FDA Pulls Hold on Statera’s Entolimod for Acute Radiation Syndrome

The FDA has lifted the clinical hold it placed in 2019 on the research and development of Entolimod for acute radiation syndrome (ARS), allowing new owner Statera Biopharma to proceed with plans to look at the molecule in cancer patients.

Entolimod secured Orphan Drug status in 2010, when it was being developed by Cleveland Biolabs.

The company was ready to ask for an Emergency Use Authorization (EUA) when the FDA issued the clinical hold in late 2019, according to a filing with the Securities and Exchange Commission. At issue was a trial design, which Statera said has now been addressed.