MOR MorphoSys AG

32.99
-0.4  -1%
Previous Close 33.39
Open 33.25
52 Week Low 18.21
52 Week High 37.9609
Market Cap $4,310,373,902
Shares 130,656,984
Float 130,656,984
Enterprise Value $3,298,076,244
Volume 122,280
Av. Daily Volume 126,235
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Upcoming Catalysts

Drug Stage Catalyst Date
Tafasitamab (MOR208/XmAb5574)
Relapsed or refractory diffuse large B cell lymphoma
PDUFA priority review
PDUFA priority review
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Bendamustine + MOR208 - B-MIND
Relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Guselkumab (NOVA)
Hidradenitis Suppurativa
Phase 2
Phase 2
Phase 2 trial initiation announced November 19, 2018.
Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis
Phase 3
Phase 3
Phase 3 ContRAst trial initiation announced July 3, 2019.
MOR202
Membranous nephropathy
Phase 1/2
Phase 1/2
Phase 1/2 enrolment and screening has been paused due to COVID-19.
MOR106 IGUANA
Atopic dermatitis
Phase 2
Phase 2
Phase 2 trial halted due to futility - October 28, 2019.
MOR208 tafasitamab
Front-line diffuse large B cell lymphoma (DLBCL)
Phase 1b
Phase 1b
Phase 1b initiation of dosing announced December 27, 2019.
MOR208 + idelalisib (COSMOS)
Chronic Lymphocytic Leukemia
Phase 2
Phase 2
Phase 2 data presented at ASH December 7, 2019.
Guselkumab
Psoriatic Arthritis
sNDA Filing
sNDA Filing
sBLA filing announced September 16, 2019.
Guselkumab vs Cosentyx - ECLIPSE
Psoriasis
Phase 3
Phase 3
Phase 3 primary endpoint met - December 12, 2018.
Gantenerumab
Early Alzheimer's disease
Phase 3
Phase 3
Phase 3 enrollment has commenced - noted June 14, 2018.
Guselkumab (GALAXI 1)
Crohn's disease
Phase 2/3
Phase 2/3
Phase 2/3 trial initiation announced July 11, 2018.
Guselkumab
Ulcerative colitis
Phase 2
Phase 2
Phase 2a initiation announced January 17, 2019.
Guselkumab
Plaque psoriasis
Approved
Approved
Approval announced February 27, 2019.

Latest News

  1. PLANEGG and MUNICH, GERMANY / ACCESSWIRE / June 2, 2020 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) will present at the following virtual conferences:

    Jefferies Healthcare Conference
    Date: June 3, 2020, 9:30am EDT (3:30pm CEST, 2:30pm BST)
    Presenter: Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys,
    Dr. Julia Neugebauer, Director Corporate Communications & IR

    Goldman Sachs 41st Annual Global Healthcare Conference
    Date: June 10, 2020, 8:50am EDT (2:50pm CEST, 1:50pm BST)
    Presenter: Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys,
    Dr. Julia Neugebauer, Director Corporate Communications & IR

    J.P. Morgan European Healthcare Conference
    Date: June 18, 2020
    Presenter: Jens Holstein, Chief Financial Officer of MorphoSys,
    Dr. Julia Neugebauer…

    PLANEGG and MUNICH, GERMANY / ACCESSWIRE / June 2, 2020 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) will present at the following virtual conferences:

    Jefferies Healthcare Conference
    Date: June 3, 2020, 9:30am EDT (3:30pm CEST, 2:30pm BST)
    Presenter: Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys,
    Dr. Julia Neugebauer, Director Corporate Communications & IR

    Goldman Sachs 41st Annual Global Healthcare Conference
    Date: June 10, 2020, 8:50am EDT (2:50pm CEST, 1:50pm BST)
    Presenter: Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys,
    Dr. Julia Neugebauer, Director Corporate Communications & IR

    J.P. Morgan European Healthcare Conference
    Date: June 18, 2020
    Presenter: Jens Holstein, Chief Financial Officer of MorphoSys,
    Dr. Julia Neugebauer, Director Corporate Communications & IR

    JMP Hematology and Oncology Forum
    Date: June 18, 2020
    Presenter: Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys,
    Dr. Julia Neugebauer, Director Corporate Communications & IR

    PDF versions of the presentations will be provided at www.morphosys.com. Links to available webcasts will be filed under www.morphosys.com/conference-calls.

