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Lipocine

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Lipocine Provides Regulatory Update for TLANDO™

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.

Corcept Therapeutics

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Corcept Therapeutics Initiates Phase 3 Trial of Relacorilant in Patients with Cushing’s Syndrome of Adrenal Origin

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.

Lexicon pharmaceuticals

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Lexicon Pharmaceuticals Announces Topline Phase 3 Data From Four Phase 3 Sotagliflozin Studies In Type 2 Diabetes

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.

Strongbridge Biopharma

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Strongbridge Biopharma plc Announces Last Patient Completes Last Study Visit in the Randomized Withdrawal Phase of the LOGICS Trial Evaluati...

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.

Provention Bio

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Provention Bio Announces Pricing of $95.7 Million Public Offering of Common Stock

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.

Provention Bio

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Provention Bio's Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients

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.

OPKO Healthcare

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OPKO Health Announces Top-Line Results of Phase 3 Efficacy and Safety Study of Somatrogon for the Treatment of Growth Hormone Deficiency

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.

Eli Lilly

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Lilly Starts Large-Scale Trial of Tirzepatide In Diabetic Heart Disease

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.

Strongbridge Biopharma

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Strongbridge Biopharma plc Announces $30 Million Debt Facility with Avenue Venture Opportunities Fund, L.P.

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).

Strongbridge Biopharma

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Strongbridge Biopharma plc Announces Completion of Enrollment of Phase 3 LOGICS Study for RECORLEV for Endogenous Cushing’s Syndrome

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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Companies

Lipocine

Lipocine Provides Regulatory Update for TLANDO™

Corcept Therapeutics

Corcept Therapeutics Initiates Phase 3 Trial of Relacorilant in Patients with Cushing’s Syndrome of Adrenal Origin

Lexicon pharmaceuticals

Lexicon Pharmaceuticals Announces Topline Phase 3 Data From Four Phase 3 Sotagliflozin Studies In Type 2 Diabetes

Strongbridge Biopharma

Strongbridge Biopharma plc Announces Last Patient Completes Last Study Visit in the Randomized Withdrawal Phase of the LOGICS Trial Evaluati...

Provention Bio

Provention Bio Announces Pricing of $95.7 Million Public Offering of Common Stock

Provention Bio

Provention Bio's Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients

OPKO Healthcare

OPKO Health Announces Top-Line Results of Phase 3 Efficacy and Safety Study of Somatrogon for the Treatment of Growth Hormone Deficiency

Eli Lilly

Lilly Starts Large-Scale Trial of Tirzepatide In Diabetic Heart Disease

Strongbridge Biopharma

Strongbridge Biopharma plc Announces $30 Million Debt Facility with Avenue Venture Opportunities Fund, L.P.

Strongbridge Biopharma

Strongbridge Biopharma plc Announces Completion of Enrollment of Phase 3 LOGICS Study for RECORLEV for Endogenous Cushing’s Syndrome