MARKET

OBSV

OBSV

Obseva
NASDAQ

Real-time Quotes | Nasdaq Last Sale

2.040
-0.110
-5.12%
Pre Market: 2.080 +0.04 +1.96% 06:11 12/04 EST
OPEN
2.150
PREV CLOSE
2.150
HIGH
2.155
LOW
2.020
VOLUME
72.96K
TURNOVER
--
52 WEEK HIGH
6.30
52 WEEK LOW
1.630
MARKET CAP
114.07M
P/E (TTM)
-1.1200
1D
5D
1M
3M
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5Y
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Is ObsEva SA (OBSV) A Good Stock To Buy Now?
We know that hedge funds generate strong, risk-adjusted returns over the long run, therefore imitating the picks that they are collectively bullish on can be a profitable strategy for retail investors. With billions of dollars in assets, smart money investors have to conduct complex analyses, spend many resources and use tools that are not always […]
Insider Monkey · 1d ago
ObsEva SA to present at The International Society of Gynecological Endocrinology 19th World Congress virtual edition, December 2-5, 2020
Geneva, Switzerland and Boston, MA – December 1, 2020 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health today announced that Ernest Loumaye, MD, PhD, co-founder and member of the Board of Directors, will give a presentation at the ISGE (International Society of Gynecological Endocrinology) 19th World Congress Virtual Edition, December 2-5, 2020. Dr Loumaye’s presentation will take place during the symposium available on demand on Friday December 4th from 08:00 am GMT and accessible for 4 months. The link to the Congress and sessions will be available under “Events Calendar” in the investors section of ObsEva’s website at www.ObsEva.comSymposium:      IVF AND PREGNANCY: Recent development in IVFDate:                Friday December 4thTitle:                The use of a novel oxytocin receptor antagonist, nolasiban, prior to embryo transfer: does it help? About ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving ET outcomes following IVF. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com. About Nolasiban Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist which was licensed from Merck KGaA, Darmstadt, Germany, in 2013. ObsEva retains worldwide, exclusive, commercial rights (ex China). Cautionary Note Regarding Forward Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, , ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.For further information, please contact: CEO Office contact Shauna Dillon Shauna.dillon@obseva.ch +41 22 552 1550    Attachment * Press Release in Pdf
GlobeNewswire · 3d ago
ObsEva (OBSV) Catches Eye: Stock Jumps 5.1%
ObsEva (OBSV) saw a big move last session, as its shares jumped more than 5% on the day, amid huge volumes.
Zacks · 3d ago
The Daily Biotech Pulse: Alnylam's Oxluma Snags Early FDA Approval, DBV Chief Scientific Officer To Depart, Decision Day For Liquidia
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Nov. 23)
Benzinga · 11/24 13:12
ObsEva submits marketing application for Yselty in Europe for uterine fibroids
ObsEva (OBSV) has submitted a Marketing Authorization Application ((MAA)) to the EMA for Yselty (linzagolix 100mg and 200mg) for the management of heavy menstrual bleeding ((HMB)) associated with uterine fibroids.
Seekingalpha · 11/24 06:41
ObsEva SA Submits Marketing Authorization Application to the European Medicines Agency for YSELTY(R) (linzagolix) for the Treatment of Women with Uterine Fibroids
Globe Newswire · 11/24 06:00
ObsEva SA Submits Marketing Authorization Application to the European Medicines Agency for YSELTY® (linzagolix) for the Treatment of Women with Uterine Fibroids
* If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options for the management of uterine fibroids: * 100 mg once daily for women with a contraindication to or who prefer to avoid hormonal add-back therapy (ABT) * 200 mg once daily with concomitant ABT for long-term use (beyond 6 months) * 200 mg once daily for short-term use, in particular when rapid reduction in fibroid volume is desired  * ObsEva expects to submit a new drug application to U.S. Food and Drug Administration in 1H:21             GENEVA, Switzerland and BOSTON, MA (November 24, 2020) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for YSELTY® (linzagolix 100mg and linzagolix 200mg) for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids.“The MAA submission is a major milestone for the company as it represents more than 5 years of drug development work by ObsEva team. I want to thanks all those who in the company or as subcontractors, as well as the more than 2,000 patients who contributed to this milestone. In developing multiple dose options, our long-term strategy has always been to meet the needs of the diverse population of women with uterine fibroids,” said Dr. Ernest Loumaye, founder and CEO of ObsEva. “Successful submission of the MAA brings us a step closer toward commercialization of Yselty, which will provide more women a potential best-in-class treatment for uterine fibroids.”The Phase 3 clinical program in uterine fibroids comprises two pivotal trials, PRIMROSE 1 and PRIMROSE 2, that were designed to demonstrate the effectiveness and safety to support the claimed indication: management of HMB associated with uterine fibroids. The application is being submitted at this time as both Phase 3 studies have met their success criteria: both low and high doses of linzagolix with and without ABT are effective in the treatment of HMB associated with uterine fibroids and have an acceptable benefit risk profile.The EMA is expected to notify ObsEva in December 2020 regarding the outcome of its validation of the MAA to ensure all essential regulatory elements required for a scientific assessment are included in the application prior to the start of the procedure.About LinzagolixLinzagolix (previously known as OBE2109) is a novel, oral, once daily, GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.About PRIMROSE 1 AND 2PRIMROSE 1 (conducted in the United States, which enrolled 574 women with uterine fibroids) and the PRIMROSE 2 (conducted in Europe and in the United States, which enrolled 535 women with uterine fibroids) clinical trials are two Phase 3 clinical trials of linzagolix in patients with HMB associated with uterine fibroids. In both trials, patients were administered linzagolix doses of 100 mg or 200mg, both with and without hormonal ABT, or placebo. The primary endpoint of both trials was reduction in HMB at 24 weeks; responders were defined as patients with menstrual blood loss (MBL) of ≤ 80 mL and a ≥ 50 percent reduction from baseline in MBL, measured using the alkaline hematin method. Secondary endpoints included amenorrhea, time to reduced MBL, hemoglobin (Hb), pain, and quality of life (QoL). Safety endpoints included bone mineral density (BMD), and adverse events (AEs). Calcium/vitamin D were not provided. BMD was measured centrally via Dual Energy X-ray Absorptiometry (DEXA) scan at baseline and 24, 52, and 76 weeks (6-month post treatment assessment).Both PRIMROSE trials successfully met the primary endpoint, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo. 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. Substantial improvements were also observed in all doses for the secondary endpoints of amenorrhea, time to reduced MBL and amenorrhea, hemoglobin levels in anemic subjects, pain, and quality of life.  The 200 mg dose alone showed rapid and substantial reduction in uterine and fibroid volume.In PRIMROSE 1, the responder rate was 75.5% (p 5% of patients) were headache and hot flushes. Mean percentage changes from baseline in BMD were minimal, as expected with any GnRH antagonist treatment.In PRIMROSE 2, the responder rate was 93.9% (p 5% of patients) were headache, hot flushes, and anemia. Mean percentage changes from baseline in BMD were minimal and consistent with previous clinical data. 52-week results demonstrated that continued treatment with linzagolix provided sustained efficacy in the reduction of HMB; responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively. In addition, small incremental changes in BMD were observed at week 52 compared to week 24, suggesting the onset of plateauing BMD loss.Additional follow-up data to be collected include PRIMROSE 1 52-week treatment results and 6-month post treatment assessment from both studies.About ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer outcomes following in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.About KisseiKissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.Cautionary Note Regarding Forward Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the timing, advancement, best-in-class efficacy and potential therapeutic benefits of linzagolix, the potential for linzagolix to be a commercially competitive product, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the FDA, and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. For further information, please contact: CEO Office contact Shauna Dillon Shauna.dillon@obseva.ch +41 22 552 1550   Attachment * Press Release in Pdf
GlobeNewswire · 11/24 06:00
What Type Of Shareholders Make Up ObsEva SA's (NASDAQ:OBSV) Share Registry?
A look at the shareholders of ObsEva SA (NASDAQ:OBSV) can tell us which group is most powerful. Generally speaking, as...
Simply Wall St. · 11/16 13:08
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Analyst Rating

