ObsEva Announces Symposium and Presentation of Clinical Data on Oral GnRH Antagonist Linzagolix at SEUD Congress 2021

Rhea-AI Summary

ObsEva SA (NASDAQ: OBSV) announced its participation in the 7th SEUD Congress on December 2, 2021. The company will feature a symposium focusing on linzagolix, an oral GnRH antagonist, scheduled for December 10, 2021. Key presentations include results from a Phase 2b trial on Bone Mineral Density recovery in women with endometriosis and Phase 3 trial results on the efficacy and safety of linzagolix for heavy menstrual bleeding due to uterine fibroids. These presentations aim to highlight the potential benefits of linzagolix in addressing unmet needs in women's health.

Positive

• Upcoming symposium on linzagolix at SEUD Congress may enhance visibility.
• Presentation details highlight ongoing clinical research and potential efficacy of linzagolix.

Negative

• Uncertainty remains regarding FDA's assessment of linzagolix's clinical data.
• Risks associated with clinical trials may affect future development timelines.

GENEVA, Switzerland December 2, 2021 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced a symposium and three oral presentations on linzagolix, an oral GnRH antagonist, at the 7th Society of Endometriosis and Uterine Disorders (SEUD) Congress being held virtually and in Stockholm, Sweden as a hybrid event from December 9-11, 2021.

During SEUD, ObsEva will host a live symposium entitled, “The potential of the oral GnRH antagonist: a personalized approach for women with uterine fibroids,” chaired by Professor Charles Chapron on Friday, December 10, 2021, at 1:00 p.m. CET.

 

Presentation details are as follows:

Title: Recovery of Bone Mineral Density (BMD) after Long Term Treatment with Linzagolix in Women with Endometriosis: Results from a Phase 2b Dose-Ranging Trial

• Format: Oral Presentation
• Presenter: Jacques Donnez
• Session Date & Time: Free Communications 1 beginning Friday, December 10^th at 4:30 p.m. CET
  
  

Title: Long Term Efficacy of Linzagolix for Treatment of Heavy Menstrual Bleeding (HMB) due to Uterine Fibroids (UF): 52-Week Results from Two Placebo-Controlled, Randomized, Phase 3 Trials

• Format: Oral Presentation
• Presenter: Hugh Taylor
• Session Date & Time: Free Communications 6 beginning Friday, December 10^th at 5:30 p.m. CET
  
  

Title: Long Term Safety and Tolerability of Linzagolix for Treatment of Heavy Menstrual Bleeding (HMB) due to Uterine Fibroids (UF): 52-Week Results from Two Placebo-Controlled, Randomized, Phase 3 Trials

• Format: Oral Presentation
• Presenter: Jacques Donnez
• Session Date & Time: Free Communications 6 beginning Friday, December 10^th at 5:30 p.m. CET
  
  

 

About ObsEva
Obseva is a biopharmaceutical company built to address some of the most challenging unmet needs in women’s health – an under-researched, under-invested field of medicine. With deep expertise in clinical development, Obseva is passionate about the pursuit of advances that benefit women and their health and the importance of delivering truly meaningful innovation in this space. Through strategic in-licensing and disciplined drug development, Obseva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. Obseva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

Cautionary Note Regarding Forward Looking Statements of ObsEva SA

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 and potential therapeutic and clinical benefits of and commercialization plans for Obseva’s product candidates, including linzagolix, expectations regarding regulatory and development milestones, including the potential timing of and Obseva’s ability to obtain and maintain regulatory approvals for its product candidates, and the results of interactions with regulatory authorities, including the FDA and EMA. 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 that FDA’s review of the linzagolix NDA may determine that the existing clinical data is insufficient to support approval or that significant labeling limitations would be required, 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, and the capabilities of such third parties; the impact of the ongoing 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 filed with Securities and Exchange Commission (SEC) on March 5, 2021 and in the Report on Form 6-K filed with the SEC on November 4, 2021, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of Obseva’s website at 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

Investor Contact
Joyce Allaire
jallaire@lifesciadvisors.com
+1 (617) 435-6602

 

 

 

Attachment

• Press Release in Pdf

FAQ

What is the purpose of ObsEva's symposium at the SEUD Congress?

The symposium focuses on the potential of linzagolix as a personalized treatment for women with uterine fibroids.

What are the key presentations about linzagolix at the SEUD Congress?

Key presentations include results from a Phase 2b trial on Bone Mineral Density recovery and Phase 3 trial results on efficacy and safety for treating heavy menstrual bleeding.

What are the implications of linzagolix's trial results for ObsEva's market performance?

Positive trial results could boost investor confidence and enhance the company's market position in women's health.

When will the oral presentations on linzagolix take place during the SEUD Congress?

The oral presentations are scheduled for December 10, 2021, starting at 4:30 p.m. CET.