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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.

OPKO Healthcare

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OPKO Health to Present Somatrogon Phase 3 Pediatric Trial Results at ENDO Online 2020

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 April 22, 2020

Details:

OPKO Health to present data from its pivotal Phase 3 study and interpretation of IGF-1 levels following administration of Somatrogon.

Lipocine

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U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition

Lead Product(s): Testosterone Undecanoate

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 April 17, 2020

Details:

Clarus originally filed the Citizens Petition with the FDA requesting the FDA issue "clear, written guidance regarding the safety and efficacy standards for oral testosterone-ester prodrugs.

Provention Bio

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Provention Bio Initiates Rolling Submission of Biologic License Application for Teplizumab

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 April 16, 2020

Details:

The data from the 'At Risk' Study, published last year, underscores the transformative therapeutic potential of teplizumab to delay or prevent the onset of clinical-stage, insulin-dependent, T1D.

Provention Bio

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Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes

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 March 16, 2020

Details:

PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis

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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

OPKO Healthcare

OPKO Health to Present Somatrogon Phase 3 Pediatric Trial Results at ENDO Online 2020

Lipocine

U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition

Provention Bio

Provention Bio Initiates Rolling Submission of Biologic License Application for Teplizumab

Provention Bio

Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes