OBSV - ObsEva stops US Phase 3 study with Yselty for endometriosis

ObsEva ([[OBSV]] -4.5%) has announced validation of European marketing application seeking approval for Yselty (linzagolix) for the Treatment of uterine fibroids.The Yselty Europe application is based on positive data from the Phase 3 PRIMROSE 1 and PRIMROSE 2 studies. The company is on track to submit the Yselty US application in 1H of 2021, and anticipates follow-up data and 6-month post treatment assessment data in Q1 2021.EDELWEISS 3 trial of Yselty for endometriosis in the EU is progressing as planned, with primary endpoint data expected in 4Q 2021.Though due to pandemic-related enrollment challenges, the company has decided to discontinue Phase 3 EDELWEISS 2 in the U.S. for Yselty in endometriosis. No new or significant safety issues have been observed. The company says that this step will enable conserve over $30M.

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ObsEva stops US Phase 3 study with Yselty for endometriosis