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Gilead Sciences, Inc. (GILD)

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  • A
    The start of article reads-– Real-World Evidence from Nearly 100,000 Hospitalized Patients Provides Clinical Insights on the Use of Veklury for the Treatment of COVID-19 –

    FOSTER CITY, Calif., Jun 21, 2021--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury® (remdesivir). Presented at the World Microbe Forum (WMF) this week, all three of the real-world analyses observed that, in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls. A reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different timeframes over the course of the pandemic and across geographies. Two of the studies also observed that patients who received Veklury had a significantly increased likelihood of discharge from the hospital by Day 28.
  • J
    Kite and Shoreline Bio have announced a strategic partnership to develop novel cell therapies across a variety of cancer targets. Under the terms of the agreement, Shoreline will receive an upfront payment and will be eligible to receive additional payments totalling over $2.3B as well as royalties based on achievement of certain development and commercial milestones.

    The collaboration will leverage Shoreline's expertise in iPSC differentiation and genetic reprogramming in combination with Kite’s extensive cell therapy development, commercialisation and manufacturing expertise. It will focus initially on CAR-NK targets, with Kite having an option to expand the collaboration to include an iPSC CAR macrophage program for an undisclosed target to be selected post deal execution.
  • F
    Frank B
    Look at today's news on Gilead and you will get a better understanding of O'day 's philosophy when it comes to acquisitions. Small investment with promising company pipeline for big reward and less risk.
  • A
    SA article by E Ingham
    • Management is forecasting for a stunning operating profit of $11.5-$12.9bn in FY21, or EPS of $6.75-$7.45. Share buybacks and a generous dividend also benefit investors.
    • Under new CEO Daniel O'Day, ex-CEO of Roche's Pharmaceutical Division, Gilead is building an oncology franchise to replace an HCV division that has all but disappeared.
    • Gilead has had some setbacks, and its M&A activity has been questionable, but it potentially has years to put that right, without damaging its very strong profitability.
  • b
    Well, can someone with actual knowledge please explain to me what we are witnessing over the past 2 trading sessions? We ended the day on Thursday well above 69. We were up in AH on Thursday. We were up in PM on Friday. Then, before the opening bell on Friday, Foster City tells us we just received a significant FDA approval. All signs pointed to crushing the 70 level. And what happened? We were Red the entire day on Friday. I mean the entire day. No early bounce and then a retreat. Red all day! No negative news. Nothing whatsoever to indicate a complete 180 in PPS direction. And now, here we are on Monday morning and the tanking continues. Did I miss some huge negative event on Friday? All I saw was an FDA approval and suddenly we are back to the same old pattern of giving back our modest gains. We are truly in the Twilight Zone….unbelievable!!
  • B
    If MTNB's and NIH's oral LNC formulations of GILD's Remdesivir show promise, global sales of Remdesivir should expand significantly with improved patient safety benefits and lower costs.
  • I
    Interesting assessment and they maintain their $81 "fair value" rating.

    Fair Value and Profit Drivers Karen Andersen, CFA, Sector Strategist, 18 Jun 2021
    We're maintaining our fair value estimate at $81 per share.

    We assume Gilead's HCV business will stay relatively flat near $2 billion in 2021, with annual declines
    back in the double digits for the next few years. We think Gilead's HIV/HBV franchise has plateaued
    around $18 billion, with TAF-based combination regimens (Biktarvy, Genvoya, Descovy, and Odefsey)
    offsetting declines from older drugs. The recent Myr deal in hepatitis delta brings Hepcludex, which we
    expect to see sales as high as $1 billion annually. In COVID-19, we think Veklury could see another $2.4
    billion in sales in 2021.

