By Michael Dabaie


Statera Biopharma Inc. said the U.S. Food and Drug Administration lifted the clinical hold placed on Entolimod research and development activity in acute radiation syndrome, sending shares higher premarket.

Statera said that based on its response, the FDA acknowledged that the company satisfactorily addressed historical regulatory matters.

Statera shares rose about 6% to $3.11 in premarket trading.

Acute radiation syndrome, sometimes known as radiation toxicity or radiation sickness, is an acute illness caused by a high dose of penetrating radiation in a short period of time, according to the U.S. Centers for Disease Control and Prevention.

"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 Statera Chief Executive Michael K. Handley.

Based on the data demonstrating efficacy and safety in acute radiation syndrome, Statera said it intends to evaluate ongoing development requirements and medical needs for Entolimod.

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.

Statera said discussions are underway with a U.S. academic institution to initiate the first study of Entolimod in this new area of focus in 2022.


Write to Michael Dabaie at


(END) Dow Jones Newswires

December 01, 2021 08:16 ET (13:16 GMT)

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