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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): 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): 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
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The presentation will highlight study titled: Evening oral insulin (ORMD-0801) glycaemic effects in uncontrolled type 2 diabetes patients.
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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 16, 2020
Details:
The oral presentation will illustrate findings from the Simplici-T1 Trial which showed that activation of glucokinase by TTP399 enhances glycaemic control in patients with Type 1 Diabetes.
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Lead Product(s): Paltusotine
Therapeutic Area: Endocrinology Product Name: CRN00808
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 04, 2020
Details:
A presentation on the company’s orally administered, small molecule adrenocorticotropic hormone (ACTH) antagonist was selected for a late-breaking session at the virtual European Congress of Endocrinology (eECE).
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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: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
In the primary efficacy analysis, patients receiving MS1819 in combination with PERT therapy achieved a clinically meaningful improvement in the coefficient of fat absorption (CFA) at each of the three dose levels, with no adverse safety events reported.
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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: Undisclosed
Deal Size: $22.1 million Upfront Cash: Undisclosed
Deal Type: Private Placement July 20, 2020
Details:
Private placement will be used to advance two Phase 2 clinical trials of MS1819 in patients with cystic fibrosis.
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Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: ORMD-0801
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 July 15, 2020
Details:
The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. Oramed plans to conduct the two Phase 3 trials concurrently.
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Lead Product(s): Paltusotine
Therapeutic Area: Endocrinology Product Name: CRN00808
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 July 08, 2020
Details:
The orphan drug designation by the FDA for paltusotine to treat acromegaly validates the encouraging clinical data that has been observed so far in the Phase 2 ACROBAT Edge clinical trial.
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