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.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 30,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Convergence 2018

Technical Operations Manager
Molecular Templates Austin, TX
Senior Director, Global Commercial Strategy, Rare Disease
Govig BioPharma/Aeglea BioTherapeutics Austin, TX
Senior Manager, Sales & Client Development
Aldevron Boston or San Francisco
Scientist, Cellular Immunology
Codiak BioSciences Cambridge, MA
Director of Quality Assurance
Aldevron Fargo, ND
Principal Scientist, Immuno-Oncology (Inflammation)
Codiak BioSciences Cambridge, MA

Visit Endpoints Careers ->