Obseva SA Inc. (NASDAQ: OBSV) stock plunged by 2.27% at last close whereas the OBSV stock gains by 5.32% in the pre-market trading session. ObsEva is a pharmaceutical firm focused on the development and commercialization of innovative medicines to help women better their reproductive health and pregnancy outcomes.
OBSV stock’ Significant Development
ObsEva SA has presented a New Drug Application (NDA) for linzagolix for the cure of uterine fibroids to the US Food and Drug Administration (FDA). Linzagolix is an oral GnRH receptor antagonist that has the ability to be the best-in-class in terms of efficacy, tolerability, and dose options. Furthermore, if authorized, linzagolix will be the only GnRH antagonist with a low dose non-add-back therapy (ABT) option for uterine fibroids.
Positive 52-week on-treatment outcomes from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies, as well as encouraging data from the 76-week post-treatment follow-up study, are included in the NDA filing. Patients with heavy menstrual bleeding (HMB) due to uterine fibroids were given 100 mg or 200 mg of linzagolix, with or without hormonal add-back therapy (ABT; 1 mg estradiol/0.5 mg norethindrone acetate), or placebo in both studies. The primary objectives of PRIMROSE 1 and 2 were fulfilled, with all doses showing statistically meaningful and clinically important decreases in HMB when compared to placebo.
Brian O’Callaghan, CEO of ObsEva commented,
The NDA submission is a significant step in bringing linzagolix to the United States and tackling the wide range of medical requirements that women with uterine fibroids face. Linzagolix’s clinical relevance and well-known distinct profile are highlighted by their positive Phase 3 PRIMROSE results. Linzagolix, if authorized, will be the first oral GnRH antagonist to provide therapeutic choices for women who are unable or unwilling to take hormones, as well as those who are able to take extra hormone therapy. They are excited to overcome current challenges in treating uterine fibroids, and they will work closely with the FDA throughout the regulatory process as they prepare to commercialize their product.