Thinly traded nano cap Cleveland BioLabs (NASDAQ:CBLI) is up 28% premarket on increased volume in response to is announcement that the European Medicines Agency (EMA) has accepted its pediatric investigation plan (PIP) related to radiation countermeasure entolimod. The action clears the way for the company to file its Marketing Authorization Application (MAA) seeing approval to sell the product in the EU.
The company says its existing data, combined with future nonclinical cell culture experiments and formulation, should be sufficient to support pediatric labeling. The future work can be performed after the MAA submission.
Entolimod is a recombinant protein that acts as an agonist of toll-like receptor 5 (TLR5), an innate immunity receptor.
Previously: Cleveland Bio snags $9.2M DoD contract to develop entolimod (Sept. 2, 2015)