Repros Therapeutics Inc.
) recently announced six months interim results from the ongoing
ZA-303 study on its lead pipeline candidate, Androxal. The study
is evaluating the impact of Androxal therapy on bone
mineral density in men suffering from secondary hypogonadism .
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Interim data from the single-blind, placebo-controlled study
suggested that the use of Androxal did not result in bone loss as
compared to placebo. Additionally, data hinted that Androxal may
improve bone mineral density.
Top-line twelve-month data from the study are expected in the
second quarter of 2014. The company plans to file a New Drug
Application to the U.S. Food and Drug Administration (FDA) for
Androxal by mid 2014.
The company is also evaluating Androxal in other studies for
secondary hypogonadism including two pivotal phase III studies
conducted under the FDA's Special Protocol Assessment program.
Earlier this year, the company had announced encouraging top-line
data from the first pivotal phase III study (ZA-301). The second
pivotal phase III study is expected to be completed in the fourth
quarter of 2013.
Currently prescribed therapies for secondary hypogonadism include
Apart from Androxal, Proellex is another interesting pipeline
candidate at Repros. Proellex is being developed for uterine
fibroids (phase IIb study expected to be initiated in the fourth
quarter 2013) and endometriosis (phase II study expected to be
completed in the second quarter 2014).
Repros currently carries a Zacks Rank #4 (Sell). We expect
investor focus to remain on Androxal updates.
Currently, companies like
Biogen Idec Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).