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Details:
PRN1008 (rilzabrutinib) is an oral Bruton’s tyrosine kinase (BTK) inhibitor incorporating Sanofi’s TAILORED COVALENCY® technology being investigated for the treatment of immune-mediated diseases, including ITP.
Lead Product(s):
Rilzabrutinib
Therapeutic Area: Immunology
Product Name: PRN1008
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 10, 2022
Details:
Rilzabrutinib is an investigational oral Bruton tyrosine kinase inhibitor (BTKi) for the treatment of ITP, a rare acquired autoimmune disorder in which platelets are destroyed or damaged and for which there are limited treatment options.
Lead Product(s):
Rilzabrutinib
Therapeutic Area: Immunology
Product Name: PRN1008
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
April 14, 2022
Details:
In a Phase 3 trial in patients refractory to omalizumab, Dupixent did not reach statistical significance in an interim analysis despite numeric improvements observed across key endpoints; trial will be stopped due to futility.
Lead Product(s):
Dupilumab
Therapeutic Area: Immunology
Product Name: Dupixent
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Regeneron Pharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 18, 2022
Details:
Rilzabrutinib is a potential first-in-class, oral Bruton's tyrosine kinase (BTK) inhibitor in development for immune-mediated diseases. Rilzabrutinib’s safety profile remained consistent with previous results and no new safety signals were identified.
Lead Product(s):
Rilzabrutinib
Therapeutic Area: Immunology
Product Name: PRN1008
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 09, 2021
Details:
The CADENZA trial is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of sutimlimab in patients with CAD without a recent history of blood transfusion (within the past 6 months).
Lead Product(s):
Sutimlimab
Therapeutic Area: Immunology
Product Name: BIVV009
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Sanofi
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 11, 2021
Details:
Data from the pivotal Phase 3 CARDINAL study demonstrated sutimlimab inhibited C1-activated hemolysis (abnormal destruction of healthy red blood cells) within one week of treatment and had a sustained treatment effect over the course of the study.
Lead Product(s):
Sutimlimab
Therapeutic Area: Immunology
Product Name: BIVV009
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
April 07, 2021
Details:
PEGASUS is a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial enrolling approximately 120 participants to evaluate rilzabrutinib versus placebo, using a background treatment of tapering doses of corticosteroids (CS).
Lead Product(s):
Rilzabrutinib
Therapeutic Area: Immunology
Product Name: PRN1008
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 24, 2020
Details:
In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018.
Lead Product(s):
Rilzabrutinib
Therapeutic Area: Immunology
Product Name: PRN1008
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 18, 2020
Details:
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.
Lead Product(s):
Sutimlimab
Therapeutic Area: Immunology
Product Name: BIVV009
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 14, 2020
Details:
The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.
Lead Product(s):
Tolebrutinib
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
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