Hematology

Pfizer Inc

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United States

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FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)

Lead Product(s): Pegfilgrastim

Therapeutic Area: Hematology Product Name: Nyvepria

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

Lonza Group

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Switzerland

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Lonza Partners with Anthos Therapeutics for Thrombosis Treatment

Lead Product(s): Abelacimab

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Undisclosed Product Type: Large molecule

Partner/Sponsor/Collaborator: Anthos Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership June 11, 2020

Details:

The agreement furthers Anthos Therapeutics mission to develop Abelacimab for patients at risk of thrombotic events, which are currently underserved by conventional anti-coagulant therapies.

Akebia Therapeutics

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United States

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Akebia Announces Top-Line Results from its PRO2TECT Global Phase 3 Program of Vadadustat for Treatment of Anemia in CKD Patients

Lead Product(s): Vadadustat

Therapeutic Area: Hematology Product Name: Vafseo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 03, 2020

Details:

The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.

Omeros

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Omeros’ Investigational New Drug Application for OMS906 Cleared by FDA

Lead Product(s): OMS906

Therapeutic Area: Hematology Product Name: OMS906

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2020

Details:

OMS906 is the company’s lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system’s alternative pathway.

BioCryst Pharmaceuticals

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FDA Grants Orphan Drug Designation for BCX9930 in PNH

Lead Product(s): BCX9930

Therapeutic Area: Hematology Product Name: BCX9930

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2020

Details:

BioCryst Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Novartis Pharmaceuticals Corporation

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Switzerland

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Novartis announces positive results from Phase II study of LNP023 in patients with paroxysmal nocturnal hemoglobinuria (PNH)

Lead Product(s): LNP023

Therapeutic Area: Hematology Product Name: LNP023

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 29, 2020

Details:

Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis.

Pluristem Therapeutics

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ISRAEL Israel

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Pluristem Announces End of Patient Enrollment in its Phase I Hematology Study

Lead Product(s): PLX-R18

Therapeutic Area: Hematology Product Name: PLX-R18

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2020

Details:

The Phase I multi-center, open-label, 3 cohort dose-escalating study is evaluating the safety of intramuscular (IM) injections of PLX-R18 cells in 20 subjects, with incomplete hematopoietic recovery persisting for at least 3 months after HCT.

ARCA Biopharma

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United Kingdom

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ARCA Biopharma Announces Completion of FDA Pre-IND Consultation Under Coronavirus Treatment Acceleration Program for AB201

Lead Product(s): rNAPc2

Therapeutic Area: Hematology Product Name: AB201

Highest Development Status: Preclinical Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 12, 2020

Details:

The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19.

BioCryst Pharmaceuticals

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United States

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FDA Grants Fast Track Designation for BCX9930 in PNH

Lead Product(s): BCX9930

Therapeutic Area: Hematology Product Name: BCX9930

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

AMAG Pharmaceuticals

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AMAG Pharmaceuticals and Norgine B.V. Ink Exclusive Licensing Agreement to Commercialize Ciraparantag in Europe, Australia and New Zealand

Lead Product(s): Ciraparantag

Therapeutic Area: Hematology Product Name: PER977

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Norgine

Deal Size: $290.0 million Upfront Cash: $30.0 million

Deal Type: Licensing Agreement July 23, 2020

Details:

Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery or due to life-threatening or uncontrolled bleeding.

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Find Hematology Clinical Drug Pipeline Developments & Deals

Product Type

Development Status

Pfizer Inc

FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)

Lonza Group

Lonza Partners with Anthos Therapeutics for Thrombosis Treatment

Akebia Therapeutics

Akebia Announces Top-Line Results from its PRO2TECT Global Phase 3 Program of Vadadustat for Treatment of Anemia in CKD Patients

Omeros

Omeros’ Investigational New Drug Application for OMS906 Cleared by FDA

BioCryst Pharmaceuticals

FDA Grants Orphan Drug Designation for BCX9930 in PNH

Novartis Pharmaceuticals Corporation

Novartis announces positive results from Phase II study of LNP023 in patients with paroxysmal nocturnal hemoglobinuria (PNH)

Pluristem Therapeutics

Pluristem Announces End of Patient Enrollment in its Phase I Hematology Study

ARCA Biopharma

ARCA Biopharma Announces Completion of FDA Pre-IND Consultation Under Coronavirus Treatment Acceleration Program for AB201

BioCryst Pharmaceuticals

FDA Grants Fast Track Designation for BCX9930 in PNH

AMAG Pharmaceuticals

AMAG Pharmaceuticals and Norgine B.V. Ink Exclusive Licensing Agreement to Commercialize Ciraparantag in Europe, Australia and New Zealand