OBSV ObsEva SA

2.7
+0.02  (+1%)
Previous Close 2.68
Open 2.84
52 Week Low 1.63
52 Week High 10.3504
Market Cap $129,596,728
Shares 47,998,788
Float 35,122,621
Enterprise Value $122,654,448
Volume 445,847
Av. Daily Volume 1,126,503
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Upcoming Catalysts

Drug Stage Catalyst Date
OBE022 - PROLONG
Pre-term labor
Phase 2a
Phase 2a
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Linzagolix OBE2109 - PRIMROSE 2
Uterine fibroids
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
Linzagolix (OBE2109) - EDELWEISS 3
Endometriosis
Phase 3
Phase 3
Phase 3 initiation announced May 9, 2019. Enrollment has resumed following pause due to COVID-19.
Linzagolix (OBE2109)- EDELWEISS 2
Endometriosis
Phase 3
Phase 3
Phase 3 initiation announced May 9, 2019. Enrollment has resumed following pause due to COVID-19.
Linzagolix OBE2109 - PRIMROSE 1
Uterine fibroids
Phase 3
Phase 3
Phase 3 data trial met primary endpoint - July 6, 2020. Placebo adjusted rates lower than competition.
Nolasiban (OBE001) - IMPLANT 4
Improving IVF outcomes
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - November 10, 2019.
OBE001 - IMPLANT2
IVF
Phase 3
Phase 3
Phase 3 data released February 26,2018 - primary endpoint met. Improvement shown in ET D5 subgroup but not in ET D3.

Latest News

  1.  

    Geneva, Switzerland and Boston, MA –  August 7, 2020 – ObsEva SA (NASDAQ:OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced that CEO Ernest Loumaye will present an update on the Company and its pipeline at the Wedbush PacGrow Virtual Healthcare Conference taking place August 11 - 12, 2020.

    Mr. Loumaye's presentation will take place on Wednesday August 12, 2020 at 9:45 a.m. Eastern Time (ET).  A live presentation link will be available under "Events Calendar" in the investors section of ObsEva's website at www.ObsEva.com

     

    About ObsEva

    ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve…

     

    Geneva, Switzerland and Boston, MA –  August 7, 2020 – ObsEva SA (NASDAQ:OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced that CEO Ernest Loumaye will present an update on the Company and its pipeline at the Wedbush PacGrow Virtual Healthcare Conference taking place August 11 - 12, 2020.

    Mr. Loumaye's presentation will take place on Wednesday August 12, 2020 at 9:45 a.m. Eastern Time (ET).  A live presentation link will be available under "Events Calendar" in the investors section of ObsEva's website at www.ObsEva.com

     

    About ObsEva

    ObsEva 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.

     

    For further information, please contact:

     

    CEO Office contact

    Shauna Dillon

    obseva.ch

    +41 22 552 1550

    Investor Contact

    Mario Corso

    Vice President, Investor Relations

    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

     

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  2.  

    • Primary endpoint successfully met in Phase 3 PRIMROSE 1 trial of linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids
    • Phase 3 data from PRIMROSE 2 trial demonstrated sustained efficacy and continued safety over 52 weeks of treatment with linzagolix,including bone mineral density changes   
    • Phase 3 trial results support the advancement of linzagolix 100 mg without add-back therapy and 200 mg with add-back therapy doses to regulatory submissions planned for Q4:20/H1:21 in Europe/U.S.
    • Actively discussing commercial partnership to maximize linzagolix best-in-class potential
    • OBE022 Phase 2 PROLONG trial results on track for Q4:20
    • YuYuan Bioscience Technology submitted pre-IND meeting request for nolasiban development in

     

    • Primary endpoint successfully met in Phase 3 PRIMROSE 1 trial of linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids
    • Phase 3 data from PRIMROSE 2 trial demonstrated sustained efficacy and continued safety over 52 weeks of treatment with linzagolix,including bone mineral density changes   
    • Phase 3 trial results support the advancement of linzagolix 100 mg without add-back therapy and 200 mg with add-back therapy doses to regulatory submissions planned for Q4:20/H1:21 in Europe/U.S.
    • Actively discussing commercial partnership to maximize linzagolix best-in-class potential
    • OBE022 Phase 2 PROLONG trial results on track for Q4:20
    • YuYuan Bioscience Technology submitted pre-IND meeting request for nolasiban development in China  

                           

    GENEVA, Switzerland and BOSTON, MA (August 6, 2020) – ObsEva SA (NASDAQ:OBSV) (SIX: OBSN), a late clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today reported financial results for the quarter ended June 30, 2020 and provided a business update.

    "The excellent phase 3 results from PRIMROSE 1 and PRIMROSE 2 last month were critical achievements as we now embark upon regulatory filings and commercial preparation", said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. "We strongly believe that our strategy to develop both a low dose of linzagolix without hormonal add back therapy and a high dose with hormonal add back therapy is the optimal way to treat more women suffering from heavy menstrual bleeding due to uterine fibroids."

     

    Pipeline Update

     

    Linzagolix for the treatment of uterine fibroids and endometriosis

    • Positive Phase 3 results for PRIMROSE 1 and PRIMROSE 2 trials of linzagolix for the treatment of HMB due to uterine fibroids:  PRIMROSE 1 is being conducted in approximately 500 women experiencing heavy menstrual bleeding (HMB) due to uterine fibroids. As announced July 6, 2020, the 24-week responder rate was 75.5% for women receiving 200mg linzagolix and add back therapy (ABT) and 56.4% for women receiving 100 mg linzagolix without ABT, vs. 35.0% for placebo (p<0.001 and p=0.003 respectively).  In addition, 52-week data from PRIMROSE 2 demonstrate that continued treatment with linzagolix provides sustained efficacy and is well tolerated. Responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively, both of which are similar to the responder rates observed at week 24 of the study. The pooled week 24 data from these two Phase 3 studies support a potentially best-in-class profile, with a responder rate of 84.7% in women receiving linzagolix 200 mg with ABT, and 56.6% in women receiving linzagolix 100 mg without ABT.

       
    • New patient enrollment in Phase 3 trials EDELWEISS 2 (U.S.) and EDELWEISS 3 (U.S. and Europe) resuming:  Following the decision to temporarily stop enrolling new patients due to the COVID-19 pandemic announced in March 2020, the EDELWEISS 2 and 3 trials resumed enrollment of new patients in the latter part of the second quarter.  Each of these trials is designed to assess two once daily oral doses of linzagolix in women with endometriosis-associated pain, including 75mg without ABT and 200mg with ABT.

       
    • Linzagolix commercial partnership: ObsEva is engaged in active discussions with several parties for a commercial partnership to maximize the best-in-class potential of linzagolix.

     

    OBE022 to delay childbirth in pregnant women with preterm labor at 24-34 weeks of gestation

    • Enrollment completed in Phase 2 PROLONG part B: Part B is the multicenter, randomized, double-blind, placebo-controlled portion of the PROLONG trial that enrolled up to 120 women with preterm labor at a gestational age between 24 and 34 weeks. Enrollment in Part B was completed in March 2020, and infant delivery and follow-up is ongoing.

     

    Nolasiban for improving pregnancy and live birth in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF)

    • Nolasiban partnership with YuYuan BioScience Technology (YuYuan) for development and commercialization in China:  On July 1, 2020, ObsEva and YuYuan announced a pre-IND meeting request to the Chinese National Medical Products Administration (NMPA) to enable a Phase 1 and Phase 2 proof of concept study in China. 

     

    Anticipated Milestones

    ObsEva expects to achieve the following clinical and regulatory milestones in 2020-21:

     

    Fourth Quarter 2020

    • Linzagolix: Pending feedback from national authorities, submit a Marketing Authorization Application (MAA) in Europe through a centralized procedure for the uterine fibroid indication.
    • OBE022: Report final safety and efficacy results from the PROLONG trial encompassing maternal and neonatal follow-up.
    • Nolasiban: Investigational new drug (IND) submission in China by YuYuan Bioscience Technology to initiate clinical development.

     

    First Half 2021

    • Linzagolix: Complete safety follow-up, and submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for the uterine fibroid indication.    

     

    Second Quarter 2020 Financial Results

    Net loss for the quarter ending June 30, 2020 was $18.2 million, or $0.38 per share, compared with a net loss of $34.8 million, or $0.80 per share, for the quarter ending June 30, 2019.  Research and development expenses were $15.4 million and general and administrative expenses were $2.2 million for the quarter, compared with $28.4 million and $6.2 million, respectively, for the prior year quarter.  The net loss for the quarter included non-cash expenses of $1.4 million for stock-based compensation, compared with $3.1 million a year ago.   

    As of June 30, 2020, ObsEva had cash and cash equivalents of $45.0 million, compared with $69.4 million as of December 31, 2019.

    The half-year report 2020 will be available in the financial reports section of the Company's website.

    To access the financial reports section of the Company's website, please click [here].

    To access the half-year report 2020 directly, please click [here].

     

    About ObsEva

    ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a 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 IVF outcomes. 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.

     

    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, the potential therapeutic benefits of such product candidates, the timing of enrollment in and data from clinical trials, including the impact of the COVID-19 pandemic on such trials, ObsEva's plan to submit its MAA in Europe and NDA in the United States, YuYuan's submission of an investigational new drug application in China, the results of interactions with regulatory authorities and ObsEva's ability to enter into a future commercial partnership for linzagolix. 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 effects of the COVID-19 pandemic, any benefits from the joint collaboration with YuYuan or any future commercial partnership for linzagolix may not be fully realized or may take longer to realize than expected 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, 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



    +41 22 552 1550

    Investor Contact:

    Mario Corso

    Vice President, Investor Relations



    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

     

    Consolidated Statements of Comprehensive Loss

       Three-Month Period

    Ended June 30
      Six-Month Period

    Ended June 30
     
    (in USD '000, except share and per share data) - unaudited 2020  2019  2020  2019 
    Operating income other than revenue  4   1   8   6 
    OPERATING EXPENSES                
    Research and development expenses  (15,377)  (28,438)  (32,565)  (48,578)
    General and administrative expenses  (2,191)  (6,186)  (5,900)  (11,441)
    Total operating expenses  (17,568)  (34,624)  (38,465)  (60,019)
    OPERATING LOSS  (17,564)  (34,623)  (38,457)  (60,013)
    Finance income  48   (56)  108   206 
    Finance expense  (690)  (43)  (1,701)  (587)
    NET LOSS BEFORE TAX  (18,206)  (34,722)  (40,050)  (60,394)
    Income tax benefit / (expense)  38   (34)  19   (41)
    NET LOSS FOR THE PERIOD  (18,168)  (34,756)  (40,031)  (60,435)
    Net loss per share                
    Basic  (0.38)   (0.80)   (0.86)   (1.39)
    Diluted  (0.38)   (0.80)   (0.86)   (1.39)
    Weighted Average Number of Shares Outstanding  47,709,508   43,555,963   46,717,535   43,532,815 
                     
                     
                     

     

