Oncology | Phase II/ Phase III Developments | UNITED STATES

Tyme Technologies

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TYME Announces Abstracts Selected for Presentation at the American Association for Cancer Research, AACR 2020

Lead Product(s): Alpha-Methyltyrosine

Therapeutic Area: Oncology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 15, 2020

Details:

Preclinical data suggests multiple mechanisms of action for SM-88, including an increase in reactive oxygen species, alterations in autophagy and immunomodulation.

TG Therapeutics

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TG Therapeutics Receives Orphan Drug Designation for Umbralisib

Lead Product(s): Umbralisib,Ublituximab,Bendamustine

Therapeutic Area: Oncology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 05, 2020

Details:

Both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints .

Y-mAbs Therapeutics

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Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab

Lead Product(s): Omburtamab

Therapeutic Area: Oncology

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 26, 2020

Details:

The Company reached alignment with the FDA on an Accelerated Approval Pathway for omburtamab along with a rolling BLA submission.

Curis

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Curis and Aurigene Announce Amendment of Collaboration

Lead Product(s): 3-Aminopyrrolidine dihydrochloride

Therapeutic Area: Oncology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Aurigene

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration February 06, 2020

Details:

Aurigene to fund and conduct a Phase 2b/3 randomized study of CA-170 in patients with non-squamous non-small cell lung cancer. Curis retains U.S., E.U., and rest of world rights to CA-170.

United Therapeutics

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United Therapeutics Announces Study of Unituxin® (dinutuximab)

Lead Product(s): Dinutuximab

Therapeutic Area: Oncology

Highest Development Status: Phase II/ Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 03, 2020

Details:

The DISTINCT trial did not meet its primary efficacy objective of extending the overall survival with Unituxin and irinotecan versus using irinotecan alone.

TG Therapeutics

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Umbralisib Developer Seeks FDA Approval In Marginal Zone Lymphoma and Follicular Lymphoma

Lead Product(s): Umbralisib,Ublituximab,Bendamustine

Therapeutic Area: Oncology

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 16, 2020

Details:

Drug manufacturer TG Therapeutics, Inc., initiated a rolling application of an NDA for umbralisib seeking rapid FDA approval of the drug for the intended clinical use.

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Tyme Technologies

TYME Announces Abstracts Selected for Presentation at the American Association for Cancer Research, AACR 2020

TG Therapeutics

TG Therapeutics Receives Orphan Drug Designation for Umbralisib

Y-mAbs Therapeutics

Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab

Curis

Curis and Aurigene Announce Amendment of Collaboration

United Therapeutics

United Therapeutics Announces Study of Unituxin® (dinutuximab)

TG Therapeutics

Umbralisib Developer Seeks FDA Approval In Marginal Zone Lymphoma and Follicular Lymphoma