In an update announced last month, ObsEva reported that, pursuant to Phase 3 results, the European Medicines Agency ( ) had validated for review the company’s Marketing Authorization Application ( MAA ) for Yselty (100mg and 200mg). Potential MAA approval is anticipated in Q4:21. The drug is also slated to be the subject of a New Drug Application ( NDA ) that is due to be submitted to the FDA in Q2.
Wedbush analyst Liana Moussatos said that Linzagolix has the potential to achieve best-in class oral GnRH receptor antagonist status based on a flexible dosing regimen either with or without the add-back hormone therapy ( ABT )—a key differentiator from other GnRH receptor antagonists… Based on the positive PRIMROSE 1 and PRIMROSE 2 primary endpoint results for YSELTY®/UF and additional follow-up data, we project annual sales of more than $750 million in 2027 for Linzagolix/UF,” Moussatos opined.
To this end, Moussatos rates OBSV a Buy along with a $28 price target.