- The stock price of ObsEva SA (NASDAQ: OBSV) has increased by 61.51% on Friday, January 15. This is why it happened.
The stock price of ObsEva SA (NASDAQ: OBSV) — a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health — has increased by 61.51% on Friday, January 15. There are a few reasons why ObsEva’s stock price has been increasing over the past week.
On January 11, ObsEva provided an update on the Yselty (Linzagolix) clinical development program. The Marketing Authorization Application (MAA) is an application for approval submitted to the European Medicines Agency (EMA) and it is a critical step in marketing a product in the EU.
And the Yselty MAA for the uterine fibroids’ indication is based on data from the Phase 3 PRIMROSE 1 study (conducted in the US, which enrolled 574 women with uterine fibroids) and PRIMROSE 2 (conducted in Europe and the US, which enrolled 535 women with uterine fibroids). For both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered Yselty doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol/0.5 mg norethisterone acetate), or placebo.
PRIMROSE 1 and 2 had successfully met their primary endpoint with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo. And there was a clear efficacy dose-response with the highest responder rates for the primary endpoint observed in women who received the 200 mg with ABT dose.
Highly significant efficacy was also achieved for the low-dose 100 mg non-ABT regimen. And substantial improvements were also observed with all doses for the secondary endpoints of amenorrhea, time to reduced menstrual blood loss, hemoglobin levels in anemic subjects, pain, and quality of life.
ObsEva is anticipating follow-up data and 6-month post-treatment assessment data in Q1 2021.
The clinical development program for the endometriosis indication is a key priority for ObsEva. And the EDELWEISS 3 trial in the EU is progressing as planned with primary endpoint data expected in Q4 2021. And the ongoing Phase 3 EDELWEISS 3 study will enroll approximately 450 patients with endometriosis associated pain with a co-primary endpoint of response on both dysmenorrhea (menstrual pain) and non-menstrual pelvic pain.
The study includes a 75 mg once daily dose without hormonal ABT, and a 200 mg once daily dose in combination with hormonal ABT (1mg E2 / 0.5mg NETA). The data from the primary endpoint readout are expected in Q4 2021.
Investors have taken an interest in this news along with the slides provided by the company as it participated in the JPMorgan Healthcare Conference. And many investors recommended the stock on various platforms including YouTube and StockTwits. As a result, over 142 million shares of the company were traded on January 15 alone — which is well above the 1.74 million volume over a 30-day average.
“We are very pleased that the EMA has validated our application for Yselty, a potential best-in-class treatment for women suffering from heavy menstrual bleeding associated with uterine fibroids. Yselty is the only GnRH antagonist to provide flexible dosing options that will allow us to better address the individual needs of the diverse population of women with uterine fibroids. This marks a major milestone in making Yselty available in the E.U., and we look forward to working closely with the EMA as we advance Yselty towards commercialization. We also remain on track to submit the US NDA during the first half of 2021, a key objective for the company this year.”
— Elizabeth Garner, M.D., M.P.H., Chief Medical Officer of ObsEva
“After careful consideration, we strongly believe halting the EDELWEISS 2 study is the right decision for ObsEva, given the ongoing enrollment challenges. This decision also gives us the ability to conserve over $30 million. We remain fully committed to developing and commercializing Yselty in both uterine fibroids and endometriosis and are continuing to explore partnership and other financing opportunities to support the program. We also plan to conduct, as soon as is feasible, a new Phase 3 endometriosis study with a number of design and operational changes to facilitate faster enrollment, with a goal to maintain the original MAA and NDA filing timelines for this important indication. In addition, this cost-efficient approach will also help ObsEva progress our other pipeline programs, including ebopiprant, which recently yielded positive Phase 2 results in the treatment of preterm labor. We are also considering and planning for the potential development of linzagolix in prostate cancer, possibly in combination with estrogen add-back, a known approach to lowering side effects of androgen deprivation therapy. Overall, our strategy to more efficiently complete the development of the endometriosis indication development while improving utilization of capital will support our clinical development strategy and bring us another step closer to addressing unmet needs in women’s reproductive health.”
— Brian O’Callaghan, CEO of ObsEva
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