MORPHOSYS

DGAP-News: MorphoSys and Incyte Announce Swissmedic Temporary Approval of Minjuvi(R) (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with r/r DLBCL

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Friday, April 1, 2022
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"The approval of Minjuvi by Swissmedic is excellent news," said Jonathan Dickinson, Executive Vice President and General Manager, Incyte Europe.

Key Points: 
  • "The approval of Minjuvi by Swissmedic is excellent news," said Jonathan Dickinson, Executive Vice President and General Manager, Incyte Europe.
  • "Minjuvi addresses this unmet need and its approval in Switzerland is a crucial milestone for these patients."
  • Tafasitamab together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable.
  • DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases [3] .

MorphoSys AG Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

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Wednesday, March 16, 2022
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MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the fourth quarter and full year 2021.

Key Points: 
  • MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the fourth quarter and full year 2021.
  • Monjuvi (tafasitamab-cxix) U.S. net product sales of 20.5 million (US$ 23.6 million) for the fourth quarter of 2021 and 66.9 million (US$ 79.1 million) for the full year of 2021.
  • Minjuvi Royalty revenue of 0.6 million for sales outside of the U.S. in the fourth quarter of 2021.
  • Total revenues for the fourth quarter of 2021 were 52.9 million compared to 36.0 million for the same period in 2020.

DGAP-News: MorphoSys AG Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 16, 2022
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Monjuvi (tafasitamab-cxix) U.S. net product sales of 20.5 million (US$ 23.6 million) for the fourth quarter of 2021 and 66.9 million (US$ 79.1 million) for the full year of 2021.

Key Points: 
  • Monjuvi (tafasitamab-cxix) U.S. net product sales of 20.5 million (US$ 23.6 million) for the fourth quarter of 2021 and 66.9 million (US$ 79.1 million) for the full year of 2021.
  • Minjuvi(R) Royalty revenue of 0.6 million for sales outside of the U.S. in the fourth quarter of 2021.
  • Enrollment of first patient in Phase 3 trial evaluating tafasitamab and lenalidomide in addition to R-CHOP in first-line DLBCL patients.
  • Total revenues for the fourth quarter of 2021 were 52.9 million compared to 36.0 million for the same period in 2020.

DGAP-News: National Comprehensive Cancer Network(R) Updates Designation of Monjuvi(R) (tafasitamab-cxix) to Preferred Regimen in its Clinical Practice Guidelines in Oncology for B-cell Lymphomas

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Tuesday, March 15, 2022
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"Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma.

Key Points: 
  • "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma.
  • We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."
  • This indication is approved under accelerated approval based on overall response rate (ORR) from the one-year primary analysis of the L-MIND study.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

DGAP-News: MorphoSys presents latest data from the Phase 2 MANIFEST Study evaluating the potential of pelabresib in the treatment of myelofibrosis

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Monday, December 20, 2021
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These latest results, which included more patients and longer-term follow-up than previously reported data, suggest the potential of pelabresib in the treatment of myelofibrosis.

Key Points: 
  • These latest results, which included more patients and longer-term follow-up than previously reported data, suggest the potential of pelabresib in the treatment of myelofibrosis.
  • "We are further exploring the effectiveness and safety of pelabresib as a first-line treatment for myelofibrosis in MANIFEST-2, an ongoing Phase 3 study.
  • At the time of the data cut-off, 53 patients (63 percent of the 84 patients) were still on treatment.
  • The exploratory data, which require further evaluation, suggest the potential pelabresib may have in changing the course of myelofibrosis treatment, if approved.

MorphoSys and Incyte Announce Additional Real-World Evidence Results from RE-MIND2 Study of Tafasitamab (Monjuvi®) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Retrieved on: 
Saturday, December 11, 2021
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Findings from the RE-MIND2 study presented at ASH 2021 indicated that tafasitamab plus lenalidomide resulted in statistically significant differences across several endpoints.

Key Points: 
  • Findings from the RE-MIND2 study presented at ASH 2021 indicated that tafasitamab plus lenalidomide resulted in statistically significant differences across several endpoints.
  • Specifically, results showed:
    A comparable median OS benefit was observed with tafasitamab plus lenalidomide at 22.5 months compared to CAR-T at 15 months without statistical significance.
  • Objective response rate (ORR), a key secondary endpoint, was observed with statistical significance for tafasitamab plus lenalidomide at 63.6% versus R2 at 30.3% (p=0.013).
  • Tafasitamab plus lenalidomide also achieved significantly higher complete response rate (CR), a key secondary endpoint, at 39.4% versus 15.2% for R2 (p=0.0514).

DGAP-News: MorphoSys Announces Departure of Roland Wandeler

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Tuesday, November 9, 2021
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Planegg/Munich, Germany, November 9, 2021 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that Roland Wandeler, Ph.D., has decided to step down from his position as Chief Operating Officer (COO) and member of the MorphoSys Management Board effective December 31, 2021 to pursue other opportunities.

Key Points: 
  • Planegg/Munich, Germany, November 9, 2021 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that Roland Wandeler, Ph.D., has decided to step down from his position as Chief Operating Officer (COO) and member of the MorphoSys Management Board effective December 31, 2021 to pursue other opportunities.
  • "MorphoSys is now well positioned to continue its growth journey and bring breakthrough therapies to people living with cancer."
  • "It has been my honor to work with the exceptional team at MorphoSys," said Roland Wandeler.
  • Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees.

DGAP-News: MorphoSys presents interim results from M-PLACE study with felzartamab during American Society of Nephrology Annual Meeting

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Thursday, November 4, 2021
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MorphoSys AG (FSE: MOR; NASDAQ: MOR) presented interim results from the M-PLACE study with felzartamab at the 2021 Annual Meeting of the American Society of Nephrology (ASN) on November 4-7.

Key Points: 
  • MorphoSys AG (FSE: MOR; NASDAQ: MOR) presented interim results from the M-PLACE study with felzartamab at the 2021 Annual Meeting of the American Society of Nephrology (ASN) on November 4-7.
  • Of the 27 treated patients with evaluable results, 24 showed an initial rapid reduction of anti-PLA2R antibody levels one week after the first treatment.
  • Safety profile was consistent with the proposed mechanism of action of felzartamab and treatment-emergent adverse events were manageable.
  • Felzartamab (MOR202/TJ202) is a therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38.

DGAP-News: MorphoSys to present MANIFEST and RE-MIND2 data from expanded hematology-oncology portfolio at the 2021 American Society of Hematology (ASH) Annual Meeting

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Thursday, November 4, 2021
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Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Key Points: 
  • 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.
  • Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees.
  • Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

DGAP-News: MorphoSys AG: First Patient Dosed in Phase 2 IGNAZ Study of Felzartamab in Patients with Immunoglobulin A Nephropathy

Retrieved on: 
Wednesday, October 20, 2021
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MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with Immunoglobulin A Nephropathy (IgAN).

Key Points: 
  • MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with Immunoglobulin A Nephropathy (IgAN).
  • "Dosing of the first IgAN patient is an exciting milestone for MorphoSys, physicians and patients alike as we are rapidly broadening our development program for felzartamab."
  • Felzartamab (MOR202) is an investigational therapeutic human monoclonal antibody derived from MorphoSys' HuCAL(R) antibody library and directed against CD38.
  • By targeting CD38, felzartamab has the potential to deplete the CD38 positive plasma cells, which may ultimately improve the patient's kidney functions.