Update for April 19, 2022

Regulatory Update
 
TG Therapeutics voluntarily withdrew the pending BLA/sNDA for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma due to lower overall survival compared to obinutuzumab plus chlorambucil in the UNITY-CLL trial. TG Therapeutics also voluntarily withdrew umbralisib (Ukoniq) from the market. Umbralisib had been approved in February 2021, under an accelerated approval, for the treatment of relapsed or refractory marginal zone lymphoma or refractory follicular lymphoma.
 
The FDA designated celiprolol a Breakthrough Therapy for the treatment of vascular Ehlers Danlos Syndrome.
 
Coeptis Therapeutics bought marketing and development rights for entolimod from Statera Biopharma.
 
Announced Research Updates
 
Nektar and BMS announced results from the PIVOT 09 and PIVOT 10 trials, along with a decision on future development of the combination.
 
Published Research Updates
 
ICER released a draft review of betibeglogene autotemcel for the treatment of beta thalassemia.
 
Results were published for a Phase I/II trial, evaluating rilzabrutinib in the treatment of patients with immune thrombocytopenia (ITP).