    About MorphoSys
    MorphoSys ((FSE &amp, NASDAQ:MOR) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. MorphoSys most advanced proprietary product candidate, tafasitamab (MOR208), is in late-stage clinical development for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com

    HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R), LanthioPep(R) and ENFORCER(R) are trademarks of the MorphoSys Group. Tremfya(R) is a trademark of Janssen Biotech, Inc. XmAb(R) is a trademark of Xencor, Inc.

    For more information, please contact:

    MorphoSys

    Investor Contact:

    Dr. Julia Neugebauer
    Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-179

    Media Contacts:

    Dr. Anca Alexandru
    Associate Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-26738

    Dr. Verena Kupas
    Associate Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-26814

    SOURCE: MorphoSys AG

    View source version on accesswire.com:
    https://www.accesswire.com/592481/MorphoSys-to-Present-at-Upcoming-Virtual-Investor-Conferences

    View Full Article Hide Full Article
  2. The MAA seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

    MUNICH, GERMANY / ACCESSWIRE / May 20, 2020 / MorphoSys AG (FSE:MOR) Prime Standard Segment; MDAX & TecDAX; (NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous…

    The MAA seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

    MUNICH, GERMANY / ACCESSWIRE / May 20, 2020 / MorphoSys AG (FSE:MOR) Prime Standard Segment; MDAX & TecDAX; (NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process.

    "The EMA's validation of the MAA for tafasitamab is a critical step on the path to making tafasitamab available for use in combination with lenalidomide in eligible patients with r/r DLBCL in Europe," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "We will continue to work closely with the EMA to progress the review of this application, with the hope of bringing this novel therapy to eligible patients as soon as possible."

    "We are pleased to have achieved this important milestone, which moves tafasitamab in combination with lenalidomide into the formal regulatory review process in the European Union," said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. "Following the U.S. FDA's acceptance of our Biologics License Application filing for tafasitamab for Priority Review earlier this year, this represents another major step forward. We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients in need."

    The MAA, submitted by MorphoSys, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with r/r DLBCL; and is supported by the Re-MIND study, an observational retrospective study in r/r DLBCL. If approved, Incyte will hold the marketing authorization, and has exclusive commercialization rights for tafasitamab outside of the United States, including Europe.

    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide - comprising 40% of all cases1. It is an aggressive disease affecting the B-cells of the immune system with 30-40% of patients who do not respond to initial therapy or relapse thereafter, leading to a high medical need for new, effective therapies2.

    About L-MIND
    The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study's primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Two-year data, assessed by an independent review committee (November 30, 2019 cut-off), evaluating 80 patients receiving tafasitamab and lenalidomide corroborate previously reported primary analysis data.
    For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.

    About Re-MIND
    Re-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND was met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.
    For more information about Re-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

    About Tafasitamab
    Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing.

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States. Incyte has exclusive commercialization rights outside the United States.

    Tafasitamab is being studied as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND, as well as the ongoing Phase 3 B-MIND study evaluating the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being evaluated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.
    XmAb(R) is a trademark of Xencor, 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.

    About MorphoSys
    MorphoSys is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 28 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has over 400 employees. More information at www.morphosys.com.

