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Lead Product(s): Fluasterone
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 02, 2020
Details:
SteroTherapeutics will provide the study drug (non-androgenic analogue of dehydroepiandrosterone) and placebo to enable the NICHD to conduct the Phase 2 clinical trial in the treatment of the manifestations of Cushing syndrome.
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Lead Product(s): Ibutamoren
Therapeutic Area: Endocrinology Product Name: LUM-201
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 November 10, 2020
Details:
The trial will evaluate three dose levels of LUM-201 in PGHD patients against a comparator arm of standard-of-care injectable growth hormone therapy.
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Lead Product(s): MS1819,Porcine enzyme replacement therapy
Therapeutic Area: Endocrinology Product Name: MS1819
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: AzurRx BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 10, 2020
Details:
Under the terms of the agreement, Asymchem will implement fermentation, verify protein expression and ultimately fine-tune the technology suitable for production of MS1819.
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Lead Product(s): MBX-2982
Therapeutic Area: Endocrinology Product Name: MBX-2982
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 November 05, 2020
Details:
The objective of the study is to determine if GPR119 agonists have potential to prevent hypoglycemia for people living with T1D. The trial is funded by a nearly $1.2 million grant from The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley).
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Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
The poster titled, “Glycemic Effects of Bedtime Oral Insulin (ORMD-0801) in Uncontrolled Type 2 Diabetes Mellitus Patients” will be presented at American Association of Pharmaceutical Scientists 2020 PharmSci 360 Conference.
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Lead Product(s): TransCon PTH
Therapeutic Area: Endocrinology Product Name: TransCon PTH
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
TransCon PTH is a once-daily long-acting prodrug of parathyroid hormone in development for the treatment of adult HP, which is designed to replace PTH at physiologic levels for 24 hours each day to address both the short-term symptoms and long-term complications of HP.
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Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
Based on guidance received from the U.S FDA as part of the End-of-Phase 2 meeting process for our oral insulin candidate, ORMD-0801, Oramed has submitted to the FDA the protocols for its upcoming pivotal Phase 3 studies.
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Lead Product(s): Eftansomatropin
Therapeutic Area: Endocrinology Product Name: TJ101
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Genexine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
The phase 3 trial is a study designed to assess the safety, efficacy and pharmacokinetics of eftansomatropin in PGHD. The primary objective is to demonstrate non-inferiority of eftansomatropin administered in subcutaneous injection, compared to the active control Norditropin®.
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Lead Product(s): TTP399
Therapeutic Area: Endocrinology Product Name: TTP399
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 September 23, 2020
Details:
The data presented at EASD add to the growing body of evidence supporting the potential of TTP399 to meet the urgent yet still unmet need for an adjunctive therapy for patients living with T1D that improves disease management and health outcomes.
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Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
Highest Development Status: Phase II Product Type: Peptide
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