OBSV - ObsEva shares gains 7% on final Yselty results in uterine fibroids
ObsEva (OBSV) perks up 7% premarket after announcing final 76-week results from the PRIMROSE 1 study of Yselty (linzagolix), in development for the treatment of women with heavy menstrual bleeding due to uterine fibroids.These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 and PRIMROSE 2 studies.The PRIMROSE 1 post-treatment results are consistent with findings from the PRIMROSE 2 study, showing that off-treatment pain scores remained lower than baseline across all treatment arms.Improvements hemoglobin levels and quality of life also persisted off-treatment, supporting the durability of the treatment effect of Yselty.Furthermore, as observed in PRIMROSE 2, the PRIMROSE 1 DXA results at Week 76 showed evidence of bone mineral density ((BMD)) recovery for patients treated with both the 100 mg and 200 mg+ ABT (add-back therapy) doses. The company said its EU MAA review is ongoing and its continues to prepare for U.S. NDA submission in Q3 2021.
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ObsEva shares gains 7% on "final" Yselty results in uterine fibroids