Learn what Wall Street already knows in our "Billion Dollar Secret" guide.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating indiv idual securities.
If you wish to go to ZacksTrade, click
OK. If you do not, click Cancel.
Back to top
Repros Therapeutics Inc.’s ( RPRX - Analyst Report) lead pipeline candidate, Androxal, is being evaluated for the treatment of patients with secondary hypogonadism. The company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013.
In view of the guidance, Repros now expects to submit the new drug application (NDA) to the FDA in the fourth quarter of 2014. Earlier, the company had planned on submitting the NDA in mid-2014 with potential launch in 2015.
Proellex is another candidate in Repros’ pipeline. Proellex is being developed for uterine fibroids (vaginal delivery, phase IIb study expected to be initiated in early 2014) and endometriosis (oral delivery, phase II study expected to be completed in the second quarter 2014).
In Nov 2013, the company received guidance from the FDA related to the development of oral Proellex (low dose) for the treatment of uterine fibroids and endpoints acceptable for the treatment of uterine fibroids.
The FDA has asked Repros to submit a new protocol and request for the lifting of the full clinical hold. The company plans to start the studies on oral Proellex and vaginal delivery of Proellex for uterine fibroids at the same time and use the same design for both.
We remind investors that in 2009 data from a phase III efficacy study and phase III safety studies revealed that Proellex was associated with elevated liver enzymes. Consequently, the company stopped the studies and the FDA placed a clinical hold on Proellex.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal and Proellex updates.
However, companies like Actelion Ltd. ( ALIOF - Snapshot Report) , AMAG Pharmaceuticals Inc. ( AMAG - Analyst Report) and Isis Pharmaceuticals, Inc. look more attractive with a Zacks Rank #1 (Strong Buy).