ObsEva implodes on warning that the FDA has set up a roadblock for its flagship drug
Just weeks after scoring an approval for its flagship drug in Europe, ObsEva has run into a regulatory maelstrom in the US that has eviscerated its market cap and forced it to seek a court-appointed administrator in Switzerland while restructuring the company and considering what “strategic options” it might have.
The biotech reported early Wednesday that the FDA has raised issues “regarding deficiencies in the New Drug Application (NDA) for linzagolix for uterine fibroids. These review issues preclude discussion of labeling and post-marketing commitments at this time. “
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