ObsEva SA (OBSV) is a biotechnology firm that focuses on the development and commercialization of innovative therapies to improve reproductive health in women. In the pre-market session today, the company stock has soared 34.52 percent to $3.39.
What Does The Company Do:
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ObsEva has established an advanced clinical pipeline as well as the development of treatments for uterine fibroids, endometriosis, and preterm labor through strategic licensing, a disciplined drug development plan, and sustained in-company investment.
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The company released several important updates to its Yselty program recently. These include the sending of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). MAA is essential to the marketing of the product during drug development in the EU and its validation indicates the start of the review process.
The company has attached the Phase 3 PRIMROSE 1 study and PRIMROSE 2 data with the Yselty MAA for uterine fibroids indication. Yselty doses of 100 mg or 200 mg, with and without hormonal add-back-therapy, or placebo were given to uterine fibroids patients with heavy menstrual bleeding (HMB).
ObsEva also shared that clinical development programs associated with endometriosis are a priority for them. Also in the EU, the EDELWEISS 3 trial is progressing according to plan, with primary endpoints scheduled to be available by the end of the year.