Endocrinology | Phase II Developments

Poxel

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FRANCE France

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Poxel Successfully Raises €17.7 Million in a Capital Increase

Lead Product(s): PXL770

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: JMP Securities LLC

Deal Size: $19.4 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 25, 2020

Details:

The use of proceeds will enable the Company to accelerate the development plans for PXL770 and PXL065 for the treatment of NASH, to pursue development activities in other metabolic diseases and for general corporate purposes.

Xeris Pharmaceuticals

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Xeris Shares Findings From the Outpatient Portion of a Phase 2 Proof-of-Concept Study of Its Developmental Ready-to-Use (RTU) Glucagon

Lead Product(s): Glucagon

Therapeutic Area: Endocrinology

Highest Development Status: Phase II 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:

Rebound hypoglycemia observed in the placebo arm with oral glucose tablet use; No rebound hypoglycemia observed in the RTU glucagon treatment arm.

Creapharm

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FRANCE France

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AzurRx BioPharma Enters into Packaging, Labeling and Distribution Agreement with Creapharm Clinical Supplies for MS1819 Trial Drug Product

Lead Product(s): MS1819,Porcine enzyme replacement therapy

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: AzurRx BioPharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 07, 2020

Details:

Creapharm will package, label, and distribute AzurRx’s MS1819 clinical trial drug product for both the upcoming Phase 2b OPTION 2 Monotherapy and the ongoing Phase 2 Combination Therapy Programs.

Oramed Pharmaceuticals

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Oramed Pharmaceuticals to Present at the 80th American Diabetes Association Scientific Session, to be Held Virtually This Year in June

Lead Product(s): Insulin

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 06, 2020

Details:

The presentations will focus on Oramed's oral insulin candidate, ORMD-0801 and its impact on type-2 diabetes mellitus, as well as its impact on fatty liver in nonalcoholic steatohepatitis (NASH).

Ascendis Pharma

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DENMARK Denmark

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Ascendis Pharma A/S Announces Top-line Data from Fixed Dose Portion of Phase 2 Trial Demonstrating Potential of TransCon™ PTH

Lead Product(s): TransCon PTH

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 20, 2020

Details:

PaTH Forward trial met key objectives and showed that TransCon PTH eliminated standard of care in 82 percent of subjects within four weeks.

Delpharm Group

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FRANCE France

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AzurRx Announces Manufacturing Agreement with Delpharm for MS1819 Clinical Drug Product

Lead Product(s): MS1819

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: AzurRx BioPharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 16, 2020

Details:

Under this agreement, Delpharm will manufacture AzurRx’s MS1819 cGMP batch that will be used in the Phase 2b OPTION 2 Clinical Trial for the treatment of EPI in patients with Cystic Fibrosis.

Crinetics Pharmaceuticals

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United States

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Crinetics Pharmaceuticals Announces Proposed Public Offering of Common Stock

Lead Product(s): Paltusotine

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: SVB Leerink

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering April 14, 2020

Details:

Crinetics intends to use the net proceeds to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

Crinetics Pharmaceuticals

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Crinetics Pharmaceuticals Reports Positive Interim Results for the ACROBAT Edge Phase 2 Trial of Paltusotine

Lead Product(s): Paltusotine

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2020

Details:

Data from patients who have completed the ongoing open label Edge trial show that IGF-1 levels were maintained after 13 weeks of treatment when patients were switched to once daily oral paltusotine.

Aeterna Zentaris

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Aeterna Zentaris Announces Positive Results In Dose-Finding Pediatric Study Of Macimorelin

Lead Product(s): Macimorelin

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2020

Details:

Positive results provide clinical framework to advance the Company’s Pediatric Investigation Plan for macimorelin as a growth hormone deficiency diagnostic.

Neurocrine Biosciences

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Neurocrine Biosciences Provides COVID-19 Business Update

Lead Product(s): Crinecerfont

Therapeutic Area: Endocrinology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 03, 2020

Details:

Following the cancellation of the annual meeting of the Endocrine Society in March, the company plans to share the full data set from all four patient cohorts at the newly organized ENDO in June.

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Companies

Poxel

Poxel Successfully Raises €17.7 Million in a Capital Increase

Xeris Pharmaceuticals

Xeris Shares Findings From the Outpatient Portion of a Phase 2 Proof-of-Concept Study of Its Developmental Ready-to-Use (RTU) Glucagon

Creapharm

AzurRx BioPharma Enters into Packaging, Labeling and Distribution Agreement with Creapharm Clinical Supplies for MS1819 Trial Drug Product

Oramed Pharmaceuticals

Oramed Pharmaceuticals to Present at the 80th American Diabetes Association Scientific Session, to be Held Virtually This Year in June

Ascendis Pharma

Ascendis Pharma A/S Announces Top-line Data from Fixed Dose Portion of Phase 2 Trial Demonstrating Potential of TransCon™ PTH

Delpharm Group

AzurRx Announces Manufacturing Agreement with Delpharm for MS1819 Clinical Drug Product

Crinetics Pharmaceuticals

Crinetics Pharmaceuticals Announces Proposed Public Offering of Common Stock

Crinetics Pharmaceuticals

Crinetics Pharmaceuticals Reports Positive Interim Results for the ACROBAT Edge Phase 2 Trial of Paltusotine

Aeterna Zentaris

Aeterna Zentaris Announces Positive Results In Dose-Finding Pediatric Study Of Macimorelin

Neurocrine Biosciences

Neurocrine Biosciences Provides COVID-19 Business Update