Category: Stock Market

We can readily understand why investors are attracted to unprofitable companies. For example, although…

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Gilead Sciences, Inc (NASDAQ: GILD) announced Monday it was seeking complete Food and Drug Administration approval for its drug Remdesivir, which is being used in the treatment of COVID-19.What Happened The drugmaker said it has filed a New Drug Application with the FDA on the basis of two randomized, open-label, multi-center Phase 3 clinical studies conducted by itself, and one other study by Anthony Fauci-led National Institute of Allergy and Infectious Diseases.The company claims the drug led to faster recovery from COVID-19 compared to placebo, and a 5-to-10-day treatment led to clinical improvements. Gilead noted that the drug was well-tolerated with no "new safety signals identified.""Today's filing is an important milestone as we continue to partner with the U.S. government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19," Gilead Chief Medical Officer Merdad Parsey said.Why It Matters Remdesivir has received regulatory approvals in the European Union and Japan, according to Gilead. The drug is approved for emergency use in COVID-19 patients in the United States by the FDA.In July, the drugmaker provided additional data on the efficacy of Remdesivir, which associated the drug with an improvement in clinical recovery, and a 62% reduction in risk of mortality compared with standard of care.Pfizer Inc (NYSE: PFE) announced a multiyear agreement with Gilead this month to manufacture and supply Remdesivir, in order to combat the coronavirus crisis.Raymond James analyst Steven Seedhouse expressed a lack of confidence in Remdesivir, citing 2020 revenue guidance, which is upwards of $3 billion, and is predicated on the company selling 1 to 1.5 million courses at $2500 per course. The analyst said the company is uniquely tied to COVID-19.Price Action Gilead shares closed nearly 1.2% lower at $68.51 on Monday.See more from Benzinga * Inovio Coronavirus Vaccine To Enter Mid-To-Late Stage Testing In September * Facebook Forms New Group To Rationalize Payments Across Apps * Uber, Lyft Must Classify Drivers As Employees, In Compliance With California Law, Judge Rules(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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According to the Wall Street Journal, Amazon has had talks with Simon Property Group to discuss taking over space left by ailing department stores. The boom in e-commerce and the coronavirus pandemic have caused a large wave of large retailers to close their doors. The Final Round panel breaks down the details.

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Shares in Novavax (NVAX) rose 5% in Monday’s trading after the late-stage biotech announced positive second quarter earning results. However the stock subsequently pulled back 2.4% in after-hours trading.The vaccine maker also stated that it secured $2 billion in funding for development and commercialization of NVX-CoV2373, a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes Covid-19 disease.The funding consists of up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI); up to $60 million from the U.S. Department of Defense (DoD) funding; and up to $1.6 billion from the U.S. Government funding through its Operation Warp Speed project.“Novavax’ unprecedented development activities for NVX-CoV2373 and progress continued through the second quarter,” said Stanley C. Erck, CEO of Novavax. “Since identifying a candidate vaccine to address the COVID-19 pandemic in March, we’ve secured significant funding, implemented global manufacturing capacity and completed and reported our successful Phase 1 trial.”“We’ve also expanded our senior leadership team to advance our efforts to bring NVX-CoV2373 to market as rapidly as possible and grow our infrastructure to support commercial stage operation” he added.Indeed, NVAX aims to deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020 and has already secured the required global manufacturing capacity thanks to several manufacturing agreements. This includes the acquisition of Praha Vaccines for $167 million.Meanwhile, Novavax reported Q2 GAAP EPS of -$0.30 which beat Street estimates by $0.23. Revenue of $35.54 million topped Street expectations by $29.87 million- and represented an incredible year-over-year increase of 960%. Cash, cash equivalents, marketable securities and restricted cash of stood at $609.5 million, up from $82.2 million at the end of last year.Due to optimism over its coronavirus vaccine candidate, NVAX shares have exploded by 4,385% year-to-date. The vaccine candidate’s Phase 1 study results recently prompted H.C. Wainwright analyst Vernon Bernardino to raise his price target to a Street-high $290 (62% upside potential) from $132 and reiterate a Buy rating.“We look for the company to become a major player in vaccine development in the near future,” Bernardino told investors.“There is upside potential to our projections, as our models assume: (1) a price per dose of $20, which is in line with the low end of prices recently negotiated by some of Novavax’ competitors for vaccine supplies they’ve agreed to provide to the US government; (2) distribution of approximately 137M doses worldwide in 2021; and (3) the potential for the dose-sparing effects of Matrix-M adjuvant to double the number of doses of NVX-CoV2373 that could be available,” the analyst said. (See Novavax stock analysis on TipRanks).The rest of the Street has a cautiously optimistic outlook on the stock. The Moderate Buy analyst consensus shows 4 Buy ratings versus 1 Sell rating. The $227.60 average price target now indicates 28% upside potential from current levels.Related News: Pfizer Inks Deal To Manufacture Gilead’s Covid-19 Remdesivir Treatment AstraZeneca Strikes First China Manufacturing Deal For Covid-19 Candidate Gilead Submits New Drug Application With FDA For Remdesivir More recent articles from Smarter Analyst: * Inovio To Start Phase 2/3 Study Of Covid-19 Candidate In Sept.; Shares Drop 8% * UBS Lifts United Parcel’s PT On 'Favorable' Pricing Environment * Lyft Drops After Court Order To Classify Drivers As Employees * First Majestic Signs Over Potential 100% La Joya Stake To Silver Dollar

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Betting stocks like DraftKings and Penn Gaming fell on Monday following reports that the Big Ten voted to cancel the 2020 football season. Meanwhile, Rosenblatt raised its price target for DraftKings stock. Yahoo Finance’s Myles Udland, Dan Roberts, Akiko Fujita, and Ines Ferre discuss.

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Shares in Pluristem Therapeutics (PSTI) rose 6% in Monday’s pre-market trading after Germany’s health regulatory agency, the Paul Ehrlich Institute (PEI), approved Pluristem’s Phase II clinical protocol for its study of intramuscular injections of PLX PAD for the treatment of severe COVID-19.Forty patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled in the study.The primary efficacy endpoint is the number of ventilator free days during the 28 days from day 1 through day 28 of the study. Safety and survival follow-up will be conducted at day 60, week 26 and week 52.“We are pleased to expand our COVID-19 program to an additional territory and look forward to commencing a clinical trial of our PLX cells for the treatment of severe COVID-19 cases complicated by ARDS in Europe. Based on our discussions with the PEI, this will be a standalone study, with the active arm compared to the current standard of care” stated Pluristem CEO Yaky Yanay.In addition to this study in Germany, Pluristem is currently conducting a Phase II COVID-19 trial in the U.S. which will enroll 140 patients.The company believes its PLX cells will offer a key advantage in addressing the COVID-19 global pandemic. PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. The cells have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and as a result may potentially reduce the incidence and/or severity of COVID-19 pneumonia.Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection.Initial clinical data at the conclusion of a 28 day follow up from COVID-19 ICU patients that were treated under a Compassionate Use Program, were previously published. Following these results, Maxim Group’s Jason McCarthy reiterated his buy rating with a $12 price target.“A key driver of mortality in COVID-19 is the uncontrolled inflammatory response that occurs in the lungs upon viral infiltration, known as acute respiratory distress syndrome (ARDS). PLX cells have demonstrated early signals of efficacy (and continued safety) in COVID-19 ARDS patients” he commented. “It seems to us that regenerative medicine is moving closer to having its day” the analyst concluded. (See Pluristem stock analysis on TipRanks).Overall the stock scores a Strong Buy analyst consensus while the $14.50 average analyst price target indicates over 60% upside potential lies ahead- despite shares already rallying 128% year-to-date.Related News: AstraZeneca Strikes First China Manufacturing Deal For Covid-19 Candidate Amarin’s Vascepa To Take Part In Covid-19 Study In Adults With Heart Disease Moderna Secures $400M In Deposits For Supply Of Covid-19 Vaccine Candidate More recent articles from Smarter Analyst: * Stephens Puts Trade Desk On Hold After 2Q Revenue * FedEx Gains 5% As Bernstein Raises Stock To Buy * Northland Cuts Stamps.com To Hold Despite 2Q Earnings Beat * Foot Locker Pops 25% In Pre-Market On Surprise 2Q Sales, Profit Outlook

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Spot gold was down 1.1% at $2,004.61 per ounce by 0727 GMT after falling as much as 1.9% earlier, accelerating a retreat from a record high of $2,072.50 hit last week. U.S. gold futures fell 1.3% to $2,013.10 per ounce. China on Monday had imposed sanctions on 11 U.S. citizens, including lawmakers from President Donald Trump’s Republican Party, after Washington’s sanctions on Hong Kong and Chinese officials last week.

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