Cleveland BioLabs stock drops on BARDA news
The 24 percent drop to $1.82 resulted from the U.S. Health and Human Service's authority indicating that it will not invite the company to submit a funding proposal for CBLB502 to treat acute radiation syndrome, BioCentury reports.
"(BARDA) did not agree that our proposed studies were the proper studies to move ahead with FDA approval," Cleveland BioLabs said, according to BioCentury.
The company will meet with the U.S. Food and Drug Administration this month to discuss the design of additional animal and human studies needed for approval. Cleveland BioLabs anticipates that it will submit a new proposal to BARDA after the meetings with the FDA.
CBLB502, a radioprotective derivative of the TLR5 agonist flagellin, finished Phase IIa testing and is being developed under the FDA's animal rule. The rule allows for marketing approval to be granted based on relevant animal model efficacy and an acceptable safety risk profile in humans. As of December 31, Cleveland BioLabs had $28.4 million in cash with a 12 month operating loss of $25.1 million.
In May, BARDA indicated that the development path for CBLB502 would require clarification before additional contract negotiations could occur.