Repros Therapeutics Inc.
) reached a 52-week high of $28.30 in the first half of the
trading session on Sep 17. Shares of the company soared following
the announcement of encouraging top-line data from the
second pivotal efficacy study (ZA-302) and six-month safety study
(ZA-300) on its lead pipeline candidate, Androxal. The
company is evaluating the use of Androxal for the treatment of
men with secondary hypogonadism.
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The ZA-302 study met both the primary endpoints. The results
showed that 81% of the patients had average total testosterone in
a normal range. The second primary endpoint was related to the
drug's impact on sperm concentration. Results did not reveal any
harmful effects of Androxal on sperm function.
Repros also reported encouraging data from the ZA-300 study on
Androxal. The company stated that Androxal was generally
We note that earlier this year, the company had announced
encouraging top-line data from the first pivotal phase III study
(ZA-301). Both ZA-302 and ZA-301 were conducted under the FDA's
Special Protocol Assessment program.
The company is on track to file a New Drug Application to the
U.S. Food and Drug Administration (FDA) for Androxal by mid 2014
with potential launch in 2015.
Currently prescribed therapies for secondary hypogonadism include
Repros currently carries a Zacks Rank #2 (Buy). 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).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.