ObsEva SA OBSV said that based on ongoing communications with the European Medicines Agency (EMA), it expects further questions on the linzagolix application, thereby extending the application timeline. 

• ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.
• In December, EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of linzagolix for uterine fibroids.
• In the U.S., the linzagolix application for uterine fibroids has been accepted for review by the FDA, with a PDUFA target action date of September 13, 2022.
• Last month, ObsEva announced results from the Phase 3 EDELWEISS 3 trial of linzagolix for moderate-to-severe endometriosis-associated pain (EAP). 
• Two doses were tested, a 200 mg once-daily dose of linzagolix combined with add-back therapy (ABT) and a 75 mg dose of linzagolix without ABT.
• The 200 mg and 75 mg doses demonstrated reductions in dysmenorrhea. 
• Also, 200 mg showed reduced non-menstrual pelvic pain at three months. However, 75 mg did not reach statistical significance versus placebo. 
• Price Action: OBSV shares are down 2.10% at $1.40 during the premarket session on the last check Monday.