    In oncology, we include $1.8 billion in sales from Yescarta and Tecartus by 2025, with annual sales
    stabilizing around this level as usage expands to second-line DLBCL therapy and other forms of blood
    cancer, but the competitive landscape gets tougher. Overall, we think magrolimab could see probabilityweighted sales approaching $1 billion, with initial sales starting in early 2023. The Immunomedics deal should give Gilead solid footing in oncology and a significant boost to top-line growth, but it came at a
    high price; we assume Trodelvy sales could surpass $7 billion if approved in multiple indications by

    In immunology, following continued disappointments for the Jyseleca/filgotinib program, our sales
    forecast reflects ex-U.S. royalties from Galapagos rather than a 50/50 profit share, and we assume a
    50% probability of filgotinib's approval in GI indications.

    We assume a 6.9% cost of capital for Gilead. We rate the systematic risk surrounding Gilead shares as
    below average and assume a cost of equity of 7.5% to align our capital cost assumptions with the
    returns equity investors are likely to demand over the long run. We also assume a 5.5% pretax cost of
    debt to reflect a more normalized long-term rate environment
  • F
    Frank B
    Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis
    Tell me again about buying Kite
  • A
    Remdesivir with a combination therapy could increase effectiveness 10 times. It can be developed taking advantage of the synergistic effects of the HCV drugs and the potent neutralizing capabilities of the remdesivir metabolite. We already know HCV antivirals boost the potency of remdesivir, so it is possible that a similar effect could take place with the metabolite. As an added advantage, the protease, the ADP-ribose inhibitor, and remdesivir are available to be administered orally, meaning a combination could likely come in this form as well. These are just two of many antivirals that could be combined in a unilateral attack on NSP3. The protein has so many crucial targets; we must take advantage.

    The researchers further demonstrated that these four drugs also acted synergistically with remdesivir to inhibit SARS-2 replication, thereby increasing remdesivir antiviral activity as much as 10-fold. In contrast, the HCV drugs BOC and NAR, which inhibit the NSP5 protease but not the NSP3 protease acted additively rather than synergistically with remdesivir. This suggested that the combination of an HCV protease inhibitor with an RNA polymerase inhibitor could potentially function as an antiviral against SARS-CoV-2.
  • T
    Earnings on 7/1. Remdesivir singlehandedly CARRIED this company last quarter. With US new cases and deaths at its historic lows, and the declining cases worldwide, pop quiz: do you think Remdesivir sales will bail out GILD this quarter as well? My secret plan is to sell most of my shares if there is any pop before upcoming earnings (that's a HUGE if) and buy it back much, much cheaper after earnings. Don't copy me.
  • F
    Frank B
    They need the inhaled version that will go directly to the lungs and you can take when you have early symptoms of Covid and keep you out of the hospital. The pill form doesn't work because it has to go thru the stomach and it breaks down.
  • J
    States News Services
    Wednesday, June 16, 2021 873 mots

    ROCKVILLE, MD - The following information was released by the Regulatory Affairs Professionals Society:

    By Renee Matthews

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

    New approvals

    StrataGraft greenlighted for treating thermal burns in adults

    Mallinckrodt's StrataGraft has been approved as a topical application treatment for adults with thermal burns containing intact deep skin layers for which surgical intervention is clinically indicated.

    Deep thermal burns often require the removal of damaged skin and replacement with a skin graft, usually through an autograft using healthy skin from the patient. StrataGraft is placed on the burn wound to avoid or decrease the amount of healthy skin need for the graft.

    Approval of the therapy was based on findings from two randomized clinical studies in a total of 101 adults from the indicated population. In both studies, two deep partial-thickness burn wounds of comparable area and depth on each patient were identified and randomized to receive either a single topical application of StrataGraft or autograft alone. The effectiveness of StrataGraft was supported by the percentage of StrataGraft treatment sites that achieved a complete wound closure and the decreased need for autografts at the StrataGraft sites.

    StrataGraft was granted regenerative medicine advanced therapy, priority review, and orphan drug designations for this indication. It was developed in conjunction with the Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

    StrataGraft is produced from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bilayered cellularized scaffold. The human keratinocyte cells were grown with mouse cells during the early stages of product development, so StrataGraft is considered a xenotransplantation product (one that uses tissues or cells belonging to different species). Mouse cells are no longer used in the final manufacturing process. StrataGraft carries a risk of transmission of infectious diseases or agents because it contains cells from human donors and animal-derived materials from the early stages of product development, although no such transmission has been reported with StrataGraft.