    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: whether tafasitamab will be approved for use in humans anywhere in Europe, the U.S. or elsewhere or will be commercialized in Europe, the U.S. or elsewhere successfully or at all; whether tafasitamab will be effective in the treatment of the indications discussed in this press release; and the expectations, timing and potential results of further development activities involving tafasitamab. 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 Incyte's annual report on Form 10-Q for the quarter ending March 31, 2020 and MorphoSys' Annual Report on Form 20-F for the fiscal year ended December 31, 2019. Each party 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 the licensing agreements for tafasitamab, the further clinical development of Tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab. 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 the licensing agreements for tafasitamab, the further clinical development of tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab, 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 US 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. 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.

    2. 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.

    For more information, please contact:

    Incyte

    Media Contacts:

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

    Ela Zawislak
    Director, Public Affairs
    Tel: + 41 21 343 3113

    Investor Contact:

    Dr. Michael Booth
    Division VP, IR & Global Responsibility
    Tel.: +1 302 498 5914

    MorphoSys

    Media Contacts:

    Dr. Anca Alexandru
    Associate Director, Corporate & IR
    Tel: +49 (0) 89 / 899 27-26738

    Dr. Verena Kupas
    Associate Director Corporate
    Communications & IR
    Tel: +49 (0) 89 / 899 27-26814

    Investor Contact:

    Dr. Julia Neugebauer
    Director Corporate Communications & IR
    Tel.: +49 (0) 89 / 899 27-179

    Additional features:

    Document: https://eqs-cockpit.com/c/fncls.ssp?u=CPKUEVJDTM
    Document title: Media Release

    SOURCE: MorphoSys AG

    View source version on accesswire.com:
    https://www.accesswire.com/590724/MorphoSys-and-Incyte-Announce-the-Validation-of-the-European-Marketing-Authorization-Application-for-Tafasitamab

    View Full Article Hide Full Article
  3. - The MAA seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The…

    - The MAA seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200520005746/en/

    "The EMA's validation of the MAA for tafasitamab is a critical step on the path to making tafasitamab available for use in combination with lenalidomide in eligible patients with r/r DLBCL in Europe," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "We will continue to work closely with the EMA to progress the review of this application, with the hope of bringing this novel therapy to eligible patients as soon as possible."

    "We are pleased to have achieved this important milestone, which moves tafasitamab in combination with lenalidomide into the formal regulatory review process in the European Union," said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. "Following the U.S. FDA's acceptance of our Biologics License Application filing for tafasitamab for Priority Review earlier this year, this represents another major step forward. We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients in need."

    The MAA, submitted by MorphoSys, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with r/r DLBCL; and is supported by the Re-MIND study, an observational retrospective study in r/r DLBCL. If approved, Incyte will hold the marketing authorization, and has exclusive commercialization rights for tafasitamab outside of the United States, including Europe.

    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide – comprising 40% of all cases1. It is an aggressive disease affecting the B-cells of the immune system with 30-40% of patients who do not respond to initial therapy or relapse thereafter, leading to a high medical need for new, effective therapies2.

    About L-MIND

    The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study's primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Two-year data, assessed by an independent review committee (November 30, 2019 cut-off), evaluating 80 patients receiving tafasitamab and lenalidomide corroborate previously reported primary analysis data.

    For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.

    About Re-MIND

    Re-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND was met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

    For more information about Re-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

    About Tafasitamab

    Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing.

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States. Incyte has exclusive commercialization rights outside the United States.

    Tafasitamab is being studied as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND, as well as the ongoing Phase 3 B-MIND study evaluating the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being evaluated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

    XmAb® is a trademark of Xencor, 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.

    About MorphoSys

    MorphoSys is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 28 of which are currently in clinical development. In 2017, Tremfya®, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has over 400 employees. More information at www.morphosys.com.

