Repros Therapeutics announces FDA confirmation of endpoints for Androxal Repros Therapeutics announced it has received additional guidance from the FDA regarding primary endpoints for the two studies, ZA-304 and ZA-305, that it is currently conducting comparing Androxal to the leading approved testosterone gel and placebo. The FDA proposed three co-primary endpoints: Percentage change from baseline in sperm concentration comparing Androxal to the leading U.S. testosterone replacement therapy; proportion of men obtaining a testosterone in the normal range; percentage of men that exhibit sperm greater than or equal to 10M/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal to a testosterone gel as well as comparing Androxal to placebo. The primary endpoints and statistical analysis plan outlined for ZA-304 and ZA-305 below are being modified to comply with the FDA suggestions. The company believes the two studies are adequately powered to meet these endpoints.
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Repros needed unique Androxal label even before ADCOM panel, says Ladenburg Ladenburg said that given the FDA advisory committee's 20 to 1 vote that it believes the FDA will likely revise testosterone replacement therapy labels to restrict their use in hypogonadal patients with clear etiology. However, Ladenburg added that Repros was always going to have to establish a unique label for Androxal and the firm believes that the company's ongoing and completed trials will provide sufficient data for filing and approval by the FDA in secondary hypogonadism. The firm maintains its Buy rating and $35 price target on Repros.
Repros Therapeutics sell-off overdone, says Brean Capital Brean Capital said the selling in Repros Therapeutics is overdone after an FDA panel voted overwhelmingly in support for a more restrictive label that limits the use of TRT drugs to only patients with classic hypogonadism. The firm feels since Androxal has not been targeting age-related hypogonadism it does not deserve to be negatively impacted by yesterday's ruling. Brean Capital maintains its Buy rating on Repros Therapeutics and $41 price target on the shares.