DE-INCYTE
5.2.2024 22:47:32 CET | Business Wire | Press release
Incyte (Nasdaq:INCY) announced it has entered into an asset purchase agreement with MorphoSys AG (FSE: MOR; NASDAQ: MOR) which gives Incyte exclusive global rights for tafasitamab, a humanized Fc-modified CD19-targeting immunotherapy marketed in the U.S. as Monjuvi® (tafasitamab-cxix) and outside of the U.S. as Minjuvi® (tafasitamab).
“This new agreement with MorphoSys provides Incyte with exclusive global rights to tafasitamab and full control over its development and commercialization, allowing us to realize significant operating efficiencies and cost synergies,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
In the previous agreement, MorphoSys and Incyte were collaborating and sharing costs for the clinical development and commercialization of tafasitamab in the U.S.; Incyte had exclusive rights outside of the U.S. Under the terms of the new agreement, MorphoSys will receive a payment of $25 million from Incyte and Incyte will gain global development and commercialization rights for tafasitamab. Incyte will now recognize revenue and cost for all U.S. commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. The agreement is effective immediately.
In addition to its approved indication, tafasitamab is being evaluated as a therapeutic option in ongoing pivotal trials for first-line DLBCL, relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL).
About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19-targeting immunotherapy. 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).
In the United States, 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 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). Please see the U.S. full Prescribing Information for Monjuvi for important safety information.
In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational uses have not been established in pivotal trials.
Monjuvi® and Minjuvi® are registered trademarks of Incyte. Tafasitamab is marketed by under the brand name Monjuvi® in the U.S., and under the brand name Minjuvi® in the EU and Canada.
XmAb® is a registered trademark of Xencor, Inc.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Incyte Forward-looking Statements
Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the operating efficiencies and cost synergies Incyte expects to gain by virtue of this transaction; Incyte’s expectations regarding revenue and cost for U.S. commercialization and clinical development of tafasitamab; and the potential for tafasitamab as a therapeutic option in first-line DLBCL, relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL).
These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: obtaining regulatory approval for this planned collaboration; research and development efforts related to the collaboration programs; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors, including other scientific developments; unanticipated delays; the effects of market competition; risks associated with relationships between collaboration partners; the impact of governmental actions regarding pricing, importation and reimbursement for pharmaceuticals; and such other risks detailed from time to time in each company's reports filed with the Securities and Exchange Commission, including our annual report and our quarterly report on Form 10-Q for the quarter ended September 30, 2023. We disclaim any intent or obligation to update these forward-looking statements.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240205431773/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Estithmar Holding Pays the Third Semi-Annual coupon of the 8.75% Sukuk Tranche12.3.2026 21:50:00 CET | Press release
Estithmar Holding Q.P.S.C. has paid the third semi-annual coupon of its Qatari Riyal-denominated Sukuk (first tranche), at an annual profit rate of 8.75%. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312880092/en/ Estithmar Holding Pays the Third Semi-Annual coupon of the 8.75% Sukuk Tranche (Photo: AETOSWire) The first tranche, part of the company’s broader Sukuk program valued at QAR 3.4 billion and listed on the London Stock Exchange’s International Securities Market, was issued in August 2024. The issuance attracted a diverse pool of institutional investors including banks, insurance companies, and asset managers, with strong interest from both government-affiliated and private institutions. This demand reflects growing investor confidence in Estithmar Holding’s ability to deliver sustained value to stakeholders. EstithmarHolding was recently included in the FTSE Russell Global Equity Index, in Qatar’s Mid-Cap segme
Andersen Consulting styrker sine kompetencer i samarbejde med Acumen Learning12.3.2026 21:36:00 CET | Pressemeddelelse
Andersen Consulting udvider sin platform gennem en samarbejdsaftale med Acumen Learning, en amerikansk virksomhed, der specialiserer sig i træning i forretnings- og økonomiforståelse med henblik på lederudvikling og salgsresultater. Acumen Learning blev stiftet i 2002 og samarbejder med Fortune 500-virksomheder for en bedre finansiel forståelse, strategisk tænkning og beslutningstagning på alle niveauer. Med udgangspunkt i principperne fra deres bestsellerbøger "Seeing the Big Picture" og "Business Acumen for Sales Success" klæder deres programmer ledere og teams på til at afstemme beslutninger med virksomhedsstrategier, fremme resultater og styrke kunderelationer. Acumen Learning er målrettet brancher som sundhedssektoren, energi og teknologi og giver fagfolk mulighed for at omsætte forretningsviden til håndgribelige resultater. "Hos Acumen Learning er vores mission at styrke det enkelte menneske ved at skabe forretningskyndige fagfolk, der gør en forskel i deres karrierer," udtalte K
REPLY: The Board of Directors Approved the Draft Financial Statements for the Year 202512.3.2026 15:38:00 CET | Press release
All economic indicators are positive.Consolidated turnover of €2,483.6 million (€2,300.5 million in 2024);EBITDA at €467.6 million (€410.6 million in 2024);EBIT at €391.7 million (€330.4 million in 2024)Group net profit at €250.9 million (€211.1 million in 2024)Approval of the proposed dividend distribution of €1.35 per share. Today the Board of Directors of Reply S.p.A. [MTA, STAR: REY] approved the draft financial statement for the year 2025, which will be submitted for approval to the Shareholders’ Meeting to be held in first call in Turin on 23 April 2026. The Reply Group closed 2025 with a consolidated turnover of €2,483.6 million, an increase of 8.0% compared to €2,300.5 million in 2024. All indicators are positive for the period. Consolidated EBITDA was €467.6 million, an increase of 13.9% compared to €410.6 million at December 2024. EBIT, from January to December, was at €391.7 million, which is an increase of 18.5% compared to €330.4 million at December 2024. The Group net pro
LZE GmbH Introduces Fraunhofer’s RFicient® Technology to the Market12.3.2026 14:51:00 CET | Press release
LZE GmbH is expanding its technology transfer portfolio and making the RFicient® ultra-low-power wake-up receiver technology from the Fraunhofer Institute for Integrated Circuits IIS available for the first time as a standard chip for close-to-production industrial applications. The solution enables energy-efficient IoT designs that remain continuously reachable while consuming only microamps – a key step for long-lasting, low-maintenance IoT products. LZE GmbH drives technology transfer to market: standard chip availability for close-to-production applications As a bridge between research and industry, LZE GmbH is making it easier for companies to access innovative technologies and helping them to quickly and reliably transform new developments into market-ready solutions. With RFicient®-IC (FH101RF), LZE is providing another high-tech product that comes directly from Fraunhofer research and can now be ordered in volume and integrated into close-to-production product development for t
Owkin Creates New Spin out Waiv, Formerly Owkin Dx, With $33M Financing12.3.2026 14:30:00 CET | Press release
Investment lead by OTB Ventures and Alpha Intelligence CapitalWaiv develops AI-powered precision testing to better identify and stratify patients in the clinic and in clinical trials, transforming patient careWaiv extends Owkin’s strategy of real-world validation for its AI Owkin, the AI company on a mission to solve the complexity of biology, today announced the spin out of Waiv, formerly known as Owkin Dx. The move follows significant investor interest and positions Waiv to bring AI-powered precision testing for better identification of patients in the clinic and in clinical trials, to transform patient care. This follows on from the successful launch of Bioptimus, an Owkin incubated company, in February 2024. Waiv translates AI innovation into real-world clinical impact, developing tests that predict biomarkers and patient outcomes, including RlapsRisk BC for prognostic risk profiling. With multiple tests already in use in clinical settings, its deployment platform Destra, and colla
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
