Repros Therapeutics Inc
) recently released additional results from its phase III study,
ZA-300, on candidate Androxal.
Repros is evaluating Androxal for the treatment of low
testosterone due to secondary hypogonadism.
The results from the study showed that the change from
baseline in total testosterone compared to baseline values was
statistically different at various measurements including the two
follow-up visits, for the 12.5 mg dose.
The change was statistically significant at 25 mg dose as well
but the change was not significant after follow-up visists at the
end of two months. The results also showed that patients
continued to benefit even after withdrawal of treatment.
In Sep 2013, Repros had announced that Androxal was generally
well tolerated in the six-month safety study, ZA-300. We remind
investors that Repros had announced encouraging top-line results
in Sep 2013, from its second phase III study, ZA-302, on
Androxal. The study met both co-primary endpoints as mandated by
the U.S. Food and Drug Administration (FDA).
Last week, share price of Repros surged after its meeting with
the FDA. The meeting was held to discuss phase III data
requirements to file a New Drug Application (NDA) for Androxal.
Post meeting, the company came to the conclusion that no
additional safety studies would be required to support the NDA
submission of Androxal. The safety of Androxal will stand on its
own merit during NDA review.
Repros expects to submit the NDA to the regulatory body by end
Repros currently carries a Zacks Rank #3 (Hold). Androxal is
the most advanced candidate in Repros pipeline. Hence, we expect
investor focus to remain on Androxal updates. Some better-ranked
players in the pharma industry include
Biogen Idec Inc.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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