Abeona Therapeutics (Nasdaq: ABEO), a clinical-stage biopharmaceutical firm based in Cleveland, announced it has raised $25 million from “select existing investors” to help launch and commercialize its EB-101 cell therapy.
The offering was led by Nantahala Capital Management LLC. It included participation by Adage Capital Partners LP and two other existing institutional investors that Abeona did not identify. The offering will close on or about Thursday, July 6, according to an Abeona news release.
Stay sharp—subscribe to the Daily Finance newsletter.
Abeona said in the release that it will use the funding to prepare for launch activities in anticipation of filing the Biologics License Application (BLA) with the U.S. Food and Drug Administration for the future approval of EB-101, as well as for working capital and general corporate purposes.
The company already has received from the FDA a Rare Pediatric Disease designation for EB-101, which is an autologous, engineered cell therapy that Abeona is developing to treat recessive dystrophic epidermolysis bullosa.
As a result, Abeona said it “expects to qualify to receive a priority review voucher (PRV) upon BLA approval and subject to final determination by the FDA.” The PRV “can be used to receive an expedited review process of a subsequent marketing application for a different product or sold to another company to create additional capital to fund the EB-101 launch,” Abeona said.
>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Modern Healthcare – https://www.modernhealthcare.com/finance/abeona-therapeutics-gene-therapy-bla