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OBSV

ObsEva

$2.02 /

-0.07 (-3.35%)

05:31
03/23/20
03/23
05:31
03/23/20
05:31

ObsEva provides update related to COVID-19 pandemic

ObsEva provided an update regarding the impact of the COVID-19 pandemic on its clinical development programs. "Our top priority is the safety of all the women who are participating in our clinical trials, as well as the health and safety of our employees and the healthcare professionals and external partners conducting our trials," said Ernest Loumaye, MD, PhD, CEO and Co-Founder of ObsEva. "Today we are instituting new measures to support these priorities as we all work together to safely manage through the COVID-19 pandemic." ObsEva is working diligently with clinical sites, following regulatory, ethics committee, and health agency guidance related to the COVID-19 pandemic, to ensure the safety of employees and women participating in its clinical trials. Accordingly, the Company has assessed its ongoing clinical trials and evaluated potential approaches to enhance safety measures. Immediate action has been taken, including the implementation of a recommendation to conduct remote patient visits. At present, PRIMROSE 1 and PRIMROSE 2 trial results remain on track to be announced in the second quarter of this year, as previously planned. PRIMROSE 1 and PRIMROSE 2 are Phase 3 clinical trials of linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids. Both trials have completed the enrollment of approximately 500 women. In addition, the company continues to expect PROLONG trial results will be reported in the second half of 2020, as previously planned. PROLONG is the Phase 2a trial of OBE022 for the treatment of preterm labor at weeks 24-34 of gestation. EDELWEISS 2 and 3 are ObsEva's ongoing Phase 3 trials of linzagolix for the treatment of pain associated with endometriosis. In view of the expected logistical challenges with initial screening and uncertainty about continuity of treatment for randomized patients because of the COVID-19 pandemic, ObsEva has decided to place a voluntary hold on further screening and randomization of patients into these two trials until further notice. Clinical trial sites will be managing all randomized patients currently on treatment to proceed with enhanced safety measures and the trial protocol whenever feasible. ObsEva remains ready and committed to resume patient screening and randomization as the situation permits. Given the dynamic nature of the COVID-19 pandemic, ObsEva will continue to monitor its operations on a daily basis and will assess the need for further actions as appropriate. ObsEva has also assessed the impact of COVID-19 on its financial position. ObsEva is continuing to manage its expenses, including through a recent reduction in staff and employee benefits and delayed spending on EDELWEISS 2 and EDELWEISS 3. As of December 31, 2019, ObsEva had $69.4 million of cash and cash equivalents. With existing cash and cash equivalents together with amounts available to ObsEva to borrow under its credit facility and the aforementioned expense reductions, the Company expects to fund its operating expenses into the third quarter of 2021.

OBSV ObsEva
$2.02 /

-0.07 (-3.35%)

03/05/20 Wedbush
ObsEva price target raised to $40 after pipeline update at Wedbush
03/05/20 Wedbush
ObsEva price target raised to $40 from $36 at Wedbush
12/19/19 H.C. Wainwright
ObsEva price target raised to $40 from $36 at H.C. Wainwright
12/02/19 H.C. Wainwright
ObsEva price target lowered to $36 from $44 at H.C. Wainwright

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