ObsEva Shares Gains On Positive Linzagolix Data In Uterine Fibroids Study

• ObsEva SA (NASDAQ: 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.

• Related content: Benzinga's Full FDA Calendar

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