Based on 7 analysts

Buy

Disclaimer: The analysis information is for reference only and does not constitute an investment recommendation.

Analyst Price Target
The average OBSV stock price target is 12.83 with a high estimate of 28.00 and a low estimate of 4.000.
EPS
Institutional Holdings
Institutions: 92
Institutional Holdings: 39.84M
% Owned: 71.26%
Shares Outstanding: 55.92M
TypeInstitutionsShares
Increased
13
710.18K
New
29
2.85M
Decreased
6
1.60M
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0
0
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No Data
Industry
Biotechnology & Medical Research
+2.41%
Pharmaceuticals & Medical Research
+0.49%
Key Executives
Chairman/Independent Director
Frank Verwiel
Director
Ernest Loumaye
Chief Scientific Officer
Jean-Pierre Gotteland
Other
Elizabeth Garner
Other
Wim Souverijns
Independent Director
Annette Clancy
Independent Director
Barbara Duncan
Independent Director
James Healy
Independent Director
Edward Mathers
Independent Director
Rafaele Tordjman
Independent Director
Jacky Vonderscher
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About OBSV
Obseva SA is a Switzerland-based company active in the pharmaceutical and medical research sector. The Company develops oral compounds to treat women’s reproductive health conditions from conception to birth. Its pipeline includes three product candidates: Linzagolix (OBE2109), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist intended for the treatment of endometriosis (phase 2b of clinical trials) and uterine fibroids (phase 3 of clinical trials); Nolasiban (OBE001), an oral oxytocin receptor antagonist undergoing phase 3 of clinical trials, with the potential to inhibit uterine contractions at the time of embryo transfer, thereby enhancing embryo implantation during assisted reproductive technologies (ART), and OBE022, an oral and selective prostaglandin F2 alpha (PGF2a) receptor antagonist designed to control preterm labor (phase 2a of clinical trials).
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