EP553. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)

    First-MIND: A Phase 1b, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed DLBCL3 (Abstract #EP496. Session: Aggressive Non-Hodgkin Lymphoma – Clinical.)

    Lenalidomide-Induced Effects on Cell Surface Expression of CD19 and CD20 in DLBCL Cell Lines and Functional Impact on Antibody-Mediated Cytotoxicity3 (Abstract #EP879 . Session: Lymphoma Biology & Translational Research.)

    In addition to the presentations noted above, more than 10 publications highlighting data from Incyte's portfolio will be made available by EHA as publications. Notably, these publications include bioequivalence and bioavailability data for ruxolitinib's once-daily extended release (XR) formulation – Bioequivalence of 50 mg Once-Daily Ruxolitinib Extended Release (XR) Tablets Compared to 25 mg Twice-Daily Ruxolitinib Immediate Release (IR) Tablets (Abstract #PB1706) and Relative Bioavailability and Dose Linearity of Five Strengths of Ruxolitinib Extended Release (XR) Tablets (Abstract #PB1717).

    Full listings for oral presentations and ePoster sessions are available on the EHA website: https://library.ehaweb.org. Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at EHA will be available on demand for registered attendees beginning Friday, June 11, 2021, through Sunday, August 15, 2021.

    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 the presentation of data from the Company's or partner company's ongoing clinical development pipeline, and whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, its presentation plans for the upcoming EHA meeting and its goal of improving the lives of patients, 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 and other regulatory authorities outside of the United States; the Company's dependence on its relationships with its collaboration partners; 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 March 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

    ________________

    1 Takeda-sponsored abstract.

    2 Novartis-sponsored abstract.

    3 MorphoSys-sponsored abstract.

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  3. PLANEGG/MUNICH, GERMANY and WILMINGTON, DE / ACCESSWIRE / May 11, 2021 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.

    "While more than half of DLBCL patients can be cured with an aggressive chemotherapy regimen, current…

    PLANEGG/MUNICH, GERMANY and WILMINGTON, DE / ACCESSWIRE / May 11, 2021 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.

    "While more than half of DLBCL patients can be cured with an aggressive chemotherapy regimen, current outcomes for high-risk patients are poor," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. "We believe we may be able to make a difference for those DLBCL patients by adding the combination of tafasitamab and lenalidomide to R-CHOP, a current standard of care."

    Each year, approximately 30,000 patients are diagnosed with DLBCL in the U.S. alone1,2. R-CHOP is a current standard of care for patients with previously untreated DLBCL, but about 40% of patients do not respond to R-CHOP or relapse - particularly those with high-intermediate and high-risk disease3.

    "Despite improvements in treatment for patients with DLBCL, there continues to be a significant medical need for additional therapies with improved outcomes," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "We are pleased to have initiated the frontMIND study as we seek meaningful, new options for newly diagnosed, high-risk patients with DLBCL."

    In December 2020, encouraging preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of R-CHOP plus either tafasitamab or tafasitamab plus lenalidomide for patients with newly diagnosed DLBCL, were presented at the American Society of Hematology (ASH) Annual Meeting. The data showed a preliminary response rate of 91.1% across both arms in a patient population that overall had a poor prognosis, and that the combination of tafasitamab, lenalidomide and R-CHOP has an acceptable tolerability profile. These results informed and supported further investigation of the tafasitamab combination in the frontMIND study.

    In July 2020, the FDA approved Monjuvi® (tafasitamab-cxix) 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 autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)4.

    The FDA decision represented the first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.

    About Diffuse Large B-cell Lymphoma (DLBCL)

    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide5, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter, leading to a high medical need for new, effective therapies, especially for patients who are not eligible for an autologous stem cell transplant in this setting6.

    About frontMIND

    The frontMIND (NCT04824092) trial is a randomized, double-blind, placebo-controlled, global Phase 3 clinical study in previously untreated high-intermediate and high-risk DLBCL patients that is conducted in partnership with the German Lymphoma Association (GLA), the Italian Lymphoma study group and the US Oncology Network.

