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Provention Bio

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Drug Discovery Chemistry

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Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes

Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology

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 March 16, 2020

Details:

PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis

Oramed Pharmaceuticals

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Oramed Pharmaceuticals Inc. Prices Public Offering of Common Stock for Aggregate Proceeds of $21 Million

Lead Product(s): Exenatide

Therapeutic Area: Endocrinology

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: National Securities Corporation

Deal Size: $21.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 27, 2020

Details:

The Company intends to use the net proceeds of the offering for its anticipated Phase 3 clinical trial in ORMD-0801 and for other clinical trials and R&D activities.

Lipocine

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Lipocine Announces Regulatory Path Forward for TLANDO™ Resubmission

Lead Product(s): Testosterone Undecanoate

Therapeutic Area: Endocrinology

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 February 24, 2020

Details:

The FDA requested that the information generated by the reanalysis be submitted as part of an NDA resubmission with a six-month Prescription Drug User Fee Act clock.

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Provention Bio

Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes

Oramed Pharmaceuticals

Oramed Pharmaceuticals Inc. Prices Public Offering of Common Stock for Aggregate Proceeds of $21 Million

Lipocine

Lipocine Announces Regulatory Path Forward for TLANDO™ Resubmission