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# FDA Lifts Entolimod Clinical Hold
- URL: https://www.fdaweb.com/fda-lifts-entolimod-clinical-hold/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150672

FDA has lifted its clinical hold on Statera Biopharma’s entolimod research and development activity in acute radiation syndrome. The company [says](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwiXmvTu9ML0AhWlhXIEHYBrAhA4HhDF9AEoAHoECBEQAg&url=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fstatera-biopharma-announces-fda-lifts-123200110.html&usg=AOvVaw2%5FOkRAuOcIls9XvSBuKDIk) that based on its response to the agency, FDA has acknowledged that Statera satisfactorily addressed historical regulatory matters.

The company says that on the basis of data demonstrating efficacy and safety in acute radiation syndrome, it intends to evaluate ongoing development requirements and medical needs for entolimod. It says it also is establishing a development program in oncology and hematology based on the potential that toll-like receptor 5 agonists like entolimod have shown in treating neutropenia and anemia in cancer patients.