Hematology | Phase III Developments | UNITED STATES

Apellis Pharmaceuticals

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Chinaplas 2020

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Apellis Completes Enrollment in Phase 3 Study of Pegcetacoplan in Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

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.

Apellis Pharmaceuticals

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Chinaplas 2020

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New Pivotal Data Demonstrate Superiority of Apellis’ Pegcetacoplan to Eculizumab in Improving Hemoglobin Levels

Lead Product(s): Pegcetacoplan

Therapeutic Area: Hematology Product Name: Undisclosed

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 June 12, 2020

Details:

71% of pegcetacoplan-treated patients achieved LDH normalization vs. 15% of eculizumab-treated patients. Detailed results from positive head-to-head Phase 3 PEGASUS study in patients with paroxysmal nocturnal hemoglobinuria presented at the European Hematology Association.

Rigel Pharmaceuticals

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Chinaplas 2020

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Rigel to Present Poster Highlighting TAVALISSE at the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress

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 June 11, 2020

Details:

In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% achieved ≥1 platelet count of ≥50,000/µL. Adverse events were manageable and consistent with those previously reported with fostamatinib.

Omeros

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Chinaplas 2020

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Omeros’ Narsoplimab Pivotal Trial Data to be Shared as an Oral Presentation at Annual European Hematology Association Congress

Lead Product(s): Narsoplimab

Therapeutic Area: Hematology Product Name: Undisclosed

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 June 11, 2020

Details:

The results of Omeros’ pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy will be shared as an oral presentation at the virtual edition of the 25th annual European Hematology Association Congress.

FibroGen, Inc

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Chinaplas 2020

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FibroGen Announces New Roxadustat Data Presented at 2020 ERA-EDTA Virtual Congress

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Undisclosed

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 June 08, 2020

Details:

Roxadustat demonstrates non-inferiority to darbepoetin alfa in achievement of Hb correction in DOLOMITES Phase 3 study of anemia in non-dialysis dependent patients with chronic kidney disease.

Apellis Pharmaceuticals

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Chinaplas 2020

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Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Lead Product(s): Pegcetacoplan

Therapeutic Area: Hematology Product Name: Undisclosed

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 May 21, 2020

Details:

The NDA submission is backed by results from Apellis Phase 3 PEGASUS study. Based on feedback from the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting to discuss the registration strategy for pegcetacoplan.

Akebia Therapeutics

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Chinaplas 2020

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Japan Tobacco Files Supplemental New Drug Application for Use of Riona to Treat Adult Patients with Iron Deficiency Anemia in Japan

Lead Product(s): Ferric Citrate

Therapeutic Area: Hematology Product Name: Undisclosed

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 May 18, 2020

Details:

The NDA is based on JT and Torii's Phase 3 clinical study and other clinical studies in adult patients with IDA in Japan.

Omeros

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Omeros Corporation Announces Presentation of Narsoplimab Pivotal Trial Data at Upcoming European Hematology Association Annual Congress

Lead Product(s): Narsoplimab

Therapeutic Area: Hematology Product Name: Undisclosed

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 May 14, 2020

Details:

The presentation will highlight Omeros's study entitled, Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy.

Akebia Therapeutics

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Chinaplas 2020

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Akebia Announced Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia in Adult Patients on Dialysis

Lead Product(s): Vadadustat

Therapeutic Area: Hematology Product Name: Undisclosed

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 May 05, 2020

Details:

In both of the two INNO2VATE trials, Vadadustat achieved primary and secondary efficacy endpoints. The cardiovascular outcomes program INNO2VATE, Phase 3 evaluates the efficacy & safety of vadadustat.

BeyondSpring

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Chinaplas 2020

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BeyondSpring Initiates New Drug Application Rolling Submission for Plinabulin in China for Chemotherapy-Induced Neutropenia

Lead Product(s): Plinabulin

Therapeutic Area: Hematology Product Name: Undisclosed

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 March 30, 2020

Details:

If approved, Plinabulin in combination with G-CSFs can potentially be the first superior therapy to the standard of care (G-CSF alone) for chemotherapy-induced neutropenia.

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Apellis Pharmaceuticals

Apellis Completes Enrollment in Phase 3 Study of Pegcetacoplan in Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Apellis Pharmaceuticals

New Pivotal Data Demonstrate Superiority of Apellis’ Pegcetacoplan to Eculizumab in Improving Hemoglobin Levels

Rigel Pharmaceuticals

Rigel to Present Poster Highlighting TAVALISSE at the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress

Omeros

Omeros’ Narsoplimab Pivotal Trial Data to be Shared as an Oral Presentation at Annual European Hematology Association Congress

FibroGen, Inc

FibroGen Announces New Roxadustat Data Presented at 2020 ERA-EDTA Virtual Congress

Apellis Pharmaceuticals

Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Akebia Therapeutics

Japan Tobacco Files Supplemental New Drug Application for Use of Riona to Treat Adult Patients with Iron Deficiency Anemia in Japan

Omeros

Omeros Corporation Announces Presentation of Narsoplimab Pivotal Trial Data at Upcoming European Hematology Association Annual Congress

Akebia Therapeutics

Akebia Announced Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia in Adult Patients on Dialysis

BeyondSpring

BeyondSpring Initiates New Drug Application Rolling Submission for Plinabulin in China for Chemotherapy-Induced Neutropenia