Repros Therapeutics Inc.
) have been on an upswing since 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 patients with secondary
The subsequent announcement of additional positive top-line data
from the ZA-302 study helped in the maintenance of the upward
trend. We note that ZA-302 met both the primary endpoints. The
results showed that 81% of the patients had average total
testosterone in a normal range as compared to 26% in placebo. 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.
We note that earlier this year, the company had announced
encouraging top-line data from the first pivotal phase III study
(ZA-301). ZA-301 had met both the primary endpoints. Both ZA-302
and ZA-301 were conducted under the FDA's Special Protocol
Repros also reported encouraging data from the ZA-300 study on
Androxal. The company stated that Androxal was generally
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).
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