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Details:
Results demonstrate strong, but not universal, correlation between organ clinical responses and clinically meaningful improvements in patient-reported outcomes from a pooled analysis of ROCKstar and KD025-208 for Rezurock (belumosudil) clinical trials.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Rezurock
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 21, 2022
Iran Expo
Not Confirmed
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Details:
The acquisition supports Rezurock™(belumosudil) to its transplant portfolio. Rezurock is a FDA-approved, treatment for chronic graft-versus-host disease for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Rezurock
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $1,900.0 million Upfront Cash: $1,900.0 million
Deal Type: Acquisition September 08, 2021
Iran Expo
Not Confirmed
Contact SupplierDetails:
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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2021
Iran Expo
Not Confirmed
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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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Iran Expo
Not Confirmed
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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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor Fitzgerald & Co
Deal Size: $240.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 16, 2021
Iran Expo
Not Confirmed
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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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Iran Expo
Not Confirmed
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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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Iran Expo
Not Confirmed
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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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 05, 2020
Iran Expo
Not Confirmed
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Belumosudil achieved clinically meaningful and statistically significant Overall Response Rates of 73% with 200 mg once daily and 74% with 200 mg twice daily. Responses were achieved across key patient subgroups and complete responses were observed in all organ systems.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Iran Expo
Not Confirmed
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Based on the feedback from the FDA, the Company believes the proposed data package will be sufficient to support a submission of KD025 for the treatment of patients with cGVHD.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
KD025 has been well tolerated and has already demonstrated high response rates in patients with severe and complex cGVHD after a median of five months of follow-up.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
The extended data set will include response rates across core subgroups and initial ROCKstar safety data, which assesses KD025 in cGVHD in patients who have received at least two systematic therapies.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
The FDA’s approval of REZUROCK comes as a result of the Phase II KD025-213 clinical trial which demonstrated 75% overall response rate after six cycles of therapy at a dose of 200mg orally once daily in patients with chronic GVHD disease.
Lead Product(s): Belumosudil
Therapeutic Area: Immunology Product Name: Rezurock
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
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