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    OBSV   CH0346177709


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Press Release: ObsEva Announces Enrollment Completion of Linzagolix Phase 3 EDELWEISS 3 Trial for Patients with Moderate to Severe Endometriosis-Associated Pain

05/04/2021 | 01:00am EDT
   - EDELWEISS 3 trial of Yselty(R) expected to report topline data as 
planned in Q4:21- 
   GENEVA, Switzerland and BOSTON, MA -- May 4, 2021 -- ObsEva SA (NASDAQ: 
OBSV) (SIX: OBSN), a biopharmaceutical company developing and 
commercializing novel therapies to improve women's reproductive health, 
today announced that it has completed enrollment for the Phase 3 
EDELWEISS 3 trial of Yeslty(R) for patients with moderate to severe 
endometriosis-associated pain (EAP). Enrollment completion is an 
important milestone, and data from the primary endpoint readout are 
expected in Q4 2021. 
   "Endometriosis is an emotionally and physically painful condition that 
affects approximately 176 million women worldwide and can be 
debilitating for many women. We continue to be in need of alternative 
treatment options that improve quality of life," said Jacques Donnez, 
M.D., Ph.D., Distinguished Professor of Obstetrics and Gynecology at the 
Catholic University of Louvain, Belgium. "The Phase 2b EDELWEISS data 
underscored Yselty's potential to address this critical unmet need while 
offering unique dosing options. Importantly, linzagolix 75mg dose 
significantly improved EAP symptoms at 12 weeks and these effects were 
maintained or increased at 24 weeks and 52 weeks, without clinically 
relevant decreases in bone mineral density. This is particularly 
encouraging, and I look forward to seeing additional informative data 
from the EDELWEISS 3 trial." 
   EDELWEISS 3 (Europe and the US) is a randomized, double-blind, 
placebo-controlled, Phase 3 trial that enrolled 486 women with moderate 
to severe EAP. The study is designed to evaluate the long-term efficacy 
and safety of Yselty, with a co-primary endpoint of reduction in both 
dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at Month 3, 
along with stable or decreased use of analgesics for EAP. The study 
includes a 75 mg once-daily dose without hormonal ABT (1 mg estradiol / 
0.5mg norethindrone acetate), and a 200 mg once-daily dose in 
combination with ABT. Subjects who complete the initial six-month 
treatment period will have the option to enter a six-month treatment 
extension, followed by a post-treatment follow-up. Additional 
information about this study can be found h 
   "The clinical development of Yselty for our endometriosis indication is 
a key priority for ObsEva, and we are pleased that the pivotal Phase 3 
EDELWEISS 3 trial has continued to progress as planned," said Brian 
O'Callaghan, CEO of ObsEva. "This milestone reflects significant 
progress and builds on the encouraging data from our Phase 2b trial, 
which demonstrated sustained improvement in overall endometriosis 
symptoms. With enrollment now completed for our Phase 3 trial, we are 
one step closer to providing women with better long-term treatment 
options. We will continue to build on this momentum and look forward to 
sharing top-line results later this year." 
   About Yselty(R) 
   Yselty(R) (linzagolix) is a novel, oral, once daily, GnRH receptor 
antagonist with a potentially best-in-class profile. Yselty 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 Yselty from Kissei in late 2015 and 
retains worldwide commercial rights, excluding Asia, for the product. 
   Yselty(R) is a registered trademark owned by Kissei for use by ObsEva. 
Yselty(R) is not yet approved for use anywhere in the world. 
   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 other similar expressions, and 
are based on ObsEva's current beliefs and expectations. These 
forward-looking statements include expectations regarding the potential 
therapeutic benefits and the clinical development of ObsEva's product 
candidates, the potential for new indications for  any of ObsEva's 
product candidates, the timing of enrollment in and data from clinical 
trials, expectations regarding regulatory and development milestones, 
including the potential timing of regulatory submissions to the EMA and 
FDA, the timing of and ObsEva's ability to obtain and maintain 
regulatory approvals for its product candidates, the results of 
interactions with regulatory authorities and the potential to raise 
additional funds or enter into strategic partnerships in the future. 
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, 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 
   +41 22 552 1550 
   Investor Contact: 
   Joyce Allaire 
   +1 (617)-435-6602 
   -- Press Release in Pdf 

(END) Dow Jones Newswires

May 04, 2021 01:00 ET (05:00 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
DJ INDUSTRIAL 1.06% 34382.13 Delayed Quote.9.74%
NASDAQ COMP. 2.32% 13429.978403 Delayed Quote.1.84%
OBSEVA SA 3.80% 2.73 Delayed Quote.26.44%
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More news
Financials (USD)
Sales 2021 0,00 M - -
Net income 2021 -85,1 M - -
Net cash 2021 30,7 M - -
P/E ratio 2021 -2,59x
Yield 2021 -
Capitalization 218 M 218 M -
EV / Sales 2021 62 600x
EV / Sales 2022 10,7x
Nbr of Employees 43
Free-Float 86,4%
Duration : Period :
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Technical analysis trends OBSEVA SA
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 3
Average target price 20,50 $
Last Close Price 2,73 $
Spread / Highest target 779%
Spread / Average Target 651%
Spread / Lowest Target 523%
EPS Revisions
Managers and Directors
Brian O'Callaghan Chief Executive Officer
David Renas Chief Financial Officer
Frank A. G. M. Verwiel Chairman
Jean-Pierre Gotteland Chief Scientific Officer, Head-R&D
Elizabeth Ijeoma Onyemelukwe Garner Chief Medical Officer
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