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Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AbbVie's Upadacitinib (RINVOQ\u00ae) Met Primary and Most Ranked Secondary Endpoints in Phase 3 Study for Non-Radiographic Axial Spondyloarthritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AbbVie Inc"},{"company":"AbbVie Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AbbVie's RINVOQ\u00ae (Upadacitinib) Met Primary and All Ranked Secondary Endpoints in Phase 3 Study in Ankylosing Spondylitis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small 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Details:
RINVOQ® (upadacitinib) is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. SELECT-AXIS 2 is the first trial to evaluate efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.
Lead Product(s):
Upadacitinib
Therapeutic Area: Immunology
Product Name: Rinvoq
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
October 07, 2021
Details:
RINVOQ® (upadacitinib) is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. SELECT-AXIS 2 is the first trial to evaluate efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.
Lead Product(s):
Upadacitinib
Therapeutic Area: Immunology
Product Name: Rinvoq
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
October 07, 2021
Details:
The Phase 2 study (KD025-215) will enroll up to 15 adults with dcSSc who will receive orally administered belumosudil 200 mg twice daily (BID). Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2).
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: KD025-209
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
April 01, 2021
Details:
In a notice received from the FDA on March 9, 2021, the Company was informed that the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of belumosudil has been extended to August, 2021.
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: KD025
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
March 11, 2021
Details:
Kadmon plans to use a part of the proceeds to prepare to commercialize belumosudil for chronic graft-vs-host disease in the U.S; for its clinical-stage product candidates; for discovery and preclinical studies of other product candidates; and for general corporate purposes.
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: KD025
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Cantor Fitzgerald & Co
Deal Size: $240.0 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
February 16, 2021
Details:
The presentation will include 12-month efficacy and safety data and key secondary endpoints including duration of response, Failure-Free Survival, steroid dose reductions and quality-of-life improvements.
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: KD025
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
November 04, 2020
Details:
The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD who failed two or more lines of systemic therapy.
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: KD025
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
September 30, 2020
Details:
Belumosudil is being studied in an ongoing double-blind, placebo-controlled Phase 2 clinical trial in adults with SSc. The study is enrolling 60 patients to receive belumosudil 200 mg QD, belumosudil 200 mg BID or placebo for 24 weeks.
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: KD025
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
September 08, 2020
Details:
Data show the clinical activity of ABBV-3373 and support advancing the development of the platform in rheumatoid arthritis and initiating clinical studies in other immune-mediated diseases.
Lead Product(s):
ABBV-3373
Therapeutic Area: Immunology
Product Name: Undisclosed
Highest Development Status: Phase II
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 10, 2020
Details:
The proceeds from the offering will be used to advance belumosudil toward a NDA filing with the U.S FDA and support related pre-commercialization activities and provide additional working capital for general corporate purposes.
Lead Product(s):
Belumosudil
Therapeutic Area: Immunology
Product Name: Undisclosed
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Undisclosed
Deal Size: $50.0 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
June 05, 2020
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