- HC Wainwright has downgraded ObsEva SA OBSV from a Buy to Neutral without a price target.
- Late last month, the FDA notified ObsEva of review issues regarding deficiencies in the linzagolix application for uterine fibroids. These review issues preclude discussion of labeling and post-marketing commitments at this time.
- ObsEva said that the resolution of the identified review issues might not be feasible by the September 13 target action date under the Prescription Drug User Fee Act.
- According to HC Wainwright, the agency may require additional pivotal studies, which could preclude drug approval in the U.S. for an extended time and render it commercially non-viable.
- "We do not expect ObsEva to be able to realize any revenues from linzagolix going forward," the analyst said.
- ObsEva will restructure its operations to support existing license agreements, including Organon & Co OGN for ebopiprant and its sublicense agreement with Yuyuan BioScience for nolasiban in China.
- Additionally, the analyst writes that ObsEva will assess strategic options for pipeline development and the worldwide rights it holds for nolasiban, excluding China.
- Price Action: OBSV shares are down 2.09% at $0.20 on the last check Tuesday.
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