GIS.F - Gilead Sciences, Inc.

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  • Scientists Are Already Working on Cures for Coronavirus
    Bloomberg

    Scientists Are Already Working on Cures for Coronavirus

    (Bloomberg Opinion) -- We aren’t completely unprepared for the Wuhan coronavirus now spreading around the world. Just ask the people who work in Tyvek suits and respirators, such as epidemiologist Timothy Sheahan of the University of North Carolina.He has been studying coronaviruses since 2003, shortly after a similar virus triggered the SARS outbreak, which also started in China and spread to North America. In the end, it killed fewer than 800 people but raised legitimate fears about a global pandemic.Now there’s a drug called remdesivir which Sheahan and his colleagues at UNC, in collaboration with Gilead Sciences, have been testing in a level 3 containment facility for its ability to fight a whole range of coronaviruses — so named for their spiky shape, which resembles a crown.Sheahan said their drug targets an enzyme that different kinds of coronaviruses need to replicate themselves. They’ve tested the drug in mice infected with the SARS virus, as well as MERS — Middle East respiratory syndrome — another coronavirus that has killed 851 people since it broke out in 2012. They published the MERS results this month in Nature Communications.Clinical trials in these cases usually test drugs’ effectiveness as compared with other therapies, rather than against a placebo. Such comparative testing is still being done with Ebola — which is currently infecting people in the Democratic Republic of Congo. Though Ebola is not a coronavirus, it is, like SARS and the new infection, a so-called RNA virus, and so doctors tested remdesivir against other Ebola therapies. It didn’t perform as well as a different kind of therapy, but it did prove reasonably safe.Sheahan says his work is part of a program on emerging infectious diseases, funded by the National Institutes of Health. How did the NIH have the foresight to fund research on coronavirus cures, when there hasn’t been a case of SARS since 2004 and there’s little fear that MERS will spread in the United States?Experts say they knew it was likely that another dangerous coronavirus would emerge in China. That’s because SARS — which stands for Severe Acute Respiratory Syndrome — was eventually found to come from wild bats, and bats carry a whole cauldron of different strains of SARS-like coronaviruses. Bats are considered a “reservoir” for coronaviruses because they can carry them without getting sick.The story of SARS is well-told in David Quammen’s book “Spillover: Animal Infections and the Next Human Pandemic.” A determined group of investigators swabbing thousands of animals eventually found that people in China got the disease from eating small mammals called civets. The civets were likely infected by bats in a so-called wet market, where a vast array of wild and domestic species are stored in stacked up cages and exposed to one another’s wastes and germs before being butchered. The Chinese killed thousands of civets in an attempt to eradicate the virus, before they realized it was going to remain indefinitely in the bodies of wild bats — which some people there still consider a delicacy. The new disease appears to have emerged from a seafood market that also sold live mammals and birds, though the original animal host has yet to be identified.SARS was, ultimately, the story of a bullet dodged. According to Quammen’s account, the factor that worked in humanity’s favor was the pattern of contagion. While influenza tends to spread most readily when people first get sick, before the peak of their symptoms, SARS becomes most transmissible during or after symptoms hit their peak. It’s a lot easier to quarantine people who are or have been sick than those who have yet to notice symptoms.If the scientists working in level 3 containment facilities to develop cures can be thought of as the “special ops” part of the effort to protect the public, there’s also important work being done by the infantry: making sure hospitals worldwide are using the best standards for sanitation and protection of healthcare workers. All hospitals should be equipped to diagnose the disease, says virologist David Sanders of Purdue University, and regional centers should be set up as needed to treat patients.One chilling aspect of the SARS epidemic was the speed with which health care workers got sick and died. It happened in Asia, and then in Toronto, where the disease first appeared in North America. Investigations of the Toronto hospitals showed lapses, in some cases simply because health care workers had no idea what they were dealing with. SARS wasn’t a global pandemic, but it was still a tragic story as dozens of doctors and nurses, many of them young, were struck down in the line of duty.Experts say this Wuhan virus is unlikely to turn into a global pandemic — and whether it becomes as tragic as SARS depends on cutting-edge science and simple sanitation. The fact that our world is full of potentially deadly viruses is scary, but we are not helpless in the face of them.To contact the author of this story: Faye Flam at fflam1@bloomberg.netTo contact the editor responsible for this story: Sarah Green Carmichael at sgreencarmic@bloomberg.netThis column does not necessarily reflect the opinion of Bloomberg LP and its owners.Faye Flam is a Bloomberg Opinion columnist. She has written for the Economist, the New York Times, the Washington Post, Psychology Today, Science and other publications. She has a degree in geophysics from the California Institute of Technology.For more articles like this, please visit us at bloomberg.com/opinionSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.

  • Business Wire

    Gilead Sciences to Release Fourth Quarter and Full Year 2019 Financial Results on Tuesday, February 4, 2020

    Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2019 financial results will be released on Tuesday, February 4, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s fourth quarter and full year 2019 financial results and will provide a business update.

  • Why This Biotech's Next Chapter Is 'TBD' Amid Deal-Making Dearth
    Investor's Business Daily

    Why This Biotech's Next Chapter Is 'TBD' Amid Deal-Making Dearth

    Gilead Sciences' next chapter is still murky, an analyst said Friday, noting a dearth of expected takeovers among biotech stocks during the annual J.P. Morgan Healthcare Conference.

  • Kyverna Therapeutics Secures $25 Million Series A Funding from Key Investors and Enters into Strategic Collaboration with Gilead Sciences
    PR Newswire

    Kyverna Therapeutics Secures $25 Million Series A Funding from Key Investors and Enters into Strategic Collaboration with Gilead Sciences

    Kyverna Therapeutics ("Kyverna"), a cell therapy company engineering a new class of therapies for serious autoimmune diseases, announced today that it has raised $25 million in a Series A investment from Vida Ventures and Westlake Village BioPartners, both of which were founding investors, as well as Gilead Sciences (NASDAQ: GILD). Proceeds from the financing will be used to advance Kyverna's therapeutic strategy which combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells at the root cause of inflammatory disease. Dominic Borie, M.D., Ph.D., has been appointed as Chief Executive Officer (CEO). Jeffrey Greve, Ph.D., will continue to serve as Kyverna's Chief Scientific Officer (CSO). Prior to Kyverna, Dr. Greve founded and served as CSO of Delinia, an autoimmune disease company acquired by Celgene in 2017.

  • Business Wire

    Gilead Sciences Licenses Portfolio of HIV Antibodies From The Rockefeller University

    Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the company has licensed The Rockefeller University’s portfolio of broadly neutralizing antibodies (bNAbs) against HIV, including the two clinical-stage agents 3BNC117 and 10-1074. These investigational agents have potential for use in HIV long-acting therapies for treatment and prevention, as well as cure strategies.

  • Gilead Stock Is Among The Biggest Biotech Stocks — But Should You Buy It?
    Investor's Business Daily

    Gilead Stock Is Among The Biggest Biotech Stocks — But Should You Buy It?

    Gilead is one of the biggest biotech companies. But recent news and earnings have been mixed. So, is Gilead stock a buy right now? Read on for a full analysis.

  • TheStreet.com

    Bristol-Myers, Gilead, Biogen, Other Drugmakers Increased U.S. List Prices on Jan. 1: Report

    Nearly all the price increases were less than 10%, with the median rise around 5%, a media report said.

  • More drugmakers hike U.S. prices as new year begins
    Reuters

    More drugmakers hike U.S. prices as new year begins

    Drugmakers including Bristol-Myers Squibb Co, Gilead Sciences Inc, and Biogen Inc hiked U.S. list prices on more than 50 drugs on Wednesday, bringing total New Year's Day drug price increases to more than 250, according to data analyzed by healthcare research firm 3 Axis Advisors. Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi SA were planning to increase prices on more than 200 drugs in the United States on Jan. 1.

  • 2019 Review: Most Favored Hedge Fund Stocks vs. Gilead Sciences, Inc. (GILD)
    Insider Monkey

    2019 Review: Most Favored Hedge Fund Stocks vs. Gilead Sciences, Inc. (GILD)

    It has been a fantastic year for equity investors as Donald Trump pressured Federal Reserve to reduce interest rates and finalized the first leg of a trade deal with China. If you were a passive index fund investor, you had seen gains of 31% in your equity portfolio in 2019. However, if you were an […]

  • Business Wire

    Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

    Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) announced today that Gilead Sciences K.K. (Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.

  • Business Wire

    Gilead Sciences to Present at the 38th Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2020

    Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Daniel O’Day, Gilead’s Chairman and Chief Executive Officer, will provide an overview of the company at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13 at 9:30 a.m. Pacific Time.

  • Business Wire

    China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment

    Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy.

  • Benzinga

    The Daily Biotech Pulse: Axovant Surges On Gene Therapy Study Results, FDA Approves Merck's Ebola Vaccine, Abeona Announces Offering

    The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs Dec. 19.) Acceleron Pharma Inc (NASDAQ: XLRN ) Ardelyx ...

  • Business Wire

    Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

    Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

  • Business Wire

    Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

    Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. While no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with a combination of the acetyl-CoA carboxylase (ACC) inhibitor firsocostat and the selective, nonsteroidal farnesoid X receptor (FXR) agonist cilofexor, compared with placebo in patients with advanced fibrosis.

  • Bristol-Myers wins $752 million in U.S. patent case against Gilead
    Reuters

    Bristol-Myers wins $752 million in U.S. patent case against Gilead

    A jury in Los Angeles awarded the damages after finding that Yescarta, a treatment sold by Gilead's Kite Pharma unit, infringed on a patent exclusively licensed by Bristol-Myers' Juno Therapeutics division. The patent at issue in the lawsuit, which Juno licenses from the Memorial Sloan Kettering Cancer Center in New York, relates to CAR T-cell immunotherapy for cancer.

  • Business Wire

    Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy

    Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

  • Business Wire

    Kite and Kiniksa Pharmaceuticals Announce Clinical Collaboration Evaluating Investigational Combination of Yescarta® and Mavrilimumab in Relapsed or Refractory Large B-Cell Lymphoma

    Kite, a Gilead Company (Nasdaq: GILD), and Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa") announced today that the companies have entered into a clinical collaboration to conduct a Phase 2, multicenter study of mavrilimumab, an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Kite will be the sponsor of this study and will be responsible for its conduct.

