|Over a week ago|
Fly Intel: Pre-market Movers » 09:0201/0601/06/22
VCRA, OBSV, WBA, RGP, CAG, BBBY, BLI, SYK
Check out this morning's…
ObsEva announces results from Phase 3 EDELWEISS 3 trial of linzagolix » 07:1401/0601/06/22
ObsEva SA announced…
ObsEva SA announced "positive" topline results from the Phase 3 EDELWEISS 3 trial of linzagolix, an oral GnRH antagonist, in women with moderate-to-severe endometriosis-associated pain, EAP. Two doses were tested, a 200 mg once-daily dose of linzagolix in combination with add-back therapy, ABT, and a 75 mg dose of linzagolix without ABT. The 200 mg dose met the co-primary efficacy objectives, demonstrating reductions in dysmenorrhea, DYS, and non-menstrual pelvic pain, NMPP, at 3 months. There were statistically significant and clinically meaningful improvements in the first five ranked secondary endpoints at 6 months: dysmenorrhea, non-menstrual pelvic pain, dyschezia, overall pelvic pain, and ability to do daily activities. The 75 mg dose without ABT demonstrated a statistically significant reduction versus placebo in DYS at 3 months. Although it showed improvement in NMPP at 3 months, it did not reach statistical significance versus placebo, and thus did not meet the co-primary efficacy objective. Improvements were also observed at 6 months in the first five ranked secondary endpoints, as for the 200 mg plus ABT dose. Both linzagolix doses were generally well-tolerated with minimal BMD decrease and few adverse events occurring in more than 5% of patients up to 6 months.
Aspira Women's Health announces fourth quarter operational metrics, updates » 08:2601/0501/05/22
AWH, OBSV, ABBV
Aspira Women's Health (AWH) announced preliminary fourth quarter operational results and provided a corporate update. Operational Metrics Update: OVA1 volume in the fourth quarter of 2021 grew approximately 23.4% year over year to 4,750 units compared to 3,849 units in the fourth quarter of 2020. The number of tests for the fourth quarter represented a quarterly record and a 11% increase sequentially compared to the third quarter test volume of 4,281. The number of ordering physicians increased to approximately 3,211 for the fourth quarter of 2021, representing a year over year increase of 22.8% and a sequential increase of 10.2% for the quarter. The number of new physician additions increased 31% from third quarter of 2021 vs fourth quarter of 2021. Pipeline Update: OvaWatch: The company plans to launch our laboratory developed test OvaWatch in two stages - single use and serial monitoring. For the single use test, the company submitted the analytical validation manuscript in late November. It plans to launch the single use test following acceptance of both manuscripts. Launch of the serial monitoring test is currently planned for the end of 2022/early 2023. EndoCheck: Aspira is developing an LDT with the specimens provided by collaborators, ObsEva (OBSV) and AbbVie (ABBV), while simultaneously seeking FDA Breakthrough Designation for EndoCheck with the first FDA "Principles for Good Machine Learning Practices." Aspira also plans to hold a key opinion leader event in the first quarter of 2022 with top thought leaders in the field to discuss the disease, the clinical gaps, the regulatory opportunity with LDT's, and our science.
|Over a month ago|
ObsEva added to the Nasdaq Biotechnology Index » 07:0412/2012/20/21
ObsEva announced it has…
ObsEva announced it has been selected for addition to the NASDAQ Biotechnology Index, effective as of market open on Monday, December 20, 2021.
ObsEva announces positive CHMP opinion for linzagolix » 07:1012/1712/17/21
ObsEva announced that the…
ObsEva announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, adopted a positive opinion recommending approval of linzagolix, an oral GnRH antagonist for the management of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. ObsEva's Marketing Authorisation Application submission was based on positive data from the Company's two Phase 3 PRIMROSE trials. "The positive CHMP opinion is an important milestone for millions of women in the EU living with UF to address the diverse medical needs of the women who suffer from this condition," said Brian O'Callaghan, CEO of ObsEva. "We will continue our productive, ongoing dialogue with EMA toward potential marketing authorization in the EU, and in parallel, continue to work with the FDA to advance linzagolix through the U.S. regulatory process." The positive opinion adopted by the CHMP is based on 52-week treatment results from the Phase 3 PRIMROSE 1 and PRIMROSE 2 clinical studies as well as supportive results from the 76-week post-treatment follow-up periods of both trials. A final marketing authorization decision from the EC is anticipated within two months.
ObsEva price target lowered to $15 from $17 at H.C. Wainwright » 06:1711/2911/29/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju lowered the firm's price target on ObsEva to $15 from $17 and keeps a Buy rating on the shares post the Q3 results.
ObsEva announces FDA acceptance of linzagolix NDA » 05:3211/2211/22/21
Obseva announced that the…
Obseva announced that the new drug application, or NDA, for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the FDA. The submission is based on data from the two Phase 3 PRIMROSE trials. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones. The FDA set a target action date of September 13, 2022 for this NDA under the Prescription Drug User Fee Act.
Bolt Biotherapeutics appoints Brian O'Callaghan, Frank Lee to board » 08:1411/1911/19/21
BOLT, OBSV, FMTX
Bolt Biotherapeutics (BOLT) announced the appointments of Brian O'Callaghan and Frank Lee to the Board of Directors. With these additions, longtime Director Peter Moldt, Ph.D. is stepping down from the Board of Directors and current Director Jim Healy, M.D., Ph.D. will be assuming the role of Lead Independent Director. O'Callaghan currently serves as Chief Executive Officer at ObsEva SA (OBSV), a clinical-stage pharmaceutical company developing novel therapies to improve women's health. Lee currently serves as President and Chief Executive Officer of Forma Therapeutics (FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers.
ObsEva files to sell 11.5M shares of common stock for holders 17:2511/1011/10/21
ObsEva announces departure of CFO David Renas » 16:3110/2910/29/21
ObsEva SA announced that…
ObsEva SA announced that current Chief Financial Officer David Renas will be stepping down from his position for personal reasons, effective January 5, 2022. ObsEva has retained an executive search firm to assist the company's board with identifying a new Chief Financial Officer.