    Consolidated Balance Sheets

    (in USD '000)  June 30,

    2020
      December 31,

    2019
     
    ASSETS         
    Current assets         
    Cash and cash equivalents   44,965   69,370 
    Other receivables   314   1,044 
    Prepaid expenses   5,105   4,359 
    Total current assets   50,384   74,773 
    Non-current assets         
    Right-of-use assets   1,734   2,042 
    Furniture, fixtures and equipment   194   245 
    Intangible assets   26,608   26,608 
    Other long-term assets   278   275 
    Total non-current assets   28,814   29,170 
    Total assets   79,198   103,943 
    LIABILITIES AND SHAREHOLDERS' EQUITY         
    Current liabilities         
    Other payables and current liabilities   12,172   8,432 
    Accrued expenses   7,171   10,418 
    Current lease liabilities   642   618 
    Total current liabilities   19,985   19,468 
    Non-current liabilities         
    Non-current lease liabilities   1,232   1,541 
    Non-current borrowings   25,109   24,917 
    Post-employment obligations   8,059   7,946 
    Other long-term liabilities   1,133   1,116 
    Total non-current liabilities   35,533   35,520 
    Shareholders' equity         
    Share capital   3,781   3,499 
    Share premium   332,566   320,955 
    Reserves   24,775   21,912 
    Accumulated losses   (337,442)  (297,411)
    Total shareholders' equity   23,680   48,955 
    Total liabilities and shareholders' equity   79,198   103,943 

    ###

     

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  3.  

    Geneva, Switzerland and Boston, MA – July 15, 2020 – ObsEva SA (NASDAQ:OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced winning the Clinical Science Award for Oral Presentation at the ESHRE Virtual 36th Annual Meeting, which took place July  5-8, 2020. The Award was presented to the first and presenting author of the best oral presentation on a clinical science topic.

    Dr Hugh Taylor, presented on Monday, July 6th, from 11:00 - 11:10 CEST in Session 05

    Presentation number: O-190 

    Efficacy and safety of linzagolix on heavy menstrual bleeding (HMB) due to uterine fibroids (UF): Results from a placebo-controlled, randomized, Phase 3…

     

    Geneva, Switzerland and Boston, MA – July 15, 2020 – ObsEva SA (NASDAQ:OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced winning the Clinical Science Award for Oral Presentation at the ESHRE Virtual 36th Annual Meeting, which took place July  5-8, 2020. The Award was presented to the first and presenting author of the best oral presentation on a clinical science topic.

    Dr Hugh Taylor, presented on Monday, July 6th, from 11:00 - 11:10 CEST in Session 05

    Presentation number: O-190 

    Efficacy and safety of linzagolix on heavy menstrual bleeding (HMB) due to uterine fibroids (UF): Results from a placebo-controlled, randomized, Phase 3 trial

    The link for the presentation on the ESHRE platform, is available under "Events Calendar" (past events) in the investors section of ObsEva's website at www.ObsEva.com

     

    About ObsEva

    ObsEva 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 Linzagolix

    Linzagolix is a novel, once daily, oral 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 Kissei

    Kissei 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.

     

    For further information, please contact:

    CEO Office contact

    Shauna Dillon

    obseva.ch

    +41 22 552 1550

    Investor Contact

    Mario Corso

    Vice President, Investor Relations

    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

     

     

     

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  4.  

    • PRIMROSE 1 achieved statistically significant and clinically meaningful results across primary and key secondary endpoints at week 24 
    • PRIMROSE 2 results demonstrate sustained efficacy and continued safety of linzagolix at week 52
       
    • Results confirm linzagolix as a potential best-in-class GnRH antagonist, with a pooled responder rate of 84.7% for the 200 mg with Add Back Therapy* (ABT) dose from PRIMROSE 1 and 2
       
    • Linzagolix is the only GnRH antagonist as a potential unique treatment option for up to 50% of US women with uterine fibroids for whom ABT therapy may be contraindicated
       
    • Success of PRIMROSE 1 and 2 studies enables progression towards regulatory submissions, anticipated 4Q 2020 in the EU and 1H 2021 in the US

     

    GENEVA, Switzerland

     

    • PRIMROSE 1 achieved statistically significant and clinically meaningful results across primary and key secondary endpoints at week 24 
    • PRIMROSE 2 results demonstrate sustained efficacy and continued safety of linzagolix at week 52

       
    • Results confirm linzagolix as a potential best-in-class GnRH antagonist, with a pooled responder rate of 84.7% for the 200 mg with Add Back Therapy* (ABT) dose from PRIMROSE 1 and 2

