Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approval of Lymphoma Medicine Ukoniq (Umbralisib) Is Withdrawn Due to Safety Concerns
Details : Ukoniq (umbralisib), is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon, is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma.
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
June 01, 2022
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ublituximab,Umbralisib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The BLA/sNDA submissions of U2 to treat CLL were based on results of UNITY-CLL trial, comparing the combination of TG-1101 (ublituximab) plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both tre...
Product Name : TG-1101
Product Type : Large molecule
Upfront Cash : Not Applicable
March 03, 2022
Lead Product(s) : Ublituximab,Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Investigating Possible Increased Risk of Death With Lymphoma Medicine Ukoniq (umbralisib)
Details : The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm. And also experienced more serious adverse events than those in the control arm.
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
February 03, 2022
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ublituximab,Umbralisib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
TG Therapeutics Provides Regulatory Update
Details : The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.
Product Name : TG-1101
Product Type : Large molecule
Upfront Cash : Not Applicable
November 30, 2021
Lead Product(s) : Ublituximab,Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Umbralisib,Ublituximab
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
TG Therapeutics Provides Regulatory Update
Details : The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
November 30, 2021
Lead Product(s) : Umbralisib,Ublituximab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Umbralisib,Ublituximab,Venetoclax
Therapeutic Area : Oncology
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Company to review the updated Phase 1 data evaluating the investigational combination of UKONIQ® (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
September 13, 2021
Lead Product(s) : Umbralisib,Ublituximab,Venetoclax
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ublituximab,Umbralisib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : TG Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Samsung Biologics & TG Expand Collaboration for Large Scale Mfg of Ublituximab
Details : TG Therapeutics has completed a rolling submission of a BLA to the U.S. FDA requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), as a treatment for patients with CLL, based on the positive results from the UNITY-CLL Phase 3 tria...
Product Name : TG-1101
Product Type : Large molecule
Upfront Cash : Undisclosed
April 26, 2021
Lead Product(s) : Ublituximab,Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : TG Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Rhizen Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
February 08, 2021
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Rhizen Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Rhizen Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
TG Therapeutics Announces FDA Accelerated Approval of UKONIQ™ (Umbralisib)
Details : UKONIQ is the first and only, oral, once daily, inhibitor of phosphoinositide 3 kinase delta and casein kinase 1 epsilon. UKONIQ is approved for adult patients with relapsed or refractory marginal zone lymphoma after at least one prior anti-CD20 based re...
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
February 05, 2021
Lead Product(s) : Umbralisib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Rhizen Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Umbralisib,Ublituximab
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TG Therapeutics has initiated a rolling submission of a Biologics License Application to the U.S. FDA requesting approval of ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, an oral, dual inhibitor of PI3K-del...
Product Name : Ukoniq
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
December 01, 2020
Lead Product(s) : Umbralisib,Ublituximab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable