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Tag: ObsEva

  • EDELWEISS 3 Trial Positive Topline Results: ObsEva S.A. (OBSV) stock Hikes Premarket

    On January 06, ObsEva S.A. (OBSV) reported positive topline results from its Phase 3 EDELWEISS 3 Trial in endometriosis-associated pain (EAP). Consequently, the stock was trading at $2.21 apiece in the premarket at the last check.

    In the previous trading session on Wednesday, the stock lost 3.29% at its closing price of $2.06. Following the news, OBSV had gained 7.28% at the time of writing.

    The clinical-stage biopharmaceutical company, ObsEva S.A. has a market capitalization of $181.52 million with its 85.22 million shares outstanding.

    Phase 3 EDELWEISS 3 Trial

    The company has been conducting the Phase 3 Edelweiss 3 trial of linzagolix in women with moderate-to-severe EAP. The double-blind, placebo-controlled trial analyzed 484 women in Europe and the U.S. Further, the trial was designed to test the efficacy and safety of linzagolix in long term. Moreover, the study tested two doses of linzagolix; a 200 mg once-daily dose in combination with add-back therapy (ABT), and a 75 mg dose without ABT.

    Endometriosis is a reproductive organs disease of women associated with a chronic inflammatory reaction, pelvic pain, and many other discomforts and disruptions. Furthermore, linzagolix is OBSV’s oral GnRH receptor antagonist which has completed its clinical trial development for uterine-fibroids associated heavy bleeding.

    On January 06, the company announced positive topline data from the trial. According to the data the 200 mg dose:

    • At three months, it achieved co-primary efficacy objectives with reduced dysmenorrhea (DYS) and non-menstrual pelvic pains (NMPP) at 3 months.
    • The first five secondary endpoints also showed statistically significant and clinically meaningful improvements at 6 months.

    According to the 75 mg dose of linzagolix without ABT data:

    • Statistically significant reduction was demonstrated in DYS against the placebo at three months.
    • Did not reach co-primary efficacy objective but did show improvement in NMPP at three months.
    • Showed improvements in the first five secondary endpoints at six months like the 200 mg dose.

    In addition, both the doses demonstrated general well-tolerability with few adverse events.

    OBSV’s Other Developments

    Recently, the company announced its participation at the upcoming H.C. Wainwright BioConnect Conference. OBSV’s management will be providing the company’s corporate updates at the conference which is taking place from January 10 to 13, 2022.

    Previously, the company had announced its selection for addition to the NASDAQ Biotechnology Index (NBI). This addition was effective on Monday, December 20, 2021, at the opening of the market.

  • ObsEva SA (OBSV) Stock Skyrockets Following Global License Agreement with Organon

    ObsEva SA (OBSV) stock prices were up by 2.02% as of the market closing on July 26th, 2021, bringing the price per share up to USD$2.52 at the end of the trading day. Subsequent premarket fluctuations saw the stock surge by 32.94%, bringing it up to USD$3.35.

    OBSV Stock Partners with Organon

    July 27th 2021 saw OBSV stock announce having entered into an agreement with Organon, wherein Organon will license the global development, manufacturing, and commercial rights to ebopriprant (OBE022). The treatment is an investigational, orally active, selective prostaglandin F2α receptor antagonist that is being evaluated as a potential treatment for preterm labor. It is designed to reduce inflammation and uterine contractions. Pending approval, the treatment has the potential to be a first-in-class innovation for a problem that is widespread and serious. Currently, there are no approved therapies for the acute treatment of preterm labor in the United States.

    Ebopriprant (OBE022)

    The asset is currently in the development-stage and is being studied to address a leading unmet need for women around the world. The agreement is set to consolidate the company’s path to sustained growth over the long term as it helps build Organon’s women’s health research and development portfolio. The partners share a vision to improve the women’s health landscape around the world, hoping to revolutionize the healthcare space.

    Facilitating Development

    Organon is an ideal strategic partner for OBSV stock in the collaborative drive to develop and commercialize ebopriprant. Collaboration is a critical step in advancing the investigational agent. While preterm births are on the rise, no other known compounds are currently in development. For this reason, the company is focused on evaluating the treatment of a significant area of unmet need.

    Details of Agreement

    As per the terms of the agreement, Organon is set to acquire exclusive global rights to develop and commercialize the treatment. OBSV stock will receive compensation via tiered double-digit royalties on commercial sales, as well as up to USD$500 million paid upfront and through milestone payments. Upon signing, OBSV is set to receive USD$25 million, up to USD$90 million in development and regulatory milestones, and up to USD$385 million sales based milestones.

    Future Outlook for OBSV

    Armed with its expansive new strategic partnership, OBSV stock is poised to capitalize on the additional opportunities within its reach. The company is keen to leverage the resources at its disposal to drive organic growth over the long term, thereby facilitating increases in shareholder value.