    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: whether tafasitamab will be approved for use in humans anywhere in Europe, the U.S. or elsewhere or will be commercialized in Europe, the U.S. or elsewhere successfully or at all; whether tafasitamab will be effective in the treatment of the indications discussed in this press release; and the expectations, timing and potential results of further development activities involving tafasitamab. 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 Incyte's annual report on Form 10-Q for the quarter ending March 31, 2020 and MorphoSys' Annual Report on Form 20-F for the fiscal year ended December 31, 2019. Each party 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 the licensing agreements for tafasitamab, the further clinical development of Tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab. 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 the licensing agreements for tafasitamab, the further clinical development of tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab, 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 US 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. 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.
    2. 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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  4. PLANEGG/MUNICH, GERMANY / ACCESSWIRE / May 14, 2020 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) announced today that multiple abstracts from the Company's tafasitamab program have been accepted for oral and poster presentations at the upcoming 2020 American Society of Clinical Oncology (ASCO) Virtual Meeting, May 29 - May 31, 2020 and at the virtual 25th Congress of the European Hematology Association (EHA25 Virtual), June 11-14, 2020. Tafasitamab is MorphoSys' investigational anti-CD19 antibody, currently under priority review by the FDA in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).

    "We are excited to provide a number of important…

    PLANEGG/MUNICH, GERMANY / ACCESSWIRE / May 14, 2020 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) announced today that multiple abstracts from the Company's tafasitamab program have been accepted for oral and poster presentations at the upcoming 2020 American Society of Clinical Oncology (ASCO) Virtual Meeting, May 29 - May 31, 2020 and at the virtual 25th Congress of the European Hematology Association (EHA25 Virtual), June 11-14, 2020. Tafasitamab is MorphoSys' investigational anti-CD19 antibody, currently under priority review by the FDA in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).

    "We are excited to provide a number of important updates on tafasitamab in this new virtual setting," commented Dr. Malte Peters, Chief Research and Development Officer of MorphoSys. "The data we and our partners will present highlight our progress towards making novel therapies available to eligible patients in need as soon as possible."

    MorphoSys will meet registered ASCO20 Virtual and EHA25 Virtual attendees at its virtual booths accessible through the conference websites.

    Key abstracts accepted for presentation at ASCO20 Virtual and EHA25 Virtual include:

    ASCO20 Virtual

    E-Poster Presentation

    RE-MIND STUDY: A PROPENSITY SCORE-BASED 1:1 MATCHED COMPARISON OF TAFASITAMAB + LENALIDOMIDE (L-MIND) VERSUS LENALIDOMIDE MONOTHERAPY (REAL-WORLD DATA) IN TRANSPLANT-INELIGIBLE PATIENTS WITH RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

    Abstract/Poster No.: 8020/353
    Session: Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia
    Presentation Time: Friday, May 29, 2020, 8:00 AM EDT

    EHA25 Virtual

    Oral Presentation

    RE-MIND STUDY: COMPARISON OF TAFASITAMAB + LENALIDOMIDE (L-MIND) VS LENALIDOMIDE MONOTHERAPY (REAL-WORLD DATA) IN TRANSPLANT-INELIGIBLE PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

    Abstract No.: S238
    Session: 19. Aggressive Non-Hodgkin lymphoma - Clinical
    Presentation Time: Friday, June 12, 8:30 CEST

    E-Poster Presentations:

    LONG-TERM OUTCOMES FROM THE PHASE II L-MIND STUDY OF TAFASITAMAB (MOR208) PLUS LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

    Abstract No.: EP1201
    Session: 19. Aggressive Non-Hodgkin lymphoma - Clinical
    Presentation Time: Friday, June 12, 8:30 CEST

    EXPRESSION OF CD19 ANTIGEN ON CHRONIC LYMPHOCYTIC LEUKEMIA CELLS AFTER TAFASITAMAB (ANTI-CD19) TREATMENT: PHASE I TRIAL DATA

    Abstract No.: EP671
    Session: 05. Chronic lymphocytic leukemia and related disorders - Biology & Translational Research
    Presentation Time: Friday, June 12, 8:30 CEST

    COMBINATION OF TAFASITAMAB (MOR208) AND LENALIDOMIDE ENHANCES TUMOR CELL DEATH OF B-CELL LYMPHOMA IN VITRO
    Abstract No.: EP1343
    Session: 20. Lymphoma Biology & Translational Research
    Presentation Time: Friday, June 12, 8:30 CEST

    Please refer to the ASCO20 Virtual (https://meetinglibrary.asco.org) and EHA25 Virtual (https://learningcenter.ehaweb.org/eha) online programs for full session details and data presentation listings.

