Obseva SA (NASDAQ:OBSV) Stock Ends Lower In A Volatile Session After The News
Obseva SA (NASDAQ:OBSV) fell 4%despite announcing that the US FDA had accepted its NDA for linzagolix for heavy menses bleeding management related to uterine fibroids in women nearing menopause.
Market Stats
On Monday, OBSV stock fell 3.88% at $2.23 with more than 6.97 million shares, compared to its average volume of 699k shares. The stock has moved within a range of $2.1500 – 2.4400 after opening trading at $2.42.
Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix
The company supported the submission using data from its two-third phase PRIMROSE studies. Most importantly, if approved, linzagolix will offer a differentiated profile, and it will be the only and first GnTH receptor antagonist offering flexibility in dosing for uterine fibroids since it offers a low dose alternative for women not willing to take hormones. The FDA’s target action date has been set for September 13, 2022, for the NDA.
CEO Brian O’Callaghan said that this is a massive milestone for the clinical development process of linzagolix as well as for the company and the millions of women dealing with uterine fibroids across the US. He added that linzagolix is a great innovation in the women’s health field, which is an area that is underinvested. So investors should keep an eye on OBSV.
Key Quote
“Today marks an important milestone not only in the linzagolix clinical development process, but for Obseva as a company, and most importantly, the millions of women living with uterine fibroids throughout the US. Linzagolix is a significant innovation in the field of women’s health – an area that is consistently underinvested in – and we are incredibly excited about the potential of bringing this important treatment to market” said Brian O’Callaghan, CEO of Obseva. “We are encouraged by our positive Phase 3 PRIMROSE results. If approved, we believe linzagolix will address a significant unmet need in offering a more individualized treatment option for a broader range of women.”
Traders Corner
OBSV stock is below the 20-Day and 50-Day Moving averages of $2.44 and $2.75 respectively. Moreover, the stock is trading below the 200-Day moving average of $2.98. The stock is down 15% in the past month.
