Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev®
Details : Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Brand Name : Recorlev
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 30, 2023
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Brand Name : Recorlev
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 01, 2022
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Brand Name : Recorlev
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 12, 2022
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Levoketoconazole (Recorlev) is an important and welcome new therapeutic option for clinicians to help manage patients with endogenous Cushing's syndrome, a severe, potentially life-threatening rare disease.
Brand Name : Recorlev
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 30, 2021
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Jefferies
Deal Size : Undisclosed
Deal Type : Public Offering
Strongbridge Biopharma plc Announces Proposed Public Offering of Ordinary Shares
Details : The Company intends to use the net proceeds to continue development and regulatory activities, facilitate commercial readiness and commercially launch Recorlev primarily in the US, support the life cycle management activities of Keveyis and for general c...
Brand Name : Recorlev
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 16, 2020
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Jefferies
Deal Size : Undisclosed
Deal Type : Public Offering
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoint...
Brand Name : Recorlev
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 01, 2020
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Avenue Venture Opportunities Fund
Deal Size : $30.0 million
Deal Type : Financing
Details : The fund obtained from the debt facility will help Strongbridge Biopharma to accelerate clinical development program for RECORLEV® (levoketoconazole) and the commercial progress and potential of KEVEYIS® (dichlorphenamide).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 20, 2020
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Avenue Venture Opportunities Fund
Deal Size : $30.0 million
Deal Type : Financing
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Strongbridge has completed enrollment in the Phase 3 LOGICS study for RECORLEV® (levoketoconazole), for the treatment of endogenous Cushing’s syndrome.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 11, 2020
Lead Product(s) : Levoketoconazole
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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