Repros Therapeutics Inc.
) share price increased 1.2% last week on the announcement that
the company has initiated two studies on its secondary
hypogonadism candidate, Androxal. Since then, the company has
gained approximately 5.4%.
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The two identical, 17-week, double-blinded, placebo controlled
studies will compare the safety and efficacy of Androxal with a
testosterone replacement therapy (topical gel) in restoring and
maintaining testicular function. Both studies will enroll 120 men
each. Top-line data from the studies are expected by Oct 2014.
Repros plans to submit the new drug application (NDA) to the U.S.
Food and Drug Administration (FDA) in the fourth quarter of 2014.
Repros has already obtained the Investigational Review Board
approval for several of the study sites. Meanwhile, several sites
have started pre-screening patients with the drug shipment for
the trial expected shortly.
We remind investors that the company had received guidance from
the FDA related to the Androxal development program in Oct 2013.
In view of the guidance, Repros delayed the regulatory submission
from the previously expected timeline of mid-2014.
Last year, the company had announced encouraging top-line data
from the first pivotal phase III study (ZA-301) and the second
pivotal efficacy study (ZA-302), which evaluated Androxal for
secondary hypogonadism. Both ZA-301 and ZA-302 - conducted under
the FDA's Special Protocol Assessment (SPA) program - had met
their respective primary endpoints.
We believe that Repros stands to benefit from the additional
trials as data, if positive, can be added to the label. Currently
prescribed therapies for secondary hypogonadism include
Repros currently carries a Zacks Rank #3 (Hold). We expect
investor focus to remain on Androxal updates. Some better-ranked
stocks in the biopharma space include
). Both carry a Zacks Rank #1 (Strong Buy).