    About tafasitamab

    Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved in the U.S., MorphoSys and Incyte will co-commercialize tafasitamab; Incyte will have exclusive commercialization rights outside the U.S. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND. Additionally, tafasitamab is being evaluated as part of the ongoing Phase 3 study B-MIND study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. Tafasitamab is also currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

    About MorphoSys

    MorphoSys ((FSE &amp, NASDAQ:MOR) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. MorphoSys most advanced proprietary product candidate, tafasitamab (MOR208), is in late-stage clinical development for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has over 400 employees. More information at www.morphosys.com.

    HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R), LanthioPep(R) and ENFORCER(R) are trademarks of the MorphoSys Group. Tremfya(R) is a trademark of Janssen Biotech, Inc. XmAb(R) is a trademark of Xencor, Inc.

    MorphoSys forward-looking statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding the licensing agreements for tafasitamab, the further clinical development of Tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab. 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 the licensing agreements for tafasitamab, the further clinical development of tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab, 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 US 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.

    For more information, please contact:

    MorphoSys

    Investor Contact:
    Dr. Julia Neugebauer
    Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-179
    Media Contacts:
    Dr. Anca Alexandru
    Associate Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-26738
    Dr. Verena Kupas
    Associate Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-26814

    SOURCE: MorphoSys AG

    View source version on accesswire.com:
    https://www.accesswire.com/589893/MorphoSys-to-Present-Data-on-Tafasitamab-at-the-ASCO-and-EHA-Virtual-Meetings

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    • New two-year follow-up data (November 30, 2019 cut-off) of L-MIND trial corroborate previously reported primary analysis
    • Updated IRC efficacy outcomes include objective response rate (ORR) of 58.8%, complete response (CR) rate of 41.3%
    • Median duration of response (mDOR) of 34.6 months, median progression-free survival (mPFS) of 16.2 months, and median overall survival (mOS) of 31.6 months
    • Full efficacy and safety data to be presented virtually at the 25th EHA Annual Congress

    PLANEGG/MUNICH, GERMANY and WILMINGTON, DE / ACCESSWIRE / May 14, 2020 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (INCY) today reported updated results from the ongoing Phase 2 L-MIND study investigating the combination of…

    • New two-year follow-up data (November 30, 2019 cut-off) of L-MIND trial corroborate previously reported primary analysis
    • Updated IRC efficacy outcomes include objective response rate (ORR) of 58.8%, complete response (CR) rate of 41.3%
    • Median duration of response (mDOR) of 34.6 months, median progression-free survival (mPFS) of 16.2 months, and median overall survival (mOS) of 31.6 months
    • Full efficacy and safety data to be presented virtually at the 25th EHA Annual Congress

    PLANEGG/MUNICH, GERMANY and WILMINGTON, DE / ACCESSWIRE / May 14, 2020 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (INCY) today reported updated results from the ongoing Phase 2 L-MIND study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). The results, based on a November 30, 2019 data cut-off, corroborate previously reported primary analysis data.

    In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis. After a minimum of two years' follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response (DoR) and overall survival (OS) of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with r/r DLBCL. Assessment by an independent review committee (IRC) at data cut-off showed an objective response rate (ORR) of 58.8% (47 out of 80 patients) and a complete response (CR) rate of 41.3% (33 out of 80 patients). Median duration of response (mDOR) was 34.6 months, with median overall survival (mOS) of 31.6 months and median progression-free survival (mPFS) of 16.2 months. The safety profile was consistent with that observed in previously reported studies of tafasitamab in combination with lenalidomide. The full analysis will be presented virtually at the 25th EHA Annual Congress to be held June 11-14, 2020.

