Find Immunology Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Mavorixafor

            Therapeutic Area: Immunology Product Name: AMD11070

            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 September 02, 2020

            Details:

            Publication infoms about a comprehensive safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy data of mavorixafor from an ongoing Phase 2, dose-escalation study in adult patients with genetically confirmed WHIM syndrome.

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            Lead Product(s): Upadacitinib

            Therapeutic Area: Immunology Product Name: Rinvoq

            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 August 25, 2020

            Details:

            The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.

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            Lead Product(s): Nipocalimab

            Therapeutic Area: Immunology Product Name: M281

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Johnson & Johnson

            Deal Size: $6,500.0 million Upfront Cash: $6,500.0 million

            Deal Type: Acquisition August 19, 2020

            Details:

            This acquisition gives Johnson & Johnson a major entry point into a new class of drugs. Momenta’s FcRn inhibitor, nipocalimab, has the potential to transform treatment of autoantibody-driven autoimmune diseases.

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            Lead Product(s): Filgotinib

            Therapeutic Area: Immunology Product Name: GS-6034

            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 August 18, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).

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            Lead Product(s): SAR442168

            Therapeutic Area: Immunology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $3,680.0 million Upfront Cash: $3,680

            Deal Type: Acquisition August 17, 2020

            Details:

            The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.

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            Lead Product(s): Filgotinib

            Therapeutic Area: Immunology Product Name: Jyseleca

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Galapagos

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 24, 2020

            Details:

            The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib.

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            Lead Product(s): Ruxolitinib

            Therapeutic Area: Immunology Product Name: Jakafi

            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 July 23, 2020

            Details:

            Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to best available therapy.

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            Lead Product(s): FCR001

            Therapeutic Area: Immunology Product Name: FCR001

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 22, 2020

            Details:

            The trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.

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            Lead Product(s): Avacopan,Rituximab,Cyclophosphamide

            Therapeutic Area: Immunology Product Name: CCX168

            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 July 09, 2020

            Details:

            The Company’s NDA submission is supported by the results of its pivotal Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.

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            Lead Product(s): Ustekinumab

            Therapeutic Area: Immunology Product Name: Stelara

            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 26, 2020

            Details:

            The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified.

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