NEW YORK (AP) — Shares of Repros Therapeutics tumbled Wednesday after the company delayed its filing for marketing approval of its testosterone replacement Androxal for several months.
Repros said it now expects to file for approval in the fourth quarter of 2014, after it completes complete two studies of the drug. It had planned to make its filing in the middle of 2014.
The company said the Food and Drug Administration wants a year of study data on the effects of the highest dose of Androxal. The agency also told Repros to request a meeting to discuss the studies the company has conducted.
Shares of Repros Therapeutics Inc. lost $6.83, or 28.8 percent, to $16.86 in morning trading.
The Woodlands, Texas, company does not have any approved drugs. It is studying Androxal capsules as a treatment for a low-testosterone condition called secondary hypogonadism, and as a treatment for Type 2 diabetes in men. The drug blocks the production of the hormone estrogen, which helps the body produce more testosterone. It is Repros' most advanced experimental product.
Brean Capital Markets analyst Jonathan Aschoff said the FDA's requirements are stringent, but they could ultimately be a good thing for Repros and Androxal. The agency said Repros can run studies comparing Androxal to approved testosterone products. If Androxal works better than older drugs, it could speed up the drug's approval and increase its sales, Aschoff said. He wrote that despite the apparent delay, Androxal may be approved around the same time he had expected: the third quarter of 2015.
Aschoff rates the shares "Buy" with a price target of $14.
In January Repros said men at one testing site in one of its trials of Androxal had lower starting sperm counts and testosterone levels than other patients in the study, and they appeared to respond as well or better to Androxal than other patients.
The FDA and Repros will discuss whether results from that testing site can be excluded from the trial. The two sides agreed that results from another site where data fraud occurred can be excluded.
Repros shares dropped 40 percent to $11.11 on Jan. 28 after the company announced those problems. However they climbed 76 percent to $16.10 on March 28 after the company said the drug met its goals in the study.