FDA to Repros: Wipe your PhIII drawing board clean and start over

A month after taking a severe beating at the hands of disappointed investors, Repros Therapeutics ($RPRX) has confirmed what company execs had already hinted at: The FDA has rejected its long-delayed low testosterone therapy after regulators determined that the agency would need to see data from a new Phase III study before it could determine if the treatment is worth a green light.

The existing Phase III data, says the Woodlands, TX-based biotech, "is no longer adequate to demonstrate clinical benefit" and raised red flags around the study entry criteria, titration and bioanalytical method validation.

Shares of Repros plunged 31% on the news concerning enclomiphene (formerly Androxal), leaving the biotech with a market cap of around $40 million.

The news, though, could not have been a huge surprise to most investors, who joined a rout at the end of October after the FDA scrapped an advisory meeting and the company noted the agency's concerns about the way its chosen lab conducted testosterone tests on the men in the study.

The biotech has stumbled repeatedly at the FDA, though there was a point when positive head-to-head studies with competitors raised hopes in some quarters that an approval was possible.

"We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation," said Joseph Podolski, president and CEO of Repros, in a statement. "We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."

- here's the release

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.