ObsEva Shares Gains On Positive Linzagolix Data In Uterine Fibroids Study

ObsEva SA OBSV has announced final 76-week results from the PRIMROSE 1 Phase 3 clinical study evaluating Yselty (linzagolix) for heavy menstrual bleeding due to uterine fibroids.
These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and US) studies.
The PRIMROSE 1 post-treatment results showed that off-treatment pain scores remained lower than baseline across all treatment arms.
Improvements in other clinically relevant secondary endpoints, including hemoglobin levels and quality of life, also persisted off-treatment, supporting the durability of the treatment effect of Yselty.
Furthermore, DXA results at week 76 showed evidence of bone mineral density recovery for patients treated with both the 100 mg and 200 mg+ add-back therapy dose.
The European marketing application is under review, with US application submission expected in Q3 2021.
Additional efficacy and safety data will be shared at upcoming scientific conferences this year.
Price Action: OBSV shares are up 7.07% at $3.03 during the premarket session on the last check Thursday.
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