- ObsEva SA (NASDAQ:OBSV) announces positive results from a Phase 3 clinical trial, PRIMROSE 1, evaluating Yselty (linzagolix) in women with heavy menstrual bleeding due to uterine fibroids.
- The study met the primary endpoint demonstrating a statistically significant proportion of responders at week 24, defined as those experiencing a reduction from baseline in menstrual blood loss at week 24 of ≤80 mL and ≥50%. Specifically, 75.5% of women who received the 200 mg dose with add-ack therapy (ABT) and 56.4% of those receiving the 100 mg dose without ABT responded.
- The company does not disclose whether a sister Phase 3, PRIMROSE 2, met the primary endpoint, only stating that pooled week 24 data from the two trials showed an 84.7% responder rate in women receiving the 200 mg dose with ABT and 56.6% in women receiving the 100 mg dose without ABT.
- As far as specific results from PRIMROSE 2, it reports results from week 52, specifically, a 91.6% response rate in the 200 mg + ABT cohort and 53.2% in the 100 mg without ABT cohort.
- It plans to file a marketing in Europe in Q4 and in the U.S. in H1 2021.
- Management will host a conference call this morning at 8:00 am ET to discuss the results.
- Shares up 12% premarket on light volume.