ObsEva tanks as FDA puts up hurdles for linzagolix NDA

Shares of Switzerland-based ObsEva (SIX: OBSN) fell as much as 80% yesterday, after the women’s health therapy developer revealed it has hit a stumbling block in the US approval of its linzagolix for uterine fibroids.

ObsEva announced that it plans to initiate a corporate restructuring and refocus the company’s development and commercialization strategy.

ObsEva believes the changes are necessary due to the commercial landscape and potential additional capital needed to fund the completion of the linzagolix clinical development program, as the US Food and Drug Administration (FDA) has notified the company of review 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.