FDA

FDA keeps a firm grip on partial hold for troubled Repros Therapeutics, with big trial demand

The news isn’t getting any better at Repros Therapeutics $RPRX. Early Monday the Woodlands, TX-based biotech put out the word that the partial hold placed on the Proellex program will remain in place after regulators made clear that the biotech will need to assemble a “large” safety database on the drug ahead of any approval. And that report sent its already tattered shares into a fresh tailspin.

“Our discussions with the FDA, and their guidance that a large safety data base will be required to continue the development of Proellex, indicate that a much larger clinical trial, with associated time and cost requirements, would be necessary,” said new CEO Larry Dillaha in a prepared remark.

The block leaves Repros in a bind on the oral therapy for uterine fibroids or endometriosis, forcing the penny stock biotech to take a look and see how a vaginal delivery approach could make the difference.

Repros has a long history of regulatory trouble. Proellex was temporarily put on a full hold in 2009 as regulators fretted about potential liver damage. That hold was lifted after the company shifted to a lower dose. Its low-T treatment Androxal was spurned by the FDA in 2015 at a time testosterone therapies were under a cloud.

In the meantime, its shares have been whittled down. After closing at 58 cents on Friday, with a market cap of only $17 million, the stock plunged about 50% on Monday morning.


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