Ten new option listings and two option delistings on January 23rd » 08:3001/2301/23/20
AKRO, AQST, CYCN, ITRN, OBSV, PHAS, PHAT, STOK, XP, MDR, TOO
New option listings for…
New option listings for January 23rd include Akero Therapeutics Inc (AKRO), Aquestive Therapeutics Inc (AQST), Cyclerion Therapeutics Inc (CYCN), Ituran (ITRN), McDermott International Inc (MDRIQ), ObsEva (OBSV), PhaseBio Pharmaceuticals Inc (PHAS), Phathom Pharmaceuticals Inc (PHAT), Stoke Therapeutics Inc (STOK), and XP Inc (Class A Stock) (XP). Option delistings effective January 23rd include McDermott International Inc (MDR) and Teekay Offshore Partners LP (Units) (TOO).
|Over a week ago|
JPMorgan to hold a conference » 09:5801/1501/15/20
ABBV, AKRO, GKOS, MORF, RCM, TWST, XRAY, QDEL, CYCN, HQY, PCRX, AKBA, ALKS, ITCI, AVNS, BCRX, NVST, ANAB, TECH, TMDX, OBSV, IART, CRNX
38th Annual Healthcare…
38th Annual Healthcare Conference will be held in San Francisco on January 13-16 with webcasted company presentations to begin on January 15 at 10:30 am; not all company presentations may be webcasted. Webcast Link
ObsEva, Yuyuan announce sublicense agreement to develop, commercialize nolasiban » 05:1001/1301/13/20
ObsEva and Yuyuan…
ObsEva and Yuyuan BioScience Technology announced that they have entered into a sublicense agreement to develop and commercialize nolasiban for improving clinical pregnancy and live birth rates in women undergoing embryo transfer following in-vitro fertilization, or IVF, in the People's Republic of China, or PRC. Nolasiban is a novel, oral oxytocin receptor antagonist, for which two Phase 3 studies have been completed in Europe. Under the terms of the agreement, Yuyuan has the exclusive rights to develop and commercialize nolasiban in the PRC. They will fund all development and registration activities in the PRC starting with the commitment to fund and conduct a Phase 1 study and a Phase 2 Proof-of-Concept study in China. Both companies plan to collaborate on the subsequent global development of nolasiban, but Obseva will retain worldwide rights to the product outside of the PRC. In addition, both companies will seek to expand their collaboration in China on other projects. Financial terms of the deal are not being disclosed.
|Over a month ago|
ObsEva price target raised to $40 from $36 at H.C. Wainwright » 08:1112/1912/19/19
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for ObsEva to $40 from $36 saying the company reported positive top-line data from one of two pivotal Phase 3 trials of linzagolix, its lead gonadotropin-releasing hormone receptor antagonist candidate for treatment of endometriosis and uterine fibroids. The analyst continues to expect linzagolix to demonstrate a "best-in-class" product profile overall within the GnRH receptor antagonist class. He reiterates a Buy rating on the shares.
Kezar Life Sciences appoints Elizabeth Garner to board of directors » 07:1312/1912/19/19
Kezar Life Sciences (KZR)…
Kezar Life Sciences (KZR) announced the appointment of Elizabeth Garner, MD, MPH to its Board of Directors. Dr. Garner is currently the CMO of ObsEva (OBSV).
ObsEva to host conference call » 07:2512/0912/09/19
Conference call to…
Conference call to discuss PRIMROSE 2 trial results will be held on December 9 at 8 am. Webcast Link
ObsEva says PRIMROSE 2 Phase 3 trial met primary, secondary efficacy endpoints » 05:1012/0912/09/19
ObsEva reported positive…
ObsEva reported positive Phase 3 trial results from the PRIMROSE 2 trial of linzagolix for the treatment of heavy menstrual bleeding, or HMB, due to uterine fibroids. The PRIMROSE 2 trial enrolled 535 women with HMB due to uterine fibroids. The trial was conducted in Europe and the U.S. and evaluated the efficacy and safety of once daily oral linzagolix, including 100 mg and 200 mg doses, both with and without hormonal add-back therapy, or ABT. The primary efficacy endpoint was the reduction in HMB. Responders were defined as patients with menstrual blood loss volume of less than or equal to 80 mL and greater than or equal to 50% reduction from baseline in menstrual blood loss volume at 24 weeks, measured using the alkaline hematin method. Bone mineral density, or BMD, was assessed centrally using Dual Energy X-ray Absorptiometry, or DEXA, scan at baseline and 24 weeks. The responder rate was 93.9% for women receiving 200 mg with ABT and 56.7% for women receiving 100 mg without ABT, compared to 29.4% in the placebo group. Both doses achieved significant rates of amenorrhea, reduction in pain, and improvement in quality of life. Additionally, significant improvement in hemoglobin levels, a reduction in number of days of bleeding and reduction in uterine volume were observed. Furthermore, a significant reduction in fibroid volume was also observed for the 200 mg dose with ABT. The overall safety profile was in line with expectations and confirmed that linzagolix was well-tolerated. The most frequently observed adverse events, occurring in greater than 5% of patients, were headache, hot flushes, and anemia. Mean percentage change from baseline in BMD was consistent with previous clinical data.
ObsEva price target lowered to $36 from $44 at H.C. Wainwright » 07:0712/0212/02/19
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for ObsEva to $36 from $44 after the company last month reported that the Implant 4 trial of nolasiban had failed to meet its primary endpoint. The analyst, however, feels that ObsEva shares remain undervalued solely based on the prospects of linzagolix. He reiterates a Buy rating on the name.
ObsEva downgraded to Neutral from Outperform at Credit Suisse » 06:4011/0811/08/19
Credit Suisse analyst…
Credit Suisse analyst Martin Auster downgraded ObsEva to Neutral from Outperform with a price target of $4, down from $16. The failure of nolasiban removes a major potential upside driver from the stock and reduces the company's financing flexibility, Auster tells investors in a research note. ObsEva will now need to secure additional financing to fund operations through linzagolix endometriosis Phase 3 results and subsequent commercial launch, the analyst adds. When combined with an "increasingly challenging" commercial proposition for linzagolix, he sees a "difficult development path ahead" for the company.
ObsEva says IMPLANT 4 study did not meet primary endpoint » 05:4311/0711/07/19
ObsEva SA announced that…
ObsEva SA announced that the Phase 3 clinical trial results from its European confirmatory study of nolasiban, or IMPLANT 4, in women undergoing embryo transfer, or ET, following in-vitro fertilization, or IVF, did not meet the primary endpoint of an increase in ongoing pregnancy rate at 10 weeks. Nolasiban was well tolerated. All subjects will continue to be followed up to delivery and infant development will be assessed up to 6 months.