Downsized FerGene gains FDA extension to resubmit gene therapy, resolve CMC issues

A year after Blackstone-backed Ferring subsidiary FerGene received a complete response letter for its gene therapy for bladder cancer, investors in the downsized biotech remain committed to the project as it plans to resubmit its BLA by next spring.

A spokesperson for Ferring Pharmaceuticals A/S told BioCentury that the company has requested and obtained a 12-month extension to resolve outstanding questions around CMC and manufacturing, and then resubmit its BLA to FDA. The extension sets a new deadline of April 2022; if it can obtain priority review, the agency’s decision could come down by YE22...