OBSV - ObsEva warns a potential delay in European marketing authorization for linzagolix

ObsEva (NASDAQ:OBSV) is trading ~5% lower in the post-market on Friday after the company announced that its European marketing authorization for linzagolix could extend. Linzagolix is a once-daily, oral GnRH receptor antagonist which has undergone late-stage trials for uterine fibroids. Based on the ongoing discussions with the European Medicines Agency (EMA), the company notes further questions could be expected from regulators regarding the marketing authorization application. The company is in talks with the EMA to identify areas for clarifications, and “is committed to promptly addressing any questions that could arise,” ObsEva (OBSV) said. In a deal with Kissei in late 2015, ObsEva (OBSV) licensed the global commercial rights for linzagolix excluding Asia.

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ObsEva warns a potential delay in European marketing authorization for linzagolix