Statera Bio pops 8% after FDA lifts clinical hold on Entolimod

Statera Biopharma (NASDAQ:STAB) perks up 7.8% premarket following an announcement that the FDA has lifted the clinical hold placed on its Entolimod research and development activity in acute radiation syndrome (ARS).
Based on the Company’s response, the FDA acknowledged that the Company satisfactorily addressed historical regulatory matters.
“We are pleased that the FDA’s clinical hold questions have been successfully addressed, allowing us to continue our clinical work in ARS and explore new indications for Entolimod in hematology, specifically treatment of neutropenia and anemia in cancer patients,” said Michael K. Handley, President and Chief Executive Officer, Statera Biopharma.
In addition, Statera is establishing a development program in Oncology and Hematology based on the potential that toll-like receptor 5 agonists, such as Entolimod, have shown in the treatment of neutropenia and anemia in cancer patients.
Discussions are underway with a renowned U.S. academic institution to initiate the first study of Entolimod in this new area of focus in 2022.