Repros Therapeutics Inc.’s 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. , AMAG Pharmaceuticals Inc. (AMAG - Free Report) and Isis Pharmaceuticals, Inc. look more attractive with a Zacks Rank #1 (Strong Buy).