The FDA is keeping its partial hold on Repros’ Proellex
Repros Therapeutics $RPRX says that the FDA plans to maintain the partial clinical hold on Proellex so regulators can take extra time in consulting with agency experts on the liver effects spotted in the clinic. But they expect to be able to answer the agency’s request for information and offer a planned protocol in a matter of weeks.
Repros had told investors their meeting with the FDA would be an end of Phase II sit-down. But that changed to a guidance session on this drug.
The tiny biotech, based in Woodlands, TX, has a market cap of only $29 million.
Proellex has been on hold before, starting in 2010 when the agency raised safety concerns and continuing in 2012. Then in late 2015, the FDA rejected its drug for secondary hypogonadism, a reproductive disorder characterized by low testosterone.
In addition, Larry Dillaha has won the CEO’s job after holding the interim title since February.
Dillaha commented, “The Company is pleased with the guidance received from the FDA, and while we remain on the current partial clinical hold as the FDA internally reviews our data related to the effect of Proellex on the liver, we will proceed with our development plans by submitting additional phase 2 protocols to the FDA for their review. We are committed to working closely with the FDA as we further our development program for Proellex.”