OBSV - OBSV STOCK NEWS

ObsEva SA (NASDAQ: OBSV) reported significant progress in 2021, highlighted by FDA acceptance of the New Drug Application (NDA) for linzagolix, set for a PDUFA date of September 13, 2022. The company also received a positive opinion from the CHMP regarding linzagolix for uterine fibroids.

Financially, ObsEva's cash and equivalents rose to $54.7 million, due to net cash inflows primarily from an at-the-market offering program. Despite a net loss of $58.4 million, reduced R&D expenses were noted.

ObsEva SA (NASDAQ: OBSV) reported its 2021 financial results and provided key updates on its linzagolix franchise.

The company achieved significant milestones, including FDA acceptance of its New Drug Application for linzagolix for uterine fibroids, with a PDUFA target action date set for September 13, 2022. Additionally, a positive CHMP opinion was received in Europe. The linzagolix treatment also showed promising results in the Phase 3 EDELWEISS 3 trial for endometriosis. ObsEva's cash reserves rose to $54.7 million, aided by recent financing efforts, while the net loss decreased to $58.4 million, reflecting reduced R&D expenses.

ObsEva SA (NASDAQ: OBSV) announced a strategic licensing agreement with Theramex to commercialize linzagolix, an oral GnRH antagonist for uterine fibroids and endometriosis pain, in global markets outside the U.S., Canada, and Asia. ObsEva is set to receive mid-thirties percentage royalties on sales, with potential payments of up to EUR72.75 million, including EUR5 million at signing. Linzagolix has received FDA acceptance for review, with a PDUFA action date set for September 13, 2022. The partnership aims to address significant unmet medical needs in women's health.

ObsEva SA announced an update regarding its marketing authorization application for linzagolix as the European Medicines Agency (EMA) has indicated that further questions may arise, extending the application timeline. In the U.S., the New Drug Application for linzagolix has been accepted for review by the FDA, with a PDUFA target action date set for September 13, 2022. Linzagolix is a novel treatment for uterine fibroids and is also undergoing late-stage development for endometriosis pain, although it is not yet approved anywhere globally.

ObsEva SA announced the appointment of Katja Buhrer as Chief Strategy Officer, effective February 1, 2022. She will manage corporate strategy, investor relations, and public relations, vital as ObsEva transitions to a commercial-stage company. CEO Brian O’Callaghan highlighted Ms. Buhrer's experience in strategic transactions and partnerships as a key asset. Prior to this, she was with Kindred Biosciences, leading successful business initiatives. Ms. Buhrer aims to enhance shareholder value and address women's reproductive health challenges.

ObsEva SA has appointed Katja Buhrer as Chief Strategy Officer effective February 1, 2022. Buhrer will oversee corporate strategy, investor relations, and public relations, contributing to business development and alliance management. CEO Brian O’Callaghan expressed enthusiasm for Buhrer’s track record in corporate development and her previous experience at Kindred Biosciences. Buhrer is expected to enhance ObsEva’s value by exploring new partnerships and indications, aiming for multiple regulatory approvals in 2022, particularly in women's reproductive health.

ObsEva SA (NASDAQ: OBSV; SIX: OBSN) announced an increase in share capital from 85,220,471 to 108,620,471 shares on January 28, 2022, through the issuance of 23,400,000 new shares at an issue price of 1/13 of a Swiss Franc each. This capital increase is fully subscribed by its subsidiary, ObsEva USA Inc. Additionally, the company amended its convertible note financing agreement with JGB Management, Inc., expanding borrowing capacity to $135 million. This amendment includes adjusting terms for the second tranche notes issued, as well as issuing warrants for common shares.

ObsEva SA (NASDAQ: OBSV) reported positive results from the Phase 3 EDELWEISS 3 trial for linzagolix, an oral GnRH antagonist aimed at treating endometriosis-associated pain. The 200 mg dose combined with add-back therapy met co-primary efficacy objectives, showing significant reductions in dysmenorrhea and non-menstrual pelvic pain at 3 months. The 75 mg dose also showed improvement in dysmenorrhea but did not meet the non-menstrual pelvic pain objective. Both dosages were well-tolerated with minimal adverse effects.

ObsEva announced positive topline results from the Phase 3 EDELWEISS 3 trial of linzagolix, an oral GnRH antagonist for endometriosis. The 200 mg dose with add-back therapy (ABT) met co-primary efficacy objectives, reducing dysmenorrhea and non-menstrual pelvic pain at 3 months, with significant improvements in secondary endpoints at 6 months. The 75 mg dose showed significant improvement in dysmenorrhea but not in non-menstrual pelvic pain. Both doses were well-tolerated with minimal bone mineral density decrease. Further data from follow-up studies are expected in mid-2022.