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      Why Shares of ObsEva SA (OBSV) Surged Pre-Market? - Stocks Telegraph

      By Gule Rukhsar

      Published on

      November 22, 2021

      11:32 AM UTC

      Why Shares of ObsEva SA (OBSV) Surged Pre-Market? - Stocks Telegraph

      At last check, ObsEva SA (OBSV) shares went up by 16.81% at a value of $2.71 in pre-market. The stock was at $2.32 at the last session’s close, marking an increase of 5.45% or that of $0.12. Intraday trading, the OBSV stock moved between $2.2101 and $2.3500 at a volume of 0.44 million. The volume was 63% of the company’s 65-day average volume and even less than its year-to-date volume of 2.57 million. In addition, the stock fluctuated between $1.90 and $5.55, over the past 52 weeks. The stock lost a value of 5.69% in the past week, while it lost 12.45% in the past month. Moreover, the stock gained about 11.5% year to date. OBSV trades at a market capital of $197.71 million and 85.22 million shares outstanding in the current market.

      ObsEva’s U.S. FDA acceptance of a new drug application on November 22, seems to be the cause of the stock’s uptrend.

      ObsEva SA (OBSV) is a clinical-stage biopharmaceutical company. It engages in the research and development of therapeutic treatments for women’s reproductive health.

      OBSV’s FDA Acceptance

      On November 22, the company announced that its drug Linzagolix has been accepted by FDA for New Drug Application (NDA). Linzagolix received NDA for the management of heavy bleeding associated with uterine fibroids. The data for the review was collected from two phases 3 PRIMROSE trials, in which the efficacy and safety of the drug were tested. Two different doses of the drug were investigated for the treatment of heavy bleeding associated with uterine fibroids. Uterine fibroids are tumors of the muscular tissue of the uterus. While these tumors are benign but their symptoms such as anemia, pelvic pressure, urinary frequency, and pain hugely affect the quality of life. The data showed very promising results. If approved, OBSV’s Linzagolix will provide much-needed options as well as relief to women suffering from uterine fibroids.

      The target action date for the NDA is September 13, 2022, as set by the FDA under Prescription Drug User Fee Act (PDUFA).

      The Company’s Financials

      On November 4, ObsEva SA (OBSV) announced its financial results for the third quarter ended September 30, 2021. As per the third quarter of 2021, the net income was $0.8 million, compared to a net loss of $24.4 million for the Q3 of 2020. Consequently, the net income per share for Q3 2021, was $0.01, against a net loss per share of $0.49 for Q3 2020.

      Moreover, OBSV’s cash and cash equivalents totaled $62.9 million on September 30, 2021, while it was $31.2 million on December 31, 2020.

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