Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 2 Results Show Rilzabrutinib Reduced Itch Severity in Chronic Spontaneous Urticaria
Details : PRN1008 (rilzabrutinib) is an oral, reversible covalent BTK inhibitor. It is being evaluated for the treatment of adults with moderate-to-severe chronic spontaneous urticaria.
Product Name : PRN1008
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 24, 2024
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 03, 2021
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Cantor Fitzgerald
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...
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 16, 2021
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Cantor Fitzgerald
Deal Size : $240.0 million
Deal Type : Public Offering
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Kadmon Announce FDA Acceptance of NDA for Belumosudil in Chronic Graft-Versus-Host Disease
Details : Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 30, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Kadmon Announces Acceptance of Late-Breaking Abstract of KD025 for cGVHD at the 2020 TCT Meetings
Details : 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.
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 01, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 30, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Principia Announces First Patient Dosed in Phase 2A Trial of Rilzabrutinib in IgG4-Related Disease
Details : The multicenter Phase 2A trial is anticipated to enroll approximately 25 patients with active IgG4-RD in two arms, rilzabrutinib with glucocorticoids or glucocorticoids only.
Product Name : PRN1008
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 17, 2020
Lead Product(s) : Rilzabrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 09, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Meiji Seika Pharma
Deal Size : Undisclosed
Deal Type : Collaboration
Meiji & Kadmon Enter into a Partnership to Develop & Commercialize KD025 for GVHD
Details : The collaboration aims to focus on the development and commercialization of KD025 (Belumosudil Mesylate) in Japan and other Asian countries. It is indicated for the treatment of Chronic GVHD.
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 01, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Meiji Seika Pharma
Deal Size : Undisclosed
Deal Type : Collaboration
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Rezurock
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 21, 2020
Lead Product(s) : Belumosudil
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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