    Rezipres approved for treating hypotension during anesthesia

    Eton's Rezipres (ephedrine hydrochloride injection) has been approved for treating patients who develop hypotension during anesthesia.

    Evidence for the efficacy of Rezipres was drawn from published literature, in which 14 studies reported increases in blood pressure after administration of ephedrine in the anesthesia setting. Nine of those studies included use of ephedrine hydrochloride in pregnant women undergoing neuraxial anesthesia during Cesarean delivery; one study was conducted in patients undergoing nonobstetric surgery under neuraxial anesthesia; and four studies included patients undergoing surgery under general anesthesia.

    New indications

    Trikafta nabs expanded indication for cystic fibrosis in younger children with certain mutations

    Vertex's Trikafta (elexacaftor, tezacaftor, ivacaftor combination and ivacaftor alone) has received an expanded indication for the treatment of cystic fibrosis in children aged 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.

    Approval of the combination therapy for this new indication was based on findings from a Phase 3, open-label, multicenter study in 66 children from the indicated population. The twice daily regimen, administered as morning combination and evening ivacaftor-alone doses, was generally well tolerated during the 24-week study and safety data were similar with those seen in earlier studies with children aged 12 or older.

    Trikafta was first approved in 2019 for treating cystic fibrosis in patients aged 12 or older with at least one F508del mutation.

    Epclusa gets new formulation for treating chronic HCV infection in children

    Gilead's Epclusa (sofosbuvir and velpatasvir) has received an expanded pediatric indication for treating chronic hepatitis C virus (HCV) in children as young as 3 years, regardless of HCV genotype or liver disease severity.

    The therapy is available in oral pellet formulation and in two strengths for younger children who cannot swallow tablets.

    Approval of Epclusa for this younger patient population was based on data from a Phase 2, open-label clinical trial with 41 children from the indicated population. At 12 weeks after treatment completion, the sustained virologic response (SVR 12), or cure rate, was 83% (34/41) among all patients, 88% (28/32) in those with HCV genotype 1, 50% (3/6) in those with HCV genotype 2, and
  • b
    JNCE is up over 10% on the news this morning. And Gild is Red! And once again, we are supposed to believe that all this retreating in the face of good news after good news is a residual result of the ex-dividend period? What a joke! If that’s true, then Foster City should have been smart enough to know this in advance and hold the info till later when the exit-dividend carnage was over…..am I wrong? This whole thing stinks to high heaven. Something is wrong here, something is terribly wrong….
  • A
    Hospitalizations are currently over 29,000 in the USA for both covid icu beds and inpatient beds. Half those are going to be taking FDA approved remdesivir. Merck does not have anything approved yet. Remdesivir more likely than not will not only beat merck to market with pill form but also become standard of care and win full fda approval.
  • A
    BRAZIL VARIANT PERSISTS IN CHILE DESPITE OVER 50% full VACCINATIONS. The development, which will alarm authorities elsewhere who are debating how fast to reopen as vaccination campaigns gather steam, comes as Chile's confirmed daily caseload surged 17% in the past two weeks nationwide and 25% in the Metropolitan region that includes Santiago and is home to half the country's population.
    Intensive care beds in the capital region are now at 98% capacity. Jose Luis Espinoza, the president of Chile's National Federation of Nursing Associations (FENASENF), said his members were "on the verge of collapse."
    Chile has one of the world's highest vaccination rates. Around 75% of its 15 million target population have already received at least one dose of vaccine, and nearly 58% are completely inoculated. On a per capita basis among larger countries, it the vaccination leader in the Americas and the fifth highest worldwide, according to Reuters data.
    It has used nearly 23 million vaccines doses so far - 17.2 million of Sinovac's, 4.6 million of Pfizer/BioNTech's, and less than 1 million each of AstraZeneca's (L:AZN) and CanSino's.
    Vaccines are not 100% effective, medical experts pointed out, and there is a time lag before they reach their highest efficacy. Also driving the fierce second wave is lockdown fatigue and the appearance of more contagious variants.

