Repros Therapeutics Inc.
) recently provided an update on its phase III program for
Androxal. The candidate is being evaluated for the treatment of
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The company announced that it has completed the enrollment
process for the one-year study, DEXA (ZA-303), evaluating the
effects of Androxal on bone mineral density. The company
completed the enrollment three months before the scheduled date.
The company expects to file a New Drug Application (NDA) for
Androxal primarily on the basis of data from the DEXA study by
The company plans to continue to enroll patients for study so
that the safety requirement of minimum exposure of 800 patients
for 6 months mandated by the US Food and Drug Administration
(FDA) is fulfilled.
Repros Therapeutics is also conducting a six-month open label
study, ZA-300 (n~500), to build a safety database as required by
the FDA. The company has recruited 415 patients and expects to
complete recruitment by the end of the first quarter of 2013.
We note that the Androxal phase III program also includes two
pivotal phase III studies, ZA-301 and ZA-302. While the ZA-301
study is currently underway, enrollment for the ZA-302 is
expected to completed shortly.
Repros Therapeutics is highly optimistic about the potential of
Androxal. The company believes that the candidate offers a safer
and more reliable treatment option for patients suffering from
secondary hypogonadism than the currently available drugs for the
We currently have a Neutral recommendation on Repros
Therapeutics. The stock carries a Zacks Rank #3 (Hold) in the
Pharma stocks, which currently look more attractive, are
). Both these companies carry a Zacks Rank #1 (Strong Buy).