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            Lead Product(s): Testosterone Undecanoate

            Therapeutic Area: Endocrinology Product Name: Tlando

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 28, 2020

            Details:

            U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO’s New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.

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            Lead Product(s): Relacorilant

            Therapeutic Area: Endocrinology Product Name: CORT125134

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 28, 2020

            Details:

            GRADIENT is a double-blind, placebo-controlled Phase 3 trial, with a planned enrollment of 130 patients at sites in the United States and Europe. Half of the patients will receive relacorilant and the other half placebo for six months.

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            Lead Product(s): Sotagliflozin

            Therapeutic Area: Endocrinology Product Name: Zynquista

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 21, 2020

            Details:

            The observed safety profile of sotagliflozin in these studies was generally consistent with that of approved SGLT2 inhibitors.

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            Lead Product(s): Levoketoconazole

            Therapeutic Area: Endocrinology Product Name: Recorlev

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 01, 2020

            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 endpoints.

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: PRV-031

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: SVB Leerink

            Deal Size: $95.7 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 17, 2020

            Details:

            Provention Bio intends to use its net proceeds from the public offering for funding of the clinical development of PRV-031, development activities for PRV-015, development activities for PRV-3279 and PRV-101.

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            Lead Product(s): Teplizumab

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Provention Bio announced extended follow-up data showing a single 14-day course of teplizumab (PRV-031) significantly delayed the onset of insulin-dependent type 1 diabetes (T1D) in presymptomatic patients by a median of approximately three years compared to placebo.

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            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2020

            Details:

            Company's Japan Phase 3 clinical trial met its primary and secondary objectives, and demonstrated the efficacy and safety of somatrogon administered weekly was comparable to GENOTROPIN® (somatropin) in treatment-naïve Japanese pre-pubertal children with GHD.

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            Lead Product(s): Tirzepatide

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2020

            Details:

            The study will assess both non-inferiority and superiority of tirzepatide in a head-to-head trial against Trulicity® (dulaglutide) 1.5 mg – the market leading GLP-1 receptor agonist.

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            Lead Product(s): Levoketoconazole

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Avenue Venture Opportunities Fund

            Deal Size: $30.0 million Upfront Cash: Undisclosed

            Deal Type: Debt Facility May 20, 2020

            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).

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            Lead Product(s): Levoketoconazole

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2020

            Details:

            Strongbridge has completed enrollment in the Phase 3 LOGICS study for RECORLEV® (levoketoconazole), for the treatment of endogenous Cushing’s syndrome.

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