Phase III

Ascendis Pharma

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DENMARK Denmark

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Ascendis Pharma A/S Announces Submission of Biologics License Application for TransCon™ hGH in Pediatric Growth Hormone Deficiency

Lead Product(s): Lonapegsomatropin

Therapeutic Area: Endocrinology Product Name: TransCon hGH

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 26, 2020

Details:

TransCon hGH is designed to maintain the same mode of action as daily hGH therapies by releasing the same growth hormone molecule, somatropin.

Resverlogix Corp

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CANADA Canada

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Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study

Lead Product(s): Apabetalone,Atorvastatin

Therapeutic Area: Endocrinology Product Name: RVX000222

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 June 22, 2020

Details:

The FDA has accepted Resverlogix BETonMACE2 clinical plan as a registration enabling study with positive implications for Resverlogix and its ongoing partnership discussions.

Provention Bio

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United States

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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.

Zealand Pharma

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DENMARK Denmark

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Zealand Pharma Presents Clinical and Non-Clinical Evidence for Dasiglucagon Rescue Therapy

Lead Product(s): Dasiglucagon

Therapeutic Area: Endocrinology Product Name: HypoPal

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 14, 2020

Details:

The dasiglucagon HypoPal® rescue pen is under FDA review as a potential fast and effective treatment of severe hypoglycemia in diabetes.

Resverlogix Corp

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CANADA Canada

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Resverlogix Announces Key BETonMACE Renal Data from Plenary Session Presentation at ERA-EDTA Virtual Congress

Lead Product(s): Apabetalone,Atorvastatin

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 June 09, 2020

Details:

For the first time in patients with a recent Acute Coronary Syndrome with diabetes and stage 3 CKD co-morbidities, we observed a 50% reduction of MACE by a medication, apabetalone treatment.

OPKO Healthcare

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United States

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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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United States

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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.

Ascendis Pharma

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DENMARK Denmark

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Ascendis Pharma A/S Announces Participation in ENDO Online 2020

Lead Product(s): Lonapegsomatropin

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 08, 2020

Details:

The fliGHt Trial data presented at ENDO Online demonstrate that subjects taking daily somatropin can safely switch to TransCon hGH, an investigational long-acting prodrug that releases somatropin, with consistent and predictable efficacy.

Zealand Pharma

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DENMARK Denmark

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Zealand Pharma Announces FDA Acceptance of NDA for the Dasiglucagon Hypopal rescue Pen for Treatment of Severe Hypoglycemia

Lead Product(s): Dasiglucagon

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 May 22, 2020

Details:

The dasiglucagon HypoPal® rescue pen New Drug Application represents a major milestone in Zealand Pharma’s efforts to bring life changing therapies to people with diabetes.

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Companies

Ascendis Pharma

Ascendis Pharma A/S Announces Submission of Biologics License Application for TransCon™ hGH in Pediatric Growth Hormone Deficiency

Resverlogix Corp

Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study

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

Zealand Pharma

Zealand Pharma Presents Clinical and Non-Clinical Evidence for Dasiglucagon Rescue Therapy

Resverlogix Corp

Resverlogix Announces Key BETonMACE Renal Data from Plenary Session Presentation at ERA-EDTA Virtual Congress

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

Ascendis Pharma

Ascendis Pharma A/S Announces Participation in ENDO Online 2020

Zealand Pharma

Zealand Pharma Announces FDA Acceptance of NDA for the Dasiglucagon Hypopal rescue Pen for Treatment of Severe Hypoglycemia