    The study aims to enroll approximately 880 DLBCL patients to receive either tafasitamab plus lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-CHOP alone. The primary endpoint is investigator-assessed progression-free survival, according to Lugano 2014 criteria, and key secondary endpoints include event-free survival by investigator, overall survival, metabolic complete response rate by a Blinded Independent Review Committee, and overall response rate.

    For more information about the frontMIND trial, visit https://clinicaltrials.gov/ct2/show/study/NCT04824092?term=NCT04824092&draw=2&rank=1.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration 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). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi® is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi® is a registered trademark of MorphoSys AG.

    XmAb® is a registered trademark of Xencor, Inc.

    Important Safety Information

    What are the possible side effects of MONJUVI?

    MONJUVI may cause serious side effects, including:

    • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
    • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
    • Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

    The most common side effects of MONJUVI include:

    • Feeling tired or weak
    • Diarrhea
    • Cough
    • Fever
    • Swelling of lower legs or hands
    • Respiratory tract infection
    • Decreased appetite

    These are not all the possible side effects of MONJUVI.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

    • Have an active infection or have had one recently.
    • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
      • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
      • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
    • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

    You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

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

    Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies which are developed by partners in different areas of unmet medical need. In 2017, Tremfya® (guselkumab) - developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis - became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech, Inc.

    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.

    MorphoSys Forward-looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    Incyte Forward-looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's ongoing clinical development program for tafasitamab, its frontMIND program, its diffuse large B-cell lymphoma (DLBCL) program generally and whether the combination of tafasitamab and lenalidomide with R-CHOP as first-line treatment will be approved for use in the U.S. or elsewhere for newly diagnosed patients with DLBCL, or any other indication, 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 U.S. FDA and 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; greater than expected expenses; expenses relating to litigation or strategic activities; 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 March 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

    Contacts:

    MorphoSys

    Media Contacts:
    Thomas Biegi
    Vice President
    Tel.: +49 (0)89 / 89927 26079

    Investor Contacts:
    Dr. Julia Neugebauer
    Senior Director
    Tel: +49 (0)89 / 899 27 179

    Jeanette Bressi
    Director, U.S. Communications
    Tel: +1 617-404-7816

    Myles Clouston
    Senior Director
    Tel: +1-857-772-0240

    Incyte

    Media Contacts:
    Catalina Loveman
    Executive Director, Public Affairs
    Tel: +1 302 498 6171

    Investor Contact:
    Christine Chiou
    Senior Director, Investor Relations
    Tel: +1 302 274 4773

    Jenifer Antonacci
    Senior Director, Public Affairs
    Tel: +1 302 498 7036


    References

    1Decision Resources Group. Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, Landscape & Forecast. 2020.

    2Teras, L, et al. 2016 US Lymphoid Malignancy Statistics by World Health Organization Subtypes. CA: A Cancer Journal for Clinicians 2016;66:443-459.

    3Sehn LH and Salles G. Diffuse Large B-Cell Lymphoma Review. NEJM 2021. https://www.nejm.org/doi/full/10.1056/NEJMra2027612.

    4Monjuvi® (tafasitamab-cxix) [Package Insert]. Boston, MA: MorphoSys; 2020.

    5Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.

    6Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.

    SOURCE: MorphoSys AG



    View source version on accesswire.com:
    https://www.accesswire.com/646526/MorphoSys-and-Incyte-Announce-First-Patient-Dosed-in-Phase-3-frontMIND-Study-Evaluating-Tafasitamab-Combination-as-a-First-line-Treatment-for-Diffuse-Large-B-Cell-Lymphoma

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  4. Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE:MOR, NASDAQ:MOR) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511006085/en/

    "While more than half of DLBCL patients…

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE:MOR, NASDAQ:MOR) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511006085/en/

    "While more than half of DLBCL patients can be cured with an aggressive chemotherapy regimen, current outcomes for high-risk patients are poor," said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. "We believe we may be able to make a difference for those DLBCL patients by adding the combination of tafasitamab and lenalidomide to R-CHOP, a current standard of care."

    Each year, approximately 30,000 patients are diagnosed with DLBCL in the U.S. alone1,2. R-CHOP is a current standard of care for patients with previously untreated DLBCL, but about 40% of patients do not respond to R-CHOP or relapse – particularly those with high-intermediate and high-risk disease3.

    "Despite improvements in treatment for patients with DLBCL, there continues to be a significant medical need for additional therapies with improved outcomes," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "We are pleased to have initiated the frontMIND study as we seek meaningful, new options for newly diagnosed, high-risk patients with DLBCL."

    In December 2020, encouraging preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of R-CHOP plus either tafasitamab or tafasitamab plus lenalidomide for patients with newly diagnosed DLBCL, were presented at the American Society of Hematology (ASH) Annual Meeting. The data showed a preliminary response rate of 91.1% across both arms in a patient population that overall had a poor prognosis, and that the combination of tafasitamab, lenalidomide and R-CHOP has an acceptable tolerability profile. These results informed and supported further investigation of the tafasitamab combination in the frontMIND study.

    In July 2020, the FDA approved Monjuvi® (tafasitamab-cxix) 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 autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)4.

    The FDA decision represented the first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.

    About Diffuse Large B-cell Lymphoma (DLBCL)

    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide5, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter, leading to a high medical need for new, effective therapies, especially for patients who are not eligible for an autologous stem cell transplant in this setting6.

    About frontMIND

    The frontMIND (NCT04824092) trial is a randomized, double-blind, placebo-controlled, global Phase 3 clinical study in previously untreated high-intermediate and high-risk DLBCL patients that is conducted in partnership with the German Lymphoma Association (GLA), the Italian Lymphoma study group and the US Oncology Network.

    The study aims to enroll approximately 880 DLBCL patients to receive either tafasitamab plus lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-CHOP alone. The primary endpoint is investigator-assessed progression-free survival, according to Lugano 2014 criteria, and key secondary endpoints include event-free survival by investigator, overall survival, metabolic complete response rate by a Blinded Independent Review Committee, and overall response rate.

    For more information about the frontMIND trial, visit https://clinicaltrials.gov/ct2/show/study/NCT04824092?term=NCT04824092&draw=2&rank=1.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration 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). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi® is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi® is a registered trademark of MorphoSys AG.

    XmAb® is a registered trademark of Xencor, Inc.

    Important Safety Information

    What are the possible side effects of MONJUVI?

    MONJUVI may cause serious side effects, including:

    • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
    • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
    • Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

    The most common side effects of MONJUVI include:

    • Feeling tired or weak
    • Diarrhea
    • Cough
    • Fever
    • Swelling of lower legs or hands
    • Respiratory tract infection
    • Decreased appetite

    These are not all the possible side effects of MONJUVI.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

    • Have an active infection or have had one recently.
    • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
      • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
      • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
    • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

    You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

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

    Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

    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.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies which are developed by partners in different areas of unmet medical need. In 2017, Tremfya® (guselkumab) – developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis – became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech, Inc.

    Incyte Forward-looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's ongoing clinical development program for tafasitamab, its frontMIND program, its diffuse large B-cell lymphoma (DLBCL) program generally and whether the combination of tafasitamab and lenalidomide with R-CHOP as first-line treatment will be approved for use in the U.S. or elsewhere for newly diagnosed patients with DLBCL, or any other indication, 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 U.S. FDA and 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; greater than expected expenses; expenses relating to litigation or strategic activities; 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 March 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

    MorphoSys Forward-looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    ______________________________________

    References

    1 Decision Resources Group. Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, Landscape & Forecast. 2020.

    2 Teras, L, et al. 2016 US Lymphoid Malignancy Statistics by World Health Organization Subtypes. CA: A Cancer Journal for Clinicians 2016;66:443–459.

