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Lead Product(s): Iodine-131 apamistamab
Therapeutic Area: Hematology Product Name: Iomab-B
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Memorial Sloan Kettering Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
Apamistamab CD45 antibody is the basis for lead Phase 3 candidate Iomab-B for targeting conditioning prior to bone marrow transplant and next generation Iomab-ACT targeted conditioning program for CAR-T and Gene Therapies.
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Lead Product(s): Narsoplimab
Therapeutic Area: Hematology Product Name: OMS721
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
Details:
Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.
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Lead Product(s): Fostamatinib Disodium
Therapeutic Area: Hematology Product Name: Tavalisse
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
Rigel received approval from the FDA for its Phase 3 clinical trial of fostamatinib disodium hexahydrate in warm autoimmune hemolytic anemia, to include proposed durable response measure for the primary efficacy endpoint and inclusion of additional secondary endpoints.
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Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Highlights include new analyses from the Phase 3 head-to-head PEGASUS study, which demonstrate a markedly greater proportion of patients achieved better hematological responses as well as quality-of-life improvements with pegcetacoplan versus eculizumab, a C5 inhibitor.
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Lead Product(s): Narsoplimab
Therapeutic Area: Hematology Product Name: OMS721
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway and activator of the coagulation cascade, is being studied for the treatment of HSCT-TMA patients at high risk for poor outcomes.
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Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined.
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Lead Product(s): Narsoplimab
Therapeutic Area: Hematology Product Name: OMS721
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
These updated data and analyses form the basis of regulatory review and product labeling. The BLA also includes data from the HSCT-TMA compassionate-use program, which are highly consistent with the clinical trial data.
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Lead Product(s): Bentracimab
Therapeutic Area: Hematology Product Name: PB2452
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
PhaseBio has expanded its pivotal Phase 3 REVERSE-IT trial for its lead product candidate bentracimab (formerly PB2452) into Canada, where the first patients outside of the United States have now been enrolled and dosed.
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Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
The NDA and MAA submissions are based on results from the Phase 3 PEGASUS study, which met its primary endpoint, demonstrating the superiority of pegcetacoplan to eculizumab with a statistically significant improvement in hemoglobin levels at 16 weeks.
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Lead Product(s): Pegcetacoplan
Therapeutic Area: Hematology Product Name: APL-2
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
The study was designed to evaluate the efficacy of pegcetacoplan in 48 adult patients who are treatment-naïve, showed evidence of hemolysis (elevated LDH ≥ 1.5x ULN) and had hemoglobin levels that were less than the lower limit of normal at the time of their screening.
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