FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): KD033

            Therapeutic Area: Oncology Product Name: KD033

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

            Details:

            First patient has been dosed in a Phase 1 clinical trial evaluating KD033 in patients with metastatic or locally advanced solid tumors. KD033 is a novel immunotherapy designed to stimulate innate and adaptive immune responses directed to the tumor microenvironment.

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            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

            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.

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            Lead Product(s): Belumosudil

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 May 21, 2020

            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 all organ systems.

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            Lead Product(s): Belumosudil

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 14, 2020

            Details:

            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.

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            Lead Product(s): Belumosudil

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 February 23, 2020

            Details:

            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.

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            Lead Product(s): Belumosudil

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 January 10, 2020

            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.