Phase III

Diamyd Medical AB

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SWEDEN Sweden

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Phase IIb Topline Results Demonstrate a Significant Treatment Effect of Diamyd® in Type 1 Diabetes

Lead Product(s): GAD-alum

Therapeutic Area: Endocrinology Product Name: Diamyd

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 September 14, 2020

Details:

In line with previous large-scale analysis of trials involving subcutaneous administration of Diamyd®, the reults, encompassing a total of 109 patients, showed a statistically significant effect in the predefined HLA (Human Leukocyte Antigen) subgroup of trial participants.

Ascendis Pharma

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DENMARK Denmark

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Ascendis Pharma A/S Submits Marketing Authorisation Application to the EMA for TransCon™ hGH for Pediatric Growth Hormone Deficiency

Lead Product(s): TransCon hGH

Therapeutic Area: Endocrinology Product Name: ACP-001

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 08, 2020

Details:

This MAA submission, which follows the approval of our Paediatric Investigation Plan (PIP) from EMA, is an important next step for extending the global reach of TransCon hGH.

Diamyd Medical AB

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SWEDEN Sweden

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Diamyd Medical's Analysis of Prevention Trials and Intralymphatic Pilot Trial with the Diabetes Vaccine Diamyd® Support a Positive Trend in...

Lead Product(s): GAD-alum

Therapeutic Area: Endocrinology Product Name: Diamyd

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 September 01, 2020

Details:

The analysis while not reaching statistical significance, supports a positive effect of subcutaneous injections of Diamyd® on delaying the progression to type 1 diabetes in HLA-type DR3-DQ2 group while no benefit vs placebo is seen in individuals negative for HLA-type DR3-DQ2.

Lipocine

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United States

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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.

Ascendis Pharma

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DENMARK Denmark

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Ascendis Pharma Announces New Data from the Four-Week, Fixed Dose, Double-Blind Portion of the PaTH Forward Trial

Lead Product(s): TransCon hGH

Therapeutic Area: Endocrinology Product Name: ACP-001

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2020

Details:

New data from the four-week, fixed dose, double-blind portion of PaTH Forward demonstrated statistically significant and clinically meaningful improvements in SF-36 functional health and well being outcomes.

Hua Medicine

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CHINA China

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Bayer and Hua Medicine Announce Commercialization Agreement

Lead Product(s): Dorzagliatin

Therapeutic Area: Endocrinology Product Name: HMS5552

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Bayer HealthCare

Deal Size: $635.8 million Upfront Cash: $43.3 milllion

Deal Type: Agreement August 17, 2020

Details:

Hua Medicine shall be responsible for clinical development, registration, product supply and distribution of dorzagliatin, whilst Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China.

Diamyd Medical AB

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SWEDEN Sweden

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Diabetologia Publishes Results Highlighting Efficacy of the Diabetes Vaccine Diamyd® in Genetically Defined Subgroups of Type 1 Diabetes

Lead Product(s): GAD-alum

Therapeutic Area: Endocrinology Product Name: Diamyd

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 August 05, 2020

Details:

Diabetologia published results from a meta study that demonstrates a highly significant and clinically relevant effect of Diamyd Medical's lead drug candidate Diamyd® on preserving endogenous insulin production in genetically defined subgroups of type 1 diabetes.

Poxel

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FRANCE France

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Poxel Announces Submission of Imeglimin Japanese New Drug Application for the Treatment of Type 2 Diabetes by Sumitomo Dainippon Pharma

Lead Product(s): Imeglimin

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Sumitomo Dainippon Pharma Co., Ltd

Deal Size: $21.3 million Upfront Cash: Undisclosed

Deal Type: Agreement July 30, 2020

Details:

Sumitomo Dainippon Pharma has submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.

Corcept Therapeutics

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United States

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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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United States

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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.

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Companies

Diamyd Medical AB

Phase IIb Topline Results Demonstrate a Significant Treatment Effect of Diamyd® in Type 1 Diabetes

Ascendis Pharma

Ascendis Pharma A/S Submits Marketing Authorisation Application to the EMA for TransCon™ hGH for Pediatric Growth Hormone Deficiency

Diamyd Medical AB

Diamyd Medical's Analysis of Prevention Trials and Intralymphatic Pilot Trial with the Diabetes Vaccine Diamyd® Support a Positive Trend in...

Lipocine

Lipocine Provides Regulatory Update for TLANDO™

Ascendis Pharma

Ascendis Pharma Announces New Data from the Four-Week, Fixed Dose, Double-Blind Portion of the PaTH Forward Trial

Hua Medicine

Bayer and Hua Medicine Announce Commercialization Agreement

Diamyd Medical AB

Diabetologia Publishes Results Highlighting Efficacy of the Diabetes Vaccine Diamyd® in Genetically Defined Subgroups of Type 1 Diabetes

Poxel

Poxel Announces Submission of Imeglimin Japanese New Drug Application for the Treatment of Type 2 Diabetes by Sumitomo Dainippon Pharma

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