       
    • Linzagolix is the only GnRH antagonist as a potential unique treatment option for up to 50% of US women with uterine fibroids for whom ABT therapy may be contraindicated

       
    • Success of PRIMROSE 1 and 2 studies enables progression towards regulatory submissions, anticipated 4Q 2020 in the EU and 1H 2021 in the US

     

    GENEVA, Switzerland and BOSTON, MA (July 6, 2020) – ObsEva SA (NASDAQ:OBSV, SIX: OBSN))), a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced top-line results from the PRIMROSE 1 and 2 studies of Yselty® (linzagolix) to assess the efficacy and safety in women with heavy menstrual bleeding due to uterine fibroids.

    PRIMROSE 1 met the primary endpoint at week 24, and showed that women receiving linzagolix experienced a statistically significant and clinically meaningful reduction in menstrual blood loss (≤80 mL and a ≥50% reduction from baseline) compared to placebo. Women receiving 200 mg with ABT achieved a 75.5% (P<0.001) responder rate and those receiving 100 mg without ABT achieved a 56.4% (P=0.003) responder rate. 

    The pooled week 24 data from these two Phase 3 studies support a best-in-class profile, with a responder rate of 84.7% in women receiving linzagolix 200 mg with ABT, and 56.6% in women receiving linzagolix 100 mg without ABT.

    In addition, new data from PRIMROSE 2 demonstrate that continued treatment with linzagolix for 52 weeks provides sustained efficacy and is well tolerated. Responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively, both of which are similar to the responder rates observed at week 24 of the study.

    Across both studies, women receiving linzagolix experienced statistically significant improvements across a number of clinically relevant secondary endpoints, including reduction in pain, improvement in anemia and quality of life.

    "We are extremely pleased by the overall performance of Yselty in addressing heavy menstrual bleeding, a major symptom of uterine fibroids. These data definitively confirm our belief that Yselty, with and without add-back therapy, has the potential to be an effective treatment for addressing the broad needs of women suffering from uterine fibroids," said Dr. Ernest Loumaye, ObsEva CEO and cofounder. "Yselty's unique and differentiated profile reinforces its potential as a promising, commercially competitive product, designed to offer more women a treatment adapted to their clinical and personal needs. These excellent data move us closer to the potential commercialization of Yselty and our immediate priority is to progress our regulatory filings."

    In PRIMROSE 1, the incidence of adverse events was similar between placebo and active treatment. The most frequently observed adverse events, with an incidence >5%, were headache and hot flushes. In addition, a minimal mean percentage change in lumbar spine bone mineral density (BMD) from baseline was observed in both treatment arms at week 24.

    In PRIMROSE 2, the most frequently observed adverse events, with an incidence >5%, were headache, hot flushes and anemia. In addition, a small incremental change in BMD was observed at week 52 compared to week 24.

    "Women with symptomatic uterine fibroids experience debilitating pain and discomfort from heavy menstrual bleeding, which often becomes progressively worse, impacting work, home life, and importantly, a woman's overall health and well-being," said Dr. Hugh Taylor, Professor at Yale School of Medicine, U.S. "New and effective treatment options that provide long lasting symptom relief are needed for women with uterine fibroids, including for the significant number of women who cannot receive, or wish to avoid, hormone replacement therapy. I am very pleased to see these results, which demonstrate that both regimens of linzagolix are effective in controlling bleeding, reducing fibroid related pain and improving anemia. This could provide a long-awaited medical treatment option to address current unmet needs."

    ObsEva is now preparing its regulatory submissions to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) which it anticipates submitting in 4Q 2020 and 1H 2021, respectively. Data from across the clinical trial program will be submitted for presentation at upcoming scientific conferences.

    Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in the world. 

