Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Rezurock
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 21, 2022
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Sanofi
Deal Size : $1,900.0 million
Deal Type : Acquisition
Sanofi to Acquire Kadmon to Further Strengthen Growth of Transplant Business
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 sys...
Brand Name : Rezurock
Molecule Type : Small molecule
Upfront Cash : $1,900.0 million
September 08, 2021
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Sanofi
Deal Size : $1,900.0 million
Deal Type : Acquisition
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Kadmon Doses First Patient in Open-Label Phase 2 Clinical Trial of Belumosudil in Systemic Sclerosis
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).
Brand Name : KD025-209
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 01, 2021
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KD025
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 11, 2021
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Cantor Fitzgerald & Co
Deal Size : $240.0 million
Deal Type : Public Offering
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...
Brand Name : KD025
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 16, 2021
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Cantor Fitzgerald & Co
Deal Size : $240.0 million
Deal Type : Public Offering
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KD025
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 04, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : KD025
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Grants Orphan Drug Designation to Kadmon's Belumosudil for the Treatment of Systemic Sclerosis
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.
Brand Name : KD025
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 08, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Undisclosed
Deal Size : $50.0 million
Deal Type : Public Offering
Kadmon Raises $50 Million in Gross Proceeds Through Its at-the-Market Facility
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 05, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Undisclosed
Deal Size : $50.0 million
Deal Type : Public Offering
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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 al...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 21, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable