|Bid||4.8200 x 1000|
|Ask||4.8400 x 1300|
|Day's Range||4.5899 - 5.2300|
|52 Week Range||1.6300 - 12.5000|
|Beta (5Y Monthly)||0.66|
|PE Ratio (TTM)||N/A|
|Earnings Date||May 05, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||15.50|
Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peak (Biotech Stocks Hitting 52-week Highs June 3) * Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * Fortress Biotech (NASDAQ: FBIO) * Imara Inc (NASDAQ: IMRA) * Inari Medical Inc (NASDAQ: NARI) * Intellia Therapeutics Inc (NASDAQ: NTLA) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Keros Therapeutics Inc (NASDAQ: KROS) * ORIC Pharmaceuticals Inc (NASDAQ: ORIC) * Phathom Pharmaceuticals Inc (NASDAQ: PHAT) * Pliant Therapeutics Inc (NASDAQ: PLRX) (went public Wednesday) * Protara Therapeutics Inc (NASDAQ: TARA) * Qiagen NV (NYSE: QGEN) * Turning Point Therapeutics Inc (NASDAQ: TPTX) * United Therapeutics Corporation (NASDAQ: UTHR)Down In The Dumps (Biotech Stocks Hitting 52-week Lows June 3) * Cellectar Biosciences Inc (NASDAQ: CLRB) (priced a $20-million common stock offering) * Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) * Genfit SA (NASDAQ: GNFT)Stocks In Focus Kezar Reports Positive Early Stage Results For KZR-616 In Systemic Lupus Erythematosus Kezar Life Sciences, Inc. (NASDAQ: KZR) announced updated results from the Phase 1b portion of the Phase 1b/2 MISSION study, which is evaluating the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus with and without nephritis, showing overall improvements across seven measures of disease activity.Two of two patients with lupus nephritis experienced a greater than 50% reduction in proteinuria, a biomarker of disease severity, according to the company. A positive safety and tolerability profile was observed with step-up dosing of KZR-616, Kezar said. The stock jumped 48.32% to $6.63 in premarket trading Thursday.AcelRx Ends Bid For Tetraphase Following a bidding war for Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) that saw the contenders sweetening their offers a few times, AcelRx Pharmaceuticals Inc (NASDAQ: ACRX), one of the contenders, said it does not intend to revise further its offer and that the offer is likely to be terminated by Tetraphase.This leaves the path clear for a takeover of Tetraphase by Melinta.AcelRx is eligible to receive a break-up fee of $1.8 million.AcelRx shares were up 1.55% at $1.31 at the time of publication during Thursday's premarket session, while Tetraphase shares were down 1.34% at $2.21. See also: The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight ObSeva Announces Positive Pilot Study Results From Linzagolix In Adenomyosis Obseva SA (NASDAQ: OBSV) announced the publication in the journal Fertility and Sterility of a case report from a pilot study assessing the use of linzagolix for the treatment of uterine adenomyosis. The study showed the patient treated with linzagolix saw alleviation of symptoms such as cessation of bleeding, improvement in pelvic pain, resolution of anemia and shrinkage of uterus at week 12.The symptoms continued to improve with the subsequent 12 weeks of treatment, and the effect lingered at eight weeks following the treatment.Pending confirmation of the results in additional patients, ObsEva said it may pursue additional studies to support supplemental labeling for the treatment of adenomyosis in reproductive-age women.The stock was down 5.66% at $5 premarket. Roche Obtains FDA Emergency Use Authorization For Test To Identify High-Risk Coronavirus Patients Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said the FDA has issued an Emergency Use Authorization for the Elecsys IL-6 test, which measures levels of the biomarker interleukin 6 and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. AstraZeneca Announces Oncology Partnership With Accent For Up To $1.2B AstraZeneca plc (NYSE: AZN) announced a collaboration with Accent Therapeutics to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins for the treatment of cancer.The agreement provides for AstraZeneca paying Accent a $55 million upfront and up to about $1.1 billion in total milestones, plus tiered royalties.In premarket trading, Thursday, AstraZeneca shares were gaining 0.36% to $55.20. Tiziana Gets NIH Grant For Studying Nasal Anti-CD3 Therapy For Alzheimer's Disease TIZIANA LF SCIE/S ADR (NASDAQ: TLSA) said the chairman of its Scientific Advisory Board, Dr. Howard Weiner, has received a competitive research grant from the NIH to investigate nasal anti-CD3 for the treatment of Alzheimer's disease.The company said it has licensed the anti-CD3 mAbs from Brigham and Women's Hospital, Harvard Medical School, Boston, and that it has completed two Phase 1 trials. It also said it expects to initiate two Phase 2 trials shortly for nasally and orally administered Foralumab for the treatment of progressive multiple sclerosis and Crohn's disease, respectively. The stock was adding 4.89% to $6.87 in premarket trading Thursday.EULAR Presentations Gilead Sciences, Inc. (NASDAQ: GILD) and GALAPAGOS NV/S ADR (NASDAQ: GLPG) announced at the at the European League Against Rheumatism, EULAR, E-Congress, Week 52 results from the Phase 3 FINCH 1 and FINCH 3 studies of filgotinib in adults with moderately to severely active rheumatoid arthritis, which demonstrated sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations.Novartis AG (NYSE: NVS) announced full 52-week results from the Phase 3 PREVENT trial, which reinforced the substantial and sustained benefits of Cosentyx across the axial spondyloarthritis spectrum."The study found patients treated with Cosentyx 150 mg showed significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks," the company said.Novartis shares were rising 0.62% to $86.23 in premarket trading Thursday.Offerings Twist Bioscience Corp (NASDAQ: TWST) said it has priced its underwritten public offering of 3.03 million shares of its common stock at $33 per share for gross proceeds of $100 million. The company expects the offering to close on or about June 8.The stock was down 5.07% at $35.19 premarket. Aileron Therapeutics Inc (NASDAQ: ALRN) said it has commenced an underwritten public offering of shares of its common stock. All the shares earmarked for the offering are sold by the company.The stock was down 13.74% at $1.13 premarket. On The Radar PDUFA Dates The FDA is set to rule on Merck & Co., Inc. (NYSE: MRK) sNDA for its triple combo antibiotic Recarbrio.Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates See more from Benzinga * Revisiting The Coronavirus Vaccine Race: Updates On The 10 Candidates In Clinics * The Daily Biotech Pulse: Regulatory Delay For Novartis' Multiple Sclerosis Drug, FSD Gets Nod For COVID-19 Study * The Daily Biotech Pulse: FDA Nod For Roche's Combo Therapy In Liver Cancer, Allena Rips Higher, Pfizer To Invest Up To 0M In Biotechs(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
ObsEva SA (OBSV) (SIX:OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported publication in the journal Fertility and Sterility of “Gonadotropin-releasing Hormone Antagonist (linzagolix): a New Therapy for Uterine Adenomyosis,” a case report from a pilot study assessing the use of linzagolix for the treatment of uterine adenomyosis. Adenomyosis is an estrogen-driven condition in which endometrial tissue (inner uterine lining) is present within the myometrium (muscular uterine wall), resulting in uterine enlargement, heavy menstrual bleeding, dysmenorrhea (painful menses) and infertility. Adenomyosis affects between 20 and 35% of reproductive-aged women, and may co-exist with endometriosis and/or uterine fibroids.
Geneva, Switzerland and Boston, MA – May 29, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to.
ObsEva SA (NASDAQ:OBSV) shareholders will have a reason to smile today, with the analysts making substantial upgrades...
Geneva, Switzerland and Boston, MA – May 8, 2020 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and.
Shareholders will be ecstatic, with their stake up 30% over the past week following ObsEva SA's (NASDAQ:OBSV) latest...
Take your eye off the ball, and you might have just missed a home run. Veteran players of the stock picking game know that biotechs are capable of delivering a win at what feels like the drop of a hat. How do they do it?It comes down to the nature of the industry itself. Unlike names in other sectors, biotech companies rely on only a few key indicators like study results or regulatory approvals to determine whether or not sustainable revenues are on the horizon. As a result, a favorable outcome can act as a catalyst that sends shares flying out of the ballpark. For this reason, risk-tolerant investors flock to these stocks. However, biotech stocks are famous for being risky as the opposite also holds true.This makes it difficult to separate the biotechs with massive growth prospects from those poised to strike out. Don’t worry, Wall Street analysts can lend a hand with that.Turning to Wedbush analyst Liana Moussatos for guidance, we wanted to check out some of her recent picks in the biotech space to see if she could steer us towards any game-changers. After running the tickers through TipRanks’ database, we found out that three recently scored Buy ratings from the rest of the Street and sport triple-digit upside potential. Liquidia Technologies, Inc. (LQDA)By leveraging its innovative PRINT technology, Liquidia wants to enhance the clinical profile of approved active pharmaceutical ingredients (APIs). Following its recent data readout, several analysts think this biotech is a long-term winner.On April 30, the company published the final data set from the pivotal Phase 3 INSPIRE trial for its lead candidate, LIQ861, as a presentation on the International Society for Heart & Lung Transplantation virtual education platform (ISHLTv). The therapy is a dry powder formulation of inhaled treprostinil (reference drug TYVASO), and was designed for the treatment of Pulmonary Arterial Hypertension (PAH).Based on the trial’s final analysis, the data was consistent with earlier results, with the asset exhibiting a robust safety profile in 121 patients. It should be noted that 113, or 93% of these patients, completed two months of treatment.Calling LIQ861 “potentially best-in-class", Moussatos points out that it was evaluated across doses ranging from 26.5 mcg to 159 mcg, and no drug-related serious adverse events (SAEs) were witnessed. The implications? LQDA is progressing right on track, with the therapy’s PDUFA date in PAH slated for November 24, 2020.Moussatos commented, “The NDA package included positive results from three clinical studies that highlight safety, tolerability and pharmacokinetics (PK) of LIQ861. Based on positive safety and efficacy data, we anticipate approval for LIQ861/PAH as highly likely and project potential U.S. approval on or before the November 24, 2020 PDUFA date, commercial U.S. launch in May 2021, and gross annual U.S. sales reaching over $660 million in 2027.” Along with her Outperform call, Moussatos left a $41 price target on this biotech stock. This implies shares could skyrocket 606% in the next twelve months. Like Moussatos, other analysts take a bullish approach when it comes to LQDA. With 100% Street support, the message is clear: the stock is a Strong Buy. At $37, the average price target puts the upside potential at 537%. (See Liquidia stock analysis on TipRanks)ObsEva SA (OBSV)Moving on to an entirely different segment of the biotech space, ObsEva develops treatments for women’s reproductive health, including Linzagolix for endometriosis and uterine fibroids (UF), and OBE022 for the prevention of premature labor. While shares have climbed 27% higher in the last month, Wedbush believes its growth story is nowhere near its conclusion.With management stating that COVID-19 won’t delay the Phase 3 trials for Linzagolix in UF, PRIMROSE 1 and PRIMROSE 2, Moussatos tells investors that OBSV is “on-track to report Linzagolix/UF primary endpoint results following 24 weeks of treatment from the PRIMROSE 1 trial and the 52 weeks of treatment results from the PRIMROSE 2 trial.”In both of these trials, the company wants to demonstrate that both a 100mg once daily dose of Linzagolix without hormonal add-back therapy (ABT) and a 200mg once daily dose with ABT are effective and safe. It should also be noted that the primary endpoint of the PRIMROSE trials is response rate, which will be determined by the reduction in heavy menstrual bleeding (HMB) due to UF.Speaking to the probability of success, Moussatos points out that in December 2019, the company published strong top-line data from the PRIMROSE 2 study, with the therapy meeting the 24-week primary endpoint, menstrual blood loss of less than 80 mL and equal to or greater than a 50% decrease from the baseline. It also exhibited a 93.9% responder rate for 200 mg with ABT and a 56.7% responder rate for 100 mg without ABT. Not to mention it met multiple important secondary endpoints including a drop in pain.As a result, Moussatos thinks that the primary endpoint readout for the PRIMROSE 1 study will most likely be positive. She added, “ObsEva plans to submit an MAA and NDA for UF by year end 2020 and first half of 2021, respectively. Of note, ObsEva is engaged in discussion with commercial partners for Linzagolix and we anticipate a potential announcement in 2020. We project gross annual sales of more than $800 million in 2026 for UF.”Based on all of the above, Moussatos left an Outperform rating on OBSV shares along with a $30 price target, which leaves room for a whopping 949% potential twelve-month gain.Turning now to the rest of the Street, other analysts are in agreement. Only Buy ratings, 3 to be exact, have been received in the last three months, so the biotech stock gets a Strong Buy consensus rating. Should the $23.67 average price target be met, shares could soar 728% in the next year. (See ObsEva stock analysis on TipRanks)Catabasis Pharmaceuticals (CATB)Last up to bat, we have Catabasis Pharmaceuticals, which focuses on developing treatments for rare diseases. Even though it has already posted an impressive 49% one-month gain, if you ask Wedbush, there’s still plenty of fuel left in the tank.For Moussatos, the key value driver is CATB’s lead asset, edasalonexent, a first-in-class oral NF-kB inhibitor for the treatment of Duchenne Muscular Dystrophy (DMD). Management revealed on April 17 that it would be conducting a series of presentations on Phase 3 PolarisDMD baseline characteristics and edasalonexent compliance at the 2020 Muscular Dystrophy Association Virtual Poster Session. After this, the analyst believes top-line results from the global Phase 3 PolarisDMD trial, which are slated for release in Q4 2020, will serve as a major catalyst for shares. Not to mention positive data could open the door for a potential NDA submission in the first half of 2021.Looking at the trial specifically, the patients enrolled in Phase 3 PolarisDMD exhibited similar baseline characteristics to the participants in the Phase 2 MoveDMD study. This is important because during Phase 2, treatment with edasalonexent was well tolerated and demonstrated optimal growth patterns.On top of this, edasalonexent soft-gel capsules did not reduce compliance, which landed at 98%. Also noteworthy, in both Phase 2 MoveDMD and Phase 3 PolarisDMD, patients could swallow soft-gel capsules.All of this prompted Moussatos to comment, “Based on robust Phase 2 safety and efficacy data, we anticipate positive results from PolarisDMD trial in Q4 2020. The Company also initiated an open-label extension trial (GalaxyDMD) designed to provide long-term safety results to support the NDA filing.”As Moussatos estimates CATB’s cash runway will last until Q3 2021 and that gross edasalonexent sales will exceed $500 million in 2025, it’s no wonder she is optimistic. To this end, the analyst reiterated an Outperform rating and $15 price target, suggesting 152% upside potential.Judging by the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Only one other review was published recently, but it was also bullish. Therefore, CATB earns a Moderate Buy consensus rating. The $37.50 average price target is more aggressive than Moussatos’ and implies 530% upside potential. (See Catabasis stock analysis on TipRanks) To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
No impact from COVID-19 expected on timing of PRIMROSE 1 and 2 and PROLONG trial readouts, enrollment of new patients in EDELWEISS 2 and 3 on temporary holdLinzagolix Phase.
ObsEva SA (OBSV) (SIX:OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported that there will be an online publication of two abstracts in Obstetrics and Gynecology (The Green Journal), the official journal of the American College of Obstetricians and Gynecologists, on Thursday 23rd April at 5pm ET. The abstracts, titled “Quality of Life Results After 52 Weeks of Treatment with Linzagolix for Endometriosis-Associated Pain” and “Linzagolix for Endometriosis-Associated Pain: Lipid Changes After 52 Weeks of Treatment” are based on 52-week data from the EDELWEISS trial, a Phase 2b randomized, double-blind, placebo-controlled, dose-ranging trial conducted in the US and Europe to assess the safety and tolerability of a range of daily oral linzagolix doses (50 to 200 mg) in women with moderate to severe endometriosis-associated pain.
Even the best investor on earth makes unsuccessful investments. But it should be a priority to avoid stomach churning...
Tuesday 14, 2020 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, announced today that its board of directors approved on April 10, 2020 an increase of its share capital from 48,567,605 to 51,876,001 through the issue of 3,308,396 new registered shares at an issue price of 1/13 of a Swiss Franc each, after registration of 11,941 new shares issued out of the company’s conditional share capital. The 3,308,396 new shares, to be issued out of the company’s authorized capital, will be fully subscribed for by ObsEva USA Inc., its 100% wholly owned subsidiary, and listed on the SIX Swiss Exchange on or around April 29, 2020.
April 6, 2020 – ObsEva SA (OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health today announced the nomination of Fabien de Ladonchamps, Vice President Corporate Affairs & Finance, as interim Chief Financial Officer and member of the Executive Committee, following the resignation of Tim Adams, effective close of business April 10, 2020. Tim Adams has served as CFO of ObsEva since January 2017 and is departing the Company to pursue a new opportunity.
Geneva, Switzerland and Boston, MA – March 27, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to.
ObsEva SA (OBSV) (SIX:OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today provided an update regarding the impact of the COVID-19 pandemic on its clinical development programs. "Our top priority is the safety of all the women who are participating in our clinical trials, as well as the health and safety of our employees and the healthcare professionals and external partners conducting our trials,” said Ernest Loumaye, MD, PhD, CEO and Co-Founder of ObsEva.
Geneva, Switzerland and Boston, MA – March 5, 2020 - ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to.
Primary endpoint achieved in 94% of women in linzagolix Phase 3 PRIMROSE 2 trial in uterine fibroids Linzagolix Phase 3 PRIMROSE 1 six-month primary endpoint results and.
Geneva, Switzerland and Boston, MA – February 27, 2020 - ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to.
Geneva, Switzerland and Boston, MA – February 18, 2019 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to.
ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced it will provide corporate plans for 2020 and beyond during its participation at the JP Morgan Conference from January 13-16, 2020 in San Francisco. “2020 is an exciting year for ObsEva as we expect additional Phase 3 data from our linzagolix development program in uterine fibroids and the first regulatory filing for what we believe is a best-in-class compound” said Dr. Ernest Loumaye, ObsEva CEO and Co-Founder. Following recent of positive, 6 month Phase 3 trial results for uterine fibroids, we anticipate further data readouts in the second quarter of 2020; 6 month primary endpoint results are expected from the PRIMROSE 1 trial, and 12 month treatment results are expected from the PRIMROSE 2 trial.
ObsEva and Yuyuan BioScience Technology (“Yuyuan”) today 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 (IVF) in the People's Republic of China (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.
Catabasis (CATB) teams up with Duchenne UK to fund a phase II study of its pipeline candidate edasalonexent, now being developed to treat patients with non-ambulatory Duchenne muscular dystrophy.