    3 Sehn LH and Salles G. Diffuse Large B-Cell Lymphoma Review. NEJM 2021. https://www.nejm.org/doi/full/10.1056/NEJMra2027612.

    4 Monjuvi® (tafasitamab-cxix) [Package Insert]. Boston, MA: MorphoSys; 2020.

    5 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209–16. doi.org/10.1016/j.beha.2018.07.014.

    6 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.

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  5. Crescendo Biologics Ltd (Crescendo), a clinical-stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announces the appointment of Dr Michael Booth as Chief Financial Officer (CFO). Mike joins with over 20 years' experience in corporate finance within the biopharmaceutical industry.

    Mike joins Crescendo at an important stage of its development, following the initiation of its Phase Ia/Ib trial for Crescendo's lead Humabody® programme, CB307, a first-in-class PSMA x CD137 T cell enhancer. Mike will be responsible for Crescendo's financial strategy and reporting, as well as global investor relations.

    Prior to joining Crescendo, Mike served as Division Vice President, Investor Relations & Corporate Responsibility…

    Crescendo Biologics Ltd (Crescendo), a clinical-stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announces the appointment of Dr Michael Booth as Chief Financial Officer (CFO). Mike joins with over 20 years' experience in corporate finance within the biopharmaceutical industry.

    Mike joins Crescendo at an important stage of its development, following the initiation of its Phase Ia/Ib trial for Crescendo's lead Humabody® programme, CB307, a first-in-class PSMA x CD137 T cell enhancer. Mike will be responsible for Crescendo's financial strategy and reporting, as well as global investor relations.

    Prior to joining Crescendo, Mike served as Division Vice President, Investor Relations & Corporate Responsibility at Incyte (NASDAQ:INCY). Before that, he was Senior Vice President, Communications & Corporate Affairs at Algeta ASA, where he was responsible for corporate communications and capital markets strategies. Prior to Algeta, Mike was Managing Director at The Trout Group, where he helped build the European client base of biotech and healthcare companies, delivering strategic and investor relations consultancy services. He has also held pan-European biotechnology equity research roles at Canaccord, Bank of America, and UBS Investment Bank. Mike earned his DPhil in Neuroscience from the University of Oxford and graduated from the University of St Andrews with a BSc in Psychology.

    "We are delighted to welcome Mike to the team. His proven track record and wide-ranging financial expertise and relationships will be crucial as Crescendo enters its next phase of growth." commented Theodora Harold, CEO of Crescendo. "We now have a highly experienced team in place, committed to progressing our pipeline of innovative, first-in-class, T cell enhancing programmes. I am confident Mike will add tremendous value as Crescendo looks to achieve its full potential."

    Dr Michael Booth, CFO of Crescendo, said: "Crescendo is an ambitious company with a unique platform and an innovative pipeline of T cell enhancing therapeutics. This is a very exciting time to join the team, given that the first clinical trial for CB307, the lead Humabody® programme, is now underway."

    A high-resolution headshot of Dr Michael Booth is available upon request.

    -Ends-

    About Crescendo Biologics

    Crescendo Biologics is a private, clinical-stage immuno-oncology company developing novel, targeted T cell enhancing Humabody® therapeutics.

    Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel half-life extended CD137 x PSMA Humabody® for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anticancer effect whilst avoiding systemic toxicity.

    The Company's ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody® VH). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel biology and superior bio-distribution. This results in larger therapeutic windows compared to conventional IgG approaches. Humabody®-based formats can also be applied across a range of non-cancer indications.

    Beyond Crescendo's proprietary pipeline, the Company has a global, multi-target discovery and development collaboration with Takeda, a clinical development partnership with Cancer Research UK and an exclusive, worldwide licensing agreement with Zai Lab.

    Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital and Astellas.

    For more information, please visit www.crescendobiologics.com and follow @HUMABODY.

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