Repros Therapeutics meets with FDA to discuss data requirements for Androlax Repros Therapeutics announced the outcome of its previously announced meeting with the FDA regarding the Androxal Phase 3 data requirements for an NDA in the treatment of secondary hypogonadism. Repros expects to maintain its timeline for submitting an NDA prior to the end of 2014. This submission will include studies ZA-304 and ZA-305 which were initiated in January 2014. Following the meeting, the Company understands that the safety of Androxal will stand on its own merits during NDA review and no additional safety assessments are currently planned prior to NDA submission. The FDA requested additional background information regarding the endpoints that the company will use to confirm maintenance of fertility by semen assessments in studies ZA-304 and ZA-305. The company plans to provide this information promptly to the FDA and while doing so to continue enrollment of ZA-304 and ZA-305 without interruption.
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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.