     

    * Add Back Therapy = 1 mg estradiol and 0.5 mg norethindrone acetate daily

     

    Conference Call and Webcast Today

    ObsEva will host a conference call and audio webcast today beginning at 8:00 a.m. Eastern Time / 2:00 p.m. Central European Time to discuss Phase 3 PRIMROSE 1 & 2 study results of linzagolix. Investors may participate by dialing (844) 419-1772 for U.S. callers or +1 (213) 660-0921 for international callers, and referring to conference ID 6673575. A live or archived webcast of the conference call can be accessed via the following link: https://www.obseva.com/event-detail/?event=3249.

     

    About Linzagolix

    Yselty® (linzagolix) is a novel, once daily, oral 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. Linzagolix is not currently approved anywhere in the world.

     

    About Phase 3 PRIMROSE Program in Uterine Fibroids

    PRIMROSE 1 & 2 are prospective, randomized, parallel group, double-blind, placebo‑controlled Phase 3 studies investigating the efficacy and safety of two dosing regimens of linzagolix, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT for the treatment of heavy menstrual bleeding associated with uterine fibroids. Women participating in the study did not receive Vitamin D or calcium supplementation. PRIMROSE 1 is being conducted in the US and enrolled 526 women; PRIMROSE 2 is being conducted in Europe and the US and enrolled 535 women. Both trials comprised a 52 week treatment period followed by a 6-month post treatment follow-up period. Week 24 primary endpoint results were announced for PRIMROSE 2 in December 2019.

     

    About Uterine Fibroids

    Uterine fibroids is a common condition that consists of the growth of benign tumours of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to a large bulky mass. 

    The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.

     

    About ObsEva

    ObsEva 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 and preterm labor. 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 Kissei

    Kissei 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 clinical development of ObsEva's product candidates, including the timing, advancement and potential therapeutic benefits of linzagolix, the potential for linzagolix to be a commercially competitive product, the timing of data from clinical trials, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the EMA and 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 May 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

    obseva.ch

    +41 22 552 1550

    Investor Contact

    Mario Corso

    Vice President, Investor Relations



    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

     

     

     

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  5.  

    Geneva, Switzerland and Boston, MA – July 3, 2020 – ObsEva SA (NASDAQ:OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced that they will present at ESHRE Virtual 36th Annual Meeting, taking place July  5-8, 2020.

     

    Dr Hugh Taylor, to present on Monday, July 6th, from 11:00 - 11:10 CEST in Session 05

    Presentation number: O-190 (pre-selected for Clinical Science Award for Oral Presentation and for the Fertility Society of Australia Exchange Award)

    Efficacy and safety of linzagolix on heavy menstrual bleeding (HMB) due to uterine fibroids (UF): Results from a placebo-controlled, randomized, Phase 3 trial

     

    Dr Oliver Pohl, to present…

     

    Geneva, Switzerland and Boston, MA – July 3, 2020 – ObsEva SA (NASDAQ:OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced that they will present at ESHRE Virtual 36th Annual Meeting, taking place July  5-8, 2020.

     

    Dr Hugh Taylor, to present on Monday, July 6th, from 11:00 - 11:10 CEST in Session 05

    Presentation number: O-190 (pre-selected for Clinical Science Award for Oral Presentation and for the Fertility Society of Australia Exchange Award)

    Efficacy and safety of linzagolix on heavy menstrual bleeding (HMB) due to uterine fibroids (UF): Results from a placebo-controlled, randomized, Phase 3 trial

     

    Dr Oliver Pohl, to present on Tuesday, July 7th, from 15:25 - 15:35 CEST in Session 48

    Presentation number: O-027 

    The mechanism of action of oxytocin receptor antagonists (OTRan) in ART – a study of nolasiban on biomarkers of uterine receptivity in healthy female volunteers

     

    The link for both presentations on the ESHRE platform, will be available under "Events Calendar" in the investors section of ObsEva's website at www.ObsEva.com

     

    About ObsEva

    ObsEva 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.

     

    For further information, please contact:

     

    CEO Office contact

    Shauna Dillon

    obseva.ch

    +41 22 552 1550

    Investor Contact

    Mario Corso

    Vice President, Investor Relations

    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

     

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