HC Wainwright has downgradedObsEva SAOBSV 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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