ObsEva SA (OBSV) stock climbed in the pre-market after it announced the submission of a New Drug Application to U.S FDA for Linzagolix. OBSV stock price saw a push of 5.32% to reach $3.17 a share as of this writing. The stock was declining in the previous trade and went down by 2.27% at closing. Let’s discuss the ObsEva SA stock and its recent events.
ObsEva SA is the biopharmaceutical stock that develops and commercializes therapeutics regarding the health of women’s reproductive system.
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OBSV stock submitted New Drug Application (NDA) for Linzagolix to FDA:
Linzagolix is a GnRH receptor antagonist that treats uterine fibroids. It has shown best-in-class efficacy and safety profile. The NDA submission consists of treatment results obtained from 52-week clinical studies of Phase 3 PRIMROSE 1 and PRIMROSE 2. Moreover, NDA submission also includes supportive post-treatment results of 76 weeks. In both studies, patients with heavy menstrual bleeding (HMB) were dosed with 100mg or 200mg of Linzagolix with and without hormonal add-back therapy. Both PRIMROSE 1 and 2 met primary endpoints and all doses showed significant clinical reductions in HMB compared to placebo.
NDA submission for Linzagolix is an important milestone for OBSV stock to meet the needs of women with uterine fibroids in the U.S. If it gets approval, it will then first treatment option for women who are reluctant to take hormones. The management is striving hard to overcome the existing challenges with low and high doses of Linzagolix. OBSV stock is looking forward to work with FDA in the regulatory process as it prepares for commercialization.
Financial View of OBSV stock:
ObsEva SA announced second-quarter 2021 financial results on August 05, 2021, according to which
- OBSV stock reported a net loss of $19.1 million or $0.25 per share in the three months ended June 30, 2021. This compares to a net loss of $18.2 million, or $0.38 per share in the same tenure of the previous year.
- Research and development expenses for the OBSV stock were $14.5 million compared to $15.4 million. General and administrative expenses increased from $2.2 million in Q2,2020 to $3.9 million in Q2,2021.
- By the end of the second quarter, ObsEva SA had $58.9 million in cash and cash equivalents.
The announcement of the NDA submission has captivated the attention of investors towards ObsEva SA. The FDA approval will result in high demand for Linzagolix in the U.S. OBSV stock is also working with European Medicine’s Agencies in order to get marketing approval.