Blastic plasmacytoid dendritic cell neoplasm

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
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ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.
  • We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα.
  • Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022.
  • Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
MHLW, Patient, Blastic plasmacytoid dendritic cell neoplasm, Orphan, Menarini, Therapy, BPDCN, Pharmaceutical industry, Health

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
MHLW, Patient, Blastic plasmacytoid dendritic cell neoplasm, Orphan, Menarini, Therapy, BPDCN, Pharmaceutical industry, Health

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

ImmunoGen Announces Clinical Collaboration with Gilead to Evaluate Pivekimab Sunirine in Combination with Magrolimab in Relapsed/Refractory Acute Myeloid Leukemia

Retrieved on: 
Friday, December 9, 2022
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Expected to initiate in 2023, the collaboration will be a new cohort in ImmunoGen's 802 study and will evaluate pivekimab in combination with magrolimab in up to 42 patients with R/R CD123-positive AML.

Key Points: 
  • Expected to initiate in 2023, the collaboration will be a new cohort in ImmunoGen's 802 study and will evaluate pivekimab in combination with magrolimab in up to 42 patients with R/R CD123-positive AML.
  • Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies.
  • Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML.
  • The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020.

ImmunoGen Provides Update on Pivotal CADENZA Study of Pivekimab Sunirine in Frontline Blastic Plasmacytoid Dendritic Cell Neoplasm

Retrieved on: 
Wednesday, August 31, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, European Medicines Agency, Security (finance), COVID-19, EMA, Cancer, Malignancy, Associate, Toxicity, Blastic plasmacytoid dendritic cell neoplasm, AML, Leukemia, ImmunoGen, Skin, Senior, DNA, Department, Azacitidine, De novo, Acute myeloid leukemia, U.S. Securities and Exchange Commission, Lymphoma, Lymphatic system, MD, Control, IGN, CRH, Company, FDA, Breakthrough therapy, Population, IMGN, ADC, Bone marrow, PIN, H. Lee Moffitt Cancer Center & Research Institute, Patient, Vaccine, Pharmaceutical industry, Medical imaging, BPDCN

ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today provided an update on the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Key Points: 
  • ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today provided an update on the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • The CADENZA study is enrolling frontline BPDCN patients, including patients with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM).
  • In data from the first ten patients in the pivotal CADENZA frontline cohort, the Company observed:
    4 of 6 PCHM patients achieved CR/CRc/CRh.
  • Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies.

Menarini Group’s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer

Retrieved on: 
Friday, August 19, 2022
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There is a major unmet need in the treatment of advanced or metastatic ER+/HER2- breast cancer after resistance builds in the earlier lines of treatment, commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.

Key Points: 
  • There is a major unmet need in the treatment of advanced or metastatic ER+/HER2- breast cancer after resistance builds in the earlier lines of treatment, commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
  • The Phase 3 EMERALD study (NCT03778931) evaluated elacestrant compared to SOC endocrine monotherapy (investigators choice of either fulvestrant or an aromatase inhibitor) in ER+/HER2- advanced or metastatic breast cancer patients.
  • The study results were recently published online in the Journal of Clinical Oncology (JCO) on May 18, 2022.
  • The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc, who conducted and successfully completed the EMERALD study.

Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

Retrieved on: 
Thursday, August 11, 2022
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The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.

Key Points: 
  • The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.
  • "The FDA's acceptance of our NDA with Priority Review marks an important regulatory milestonefor our company," commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
  • Elacestrant is an investigational selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced or metastatic breast cancer.
  • The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients.

 Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

Retrieved on: 
Thursday, August 11, 2022
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The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.

Key Points: 
  • The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.
  • The FDAs acceptance of our NDA with Priority Review marks an important regulatory milestone for our company, commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group.
  • Elacestrant is an investigational selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once-daily oral treatment in patients with ER+/ HER2- advanced or metastatic breast cancer.
  • The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients.

LAVA Therapeutics Provides Business Update and Reports First Quarter Financial Results

Retrieved on: 
Tuesday, May 17, 2022
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We will continue to enroll patients in this dose escalation trial and announce initial data later this year.

Key Points: 
  • We will continue to enroll patients in this dose escalation trial and announce initial data later this year.
  • Ed Smith, chief financial officer of LAVA Therapeutics, has resigned to pursue other interests, effective as ofMay 17, 2022.
  • Research and development expenses were $7.6 million for the quarter ended March 31, 2022, compared to $18.7 million for the quarter ended March 31, 2021.
  • General and administrative expenses were $4.3 million for the quarter ended March 31, 2022, compared to $1.7 million for the quarter ended March 31, 2021.

Blastic Plasmacytoid Dendritic Cell Neoplasm Pipeline Research Report 2022 Featuring AbbVie, ImmunoGen, Mustang Bio, & Genentech - ResearchAndMarkets.com

Retrieved on: 
Friday, April 29, 2022
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The "Blastic Plasmacytoid Dendritic Cell Neoplasm - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Blastic Plasmacytoid Dendritic Cell Neoplasm - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
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  • The assessment part of the report embraces, in depth Blastic Plasmacytoid Dendritic cell neoplasm commercial assessment and clinical assessment of the pipeline products under development.
  • Companies and academics are working to assess challenges and seek opportunities that could influence Blastic Plasmacytoid Dendritic cell neoplasm R&D.