    "We are extremely encouraged by the long-term data from our L-MIND study which confirms the previously reported results from the primary analysis," commented Dr. Malte Peters, Chief Research and Development Officer, MorphoSys. "Tafasitamab in combination with lenalidomide has the potential to address the significant medical need in patients suffering from r/r DLBCL, and we are working diligently towards our key priority of making tafasitamab available to eligible patients."

    "The updated data for L-MIND reinforce the potential of tafasitamab in combination with lenalidomide as treatment for patients with r/r DLBCL. We look forward to working with our partners at MorphoSys as we seek to bring this new therapeutic option to eligible patients globally," Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte.

    A Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for r/r DLBCL is currently under Priority Review by the U.S. Food and Drug Administration (FDA) (PDUFA action date August 30, 2020). The BLA is based on data including the primary analysis of L-MIND with a previous cut-off date as of November 30, 2018, and the primary analysis data from the retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received lenalidomide monotherapy.

    In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States while Incyte has exclusive commercialization rights outside the United States.

    About L-MIND

    L-MIND is a single arm, open-label Phase 2 study, investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study's primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Primary analysis data with a cut-off date of November 30, 2018 included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update were based on response rates assessed by an independent review committee for all 80 patients.

    About Re-MIND

    Re-MIND, an observational retrospective study, was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

    About tafasitamab

    Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved in the U.S., MorphoSys and Incyte will co-commercialize tafasitamab; Incyte will have exclusive commercialization rights outside the U.S. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND. Additionally, tafasitamab is being evaluated as part of the ongoing Phase 3 study B-MIND study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. Tafasitamab is also currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

    About MorphoSys

    MorphoSys ((FSE &amp, NASDAQ:MOR) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. MorphoSys most advanced proprietary product candidate, tafasitamab (MOR208), is in late-stage clinical development for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has over 400 employees. More information at www.morphosys.com.

    HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R), LanthioPep(R) and ENFORCER(R) are trademarks of the MorphoSys Group. Tremfya(R) is a trademark of Janssen Biotech, Inc. XmAb(R) is a trademark of Xencor, 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 the licensing agreements for tafasitamab, the further clinical development of Tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab. 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 the licensing agreements for tafasitamab, the further clinical development of tafasitamab including the L-MIND and Re-MIND studies, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for tafasitamab as well as the potential future commercialization of tafasitamab, 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 US 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 contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether tafasitamab will be approved for use in humans anywhere in Europe, the U.S. or elsewhere or will be commercialized in Europe, the U.S. or elsewhere successfully or at all; whether tafasitamab will be effective in the treatment of the indications discussed in this press release; and the expectations, timing and potential results of further development activities involving tafasitamab. 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 Incyte's annual report on Form 10-Q for the quarter ending March 31, 2020 and MorphoSys' Annual Report on Form 20-F for the fiscal year ended December 31, 2019 Each party disclaims any intent or obligation to update these forward-looking statements.

    # # #

    For more information, please contact:

    MorphoSys

    Investor Contact:
    Dr. Julia Neugebauer
    Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-179
    Media Contacts:
    Dr. Anca Alexandru
    Associate Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-26738
    Dr. Verena Kupas
    Associate Director Corporate Communications & IR
    Tel: +49 (0) 89 / 899 27-26814

    Incyte

    Investor Contact:

    Dr. Michael Booth
    Division Vice President, Investor Relations & Corporate Responsibility
    Tel: +1 302 498 5914

    Media Contacts:

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

    Ela Zawislak
    Director, Public Affairs
    Tel: + 41 21 343 3113

    SOURCE: MorphoSys AG

    View source version on accesswire.com:
    https://www.accesswire.com/589875/MorphoSys-and-Incyte-Announce-Long-term-Follow-up-Results-from-L-MIND-Study-of-Tafasitamab-in-Patients-with-rr-DLBCL

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