    Chile's health regulator, the ISP, said genome sequencing of infections between December and June had confirmed the Brazilian P1 variant was the most prevalent in the country, and "twice as contagious as the original strain.
  • G
    Instead of spending $33 BILLION for oncology drugs that make up 1% of sales, GILD could have issued a $30 per share dividend. I'd choose the latter.
  • F
    Frank B
    The silly non thinking post ; one , O’day wouldn’t sell because he makes all that money; like he wouldn’t get a package if he sells,duh.Two,the MM will not allow the price to exceed a certain price be cause options expire on Friday. Really, once upon a time options occurred every quarter then they occurred every month now they are weekly and with some daily , so based on that logic no stock should ever move and all options should expire worthless. Nothing should move a stock, earnings, breakthroughs, buyouts, lawsuits nada nada.
  • T
    The US DOT-COM BUBBLE 2021
    $^FTSE conversation
    INFLATION IS SKYROCKETING as the FED continues to PUMP the Price of everything, stocks, oil, gold, home, land, commodities, utilities, food prices and everything!
    The World Economy is Collapsing, people are starving, but the US Market Makers are too busy in printing money and PUMPING the Stock prices Artificially to make insiders trillionaire without working!
    Enjoy Free Capital Gains in the US Stock Market while the Corporate Revenues are tanking and the Economy is Collapsing! US Stock Market is a “GET QUICK RICH” Scheme!
    Dow Jones Industrial Average (^DJI) was 17,000 in 2016, with better economic fundamentals and higher corporate earnings. However, thanks to the Collapsing Economy, Coronavirus Pandemic, Tanking Corporate revenues and earnings, Skyrocketing unemployment, Trade Wars, Record INFLATION levels, and Heavy Stock Dilutions, Dow Jones Industrial Average (^DJI) BUBBLE has almost Doubled!
    S&P 500 (^GSPC) was at 1600.00 with better fundamentals and higher corporate earnings in 2016. Now it is sitting at ABSURD 3800.00 with TERRIBLE Fundamentals, Collapsing Economy, HEAVIER Corporate and National Debt and way lower corporate revenues and earnings!
    The World Countries are refusing to accept the US Dollar as international reserve currency due to the HEAVY Dollar PRINTING!
    US Stocks are INSANELY OVERVALUED and OVERBOUGHT! US Stock Market is a MEGA BUBBLE right now!!!


    There is growing angst among investors over financial market price bubbles, and top of the list of concerns were the cryptocurrency bitcoin and U.S. tech stocks, two closely followed surveys showed on Tuesday.
    There is growing angst among investors over financial market price bubbles, and top of the list of concerns were the cryptocurrency bitcoin and U.S. tech stocks, two closely followed surveys showed on Tuesday.
  • A
    News update: a good study recently released to show that prior infection with covid will SUBSTANTIALLY reduce, but not eliminate, the chance for reinfection for inly 10 months. Looks like remy lifespan is officially starting to increase. Again this does not include all of the recent mutant strains since they only came about recently.

    LONDON (Reuters) - Previous COVID-19 infection substantially reduces the risk of a new infection for up to 10 months afterwards, according to a study of care home residents and staff by University College London (UCL) scientists.
    The study, published in The Lancet Healthy Longevity http://www.thelancet.com/journals/lanhl/article/PIIS2666-7568(21)00093-3/fulltext on Thursday, found that care home residents who had been previously infected with COVID-19 were approximately 85% less likely to be infected between October and February than those who had not been infected.
  • G
    Gilead cures the world of every disease known to man, stock drops !!!! So frustrating.
    We will have our day, don't give up the ship.