API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
Through the partnership, X4 Pharmaceuticals will distribute Xolremdi (mavorixafor), recently approved by the FDA. It is indicated for use in patients 12 years of age and older with warts, hypogammaglobulinemia, infections and myelokathexis syndrome.
Lead Product(s): Mavorixafor
Therapeutic Area: Genetic Disease Product Name: Xolremdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: X4 Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 29, 2024
Details:
Xolremdi (mavorixafor) is a selective CXC chemokine receptor 4 (CXCR4) antagonist, which is now approved for the treatment of WHIM syndrome in patients 12 years of age and older.
Lead Product(s): Mavorixafor
Therapeutic Area: Genetic Disease Product Name: Xolremdi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Details:
Mavorixafor is an investigational small-molecule antagonist of the CXCR4 receptor being developed as a once-daily oral therapy for WHIM syndrome and certain chronic neutropenic disorders.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2023
Details:
X4P-001 (mavorixafor) is an investigational small-molecule antagonist of CXCR4 being developed as a once-daily oral therapy to correct the dysfunction resulting from the underlying causes of WHIM.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2023
Details:
The financing will be used for the potential commercial launch of X4P-001 (mavorixafor) in individuals with WHIM syndrome and continue to advance mavorixafor for certain chronic neutropenic disorders.
Lead Product(s): Mavorixafor
Therapeutic Area: Rare Diseases and Disorders Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing August 03, 2023
Details:
X4 expects to use the proceedings for continued clinical development and commercial readiness of its lead candidate, X4P-001 (mavorixafor), an orally bioavailable CXCR4 antagonist.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $65.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement May 16, 2023
Details:
X4P-001 (mavorixafor) is an investigational small-molecule antagonist of CXCR4 being developed as a once-daily oral therapy to correct the dysfunction resulting from the underlying causes of WHIM.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2023
Details:
X4P-001 (mavorixafor) is a small molecule antagonist of chemokine receptor CXCR4. Due to mavorixafor’s ability to antagonize CXCR4 and improve the mobilization of WBC, mavorixafor has the potential to provide therapeutic benefit across a variety of immune system diseases.
Lead Product(s): Mavorixafor
Therapeutic Area: Rare Diseases and Disorders Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $65.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 07, 2022
Details:
X4P-001 (mavorixafor), a small molecule antagonist of chemokine receptor CXCR4 is being developed as an oral, once-daily therapy. Mavorixafor has the ability to antagonize CXCR4 and improve the mobilization of white blood cells.
Lead Product(s): Mavorixafor
Therapeutic Area: Rare Diseases and Disorders Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering December 06, 2022
Details:
Trial meets primary endpoint and first key secondary endpoint, with X4P-001 (mavorixafor) achieving statistically significant and clinically relevant longer times above threshold levels for both absolute neutrophil and absolute lymphocyte counts versus placebo.
Lead Product(s): Mavorixafor
Therapeutic Area: Genetic Disease Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2022
Details:
Results of the Phase 1b clinical trial suggested that X4P-001 (mavorixafor) could be the first oral treatment for CN disorders and has the potential to reduce or replace injectable G-CSF, the current standard of care.
Lead Product(s): Mavorixafor
Therapeutic Area: Hematology Product Name: X4P-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2022
Details:
X4 expects to use these funds for continued clinical development and commercial readiness of its lead candidate, X4P-001 (mavorixafor), and for business development activities, working capital, and general corporate purposes.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: New Enterprise Associates
Deal Size: $55.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement June 30, 2022
Details:
X4P-001(mavorixafor) is an oral, small molecule, CXCR4 antagonist currently being evaluated across three clinical studies: a fully enrolled Phase 3 trial in adults and adolescents with WHIM.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Clinical proof of concept for X4P-001 (mavorixafor) in a Phase 2 trial of WHIM syndrome demonstrated reduction in severe neutropenia and significant lymphopenia; overall, mavorixafor was well tolerated.
Lead Product(s): Mavorixafor,Ibrutinib
Therapeutic Area: Oncology Product Name: X4P-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Mavorixafor continues to show durable increases in neutrophils and lymphocytes, sustained improvements in infections and warts, and good tolerability in the ongoing Phase 2 open-label extension trial in WHIM syndrome.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
Mavorixafor, is a first-in-class, small molecule antagonist of chemokine receptor CXCR4 being developed as a once-daily oral therapy used in patients with WHIM syndrome, Waldenström’s macroglobulinemia, and Severe Congenital Neutropenia and other chronic neutropenia disorders.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The proceeds from this transaction are expected to be used by X4 for clinical development of its pipeline which includes its lead product, X4P-001, business development activities, working capital and general corporate purposes.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Abingworth
Deal Size: $55.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 19, 2021
Details:
Mavorixafor is currently being investigated in a global pivotal Phase 3 clinical trial, 4WHIM, for the treatment of WHIM syndrome in patients who are 12 years of age and older.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2020
Details:
Mavorixafor is a potential first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4, currently being investigated in a global pivotal Phase 3 clinical trial, 4WHIM, for the treatment of WHIM syndrome.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: X4P-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
X4 Pharmaceuticals expects to release initial data from a Phase Ib trial of mavorixafor for use in patients with Waldenstrom's macroglobulinemia in the first half of 2021.
Lead Product(s): Mavorixafor,Ibrutinib
Therapeutic Area: Oncology Product Name: X4P-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 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.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: AMD11070
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Data reveal reductions in annual infections and warts, and sustained dose-dependent increases in neutrophil counts.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
X4 is developing mavorixafor, a CXCR4 antagonist, that has demonstrated high selectivity for inhibiting CXCR4 signaling and restoring the trafficking of neutrophils and lymphocytes.
Lead Product(s): Mavorixafor
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2020