  • China’s Curing Cancer Faster and Cheaper Than Anywhere Else
    Bloomberg

    China’s Curing Cancer Faster and Cheaper Than Anywhere Else

    (Bloomberg) -- Zhang Haitao was a basketball-loving teenager who dreamed of going to a specialized sports high school when he got a pain in his right arm that just wouldn’t go away. It turned out to be acute lymphoblastic leukemia.The discovery set Zhang and his family, from a village deep in the mountains of southwestern China's Sichuan province, on a journey familiar to most cancer patients — a revolving door of hospital visits, blood tests and three rounds of chemotherapy. It was then that Zhang’s doctor suggested a last-ditch option: an experimental gene therapy being trialed by a Chinese startup called Gracell Biotechnology Ltd.After spending three weeks in the hospital in May — during which white blood cells were removed from his body, genetically engineered, and then infused back in — an analysis of Zhang’s bone marrow in June showed his body was clear of cancer.Seven months later, monthly medical tests conducted at a hospital in the nearby Chinese metropolis of Chongqing show he remains cancer free. “I don’t remember much about the treatment as I had a fever throughout,” said Zhang, who’s now almost 16 and spends his days playing video games and texting his friends. “It seems like a new solution that will give people hope.”Read more about how China is overhauling its healthcare systemThe therapy Zhang received was Chimeric Antigen Receptor-T cells, known as CAR-T, and it’s being hailed as one of the most exciting developments in the quest to cure cancer. First developed by Israeli scientist Zelig Eshhar in the 1980s, CAR-T re-works the genes of the body’s own immune cells so that they actively seek out and destroy cancer cells. While it’s been embraced by researchers and drugmakers around the world, perhaps nowhere is CAR-T having more impact — and being pushed dangerously close to its limits — than in China, home to the world’s biggest cancer population and some of the most ambitious experiments.CAR-T works by supercharging T-cells, the body’s main line of defense against disease, so that they latch onto and destroy cancer. In clinical trials, leukemia patients who failed to respond to other therapies have shown remission rates of over 90% within two months of treatment.Though drug giants Novartis AG and Gilead Sciences Inc. have been marketing CAR-T globally since 2017, it’s expensive. The process of engineering an individual’s cells in a laboratory and then replicating them has also meant that some patients with more aggressive cancers can die waiting for treatment.That’s where Gracell’s therapy was revolutionary. Instead of the two to three weeks taken by current treatments from American and European drug makers, the Shanghai-based company — set up by a group of veteran Chinese cell-therapy researchers — is churning out cancer-killing immune cells overnight.And they’re doing it much cheaper in some cases than global pharmaceutical giants. Gracell has developed a process using genetic engineering that speeds up the cell production stage, according to founder William Cao Wei. Gracell plans to price its CAR-T treatment for about 500,000 yuan ($71,000), well below the $475,000 price tag for Novartis’ Kymriah, the Swiss company’s CAR-T therapy used to treat the type of blood cancer that Zhang had. A similar treatment from Gilead, based in Foster City, California, costs $373,000.The aging population and a raft of lifestyle factors mean that more new cancer patients are emerging in China than anyplace else in the world, giving the country a significant stake in the global fight to find a cure. Emboldened by the government’s push to become a scientific superpower and to dominate the field of genetics, Gracell and other Chinese biotech startups are racing ahead, with China likely to approve CAR-T for widespread use as early as next year. Up for grabs is a market for cancer drugs and experimental treatments that has exploded to $133 billion a year worldwide, according to life sciences researcher Iqvia Institute.“There can be both cooperation and competition between us and CAR-T developers in developed markets,” said Cao, who is also Gracell’s chief executive officer. “But there will definitely be competition.” That drive to forge ahead — and in front — can be seen in the way China is approaching regulation of CAR-T. The country is weighing new rules that would loosen oversight of the revolutionary technology, allowing academic ethics committees within hospitals to approve new CAR-T treatments and then administer them to patients for a fee.That would markedly loosen China’s current framework, which is presently in line with the approach taken by regulatory bodies like the U.S Food and Drug Administration and the European Medicines Agency. These entities are the sole authorities in their jurisdictions that evaluate and approve all CAR-T therapies before they are cleared for public use.There is concern among researchers, regulatory experts and drugmakers themselves that allowing hospitals to market treatments for a fee could cause profit-making to trump ethical considerations. In a 2016 case widely reported in the Chinese media, a 22-year-old college student with a rare type of tissue cancer called synovial sarcoma died after going through an experimental cell therapy at a Beijing hospital.“Hospitals can become both players and referees at the same time”Before his death, the patient posted an essay online claiming the hospital had falsely advertised the treatment’s effectiveness, and that Chinese search engine Baidu Inc. had displayed the hospital’s advertising so that it appeared like a credible search result rather than a paid commercial. The essay went viral and sparked an outcry on Chinese social media over the ethics of private hospitals and the regulation of therapies for serious illnesses.Censured by the Cyberspace Administration of China, Baidu responded by restricting the number of sponsored posts to 30% of a results page, and established a 1 billion yuan fund to fight fraud. The hospital did not respond to requests for comment.It’s not the only death allegedly linked to genetic cell therapy in China. Last year, a hospital in the eastern city of Xuzhou was sued over the death of a lymphoma patient who died after receiving a CAR-T treatment. The patient developed severe side effects, including bleeding within the abdomen. The patient’s family argued that the treatment led to his death, but the hospital and doctor said it was the result of late-stage cancer. A court is yet to rule on the case.China’s proposed new framework is reminiscent of its wider approach to the regulation of science, an area President Xi Jinping has prioritized as part of his ambition to cement the country as a world power.The research of He Jiankui, an American-educated Chinese scientist whose revelation last year that he’d edited the genes of twin baby girls ignited a global firestorm, was signed off by the ethics committee of a Shenzhen hospital. The experiment, which He claimed made the twins immune to HIV, wasn’t backed by peer-reviewed data and still hasn’t been verified. Scientists around the world have condemned it as an irresponsible use of a technology that has the capacity to alter the very building blocks of life. The long-term effects of Crispr, the gene-snipping tool used by He and embraced by Chinese researchers, are also yet to be fully understood.China’s new draft rules on CAR-T could give rise to the same scenario, critics say.There’s no guarantee that the hospital committees have the qualifications to evaluate such a complicated therapy, said Tao Xin, a Washington, D.C.-based lawyer at Hogan Lovells LLP who specializes in the health-care regulatory law of both the U.S. and China.“The proposal indicates that hospitals can charge a fee for the therapy, in addition to approving its own therapy,” he said. “With these two combined, are we going to see a replay of the 2016 incident? If there’s money to be made and I get to decide whether to do it or not, that’s really controversial.”Read about how Crispr is being used in China’s quest to make a super pigGracell’s Cao is also critical of the new framework as it removes the role of an independent entity that evaluates the therapy’s safety and efficacy: “Hospitals can become both players and referees at the same time.”Novartis and Gilead declined to comment on China’s regulatory plans, while a spokesman for the National Health Commission, the body in charge of governing the country’s health sector, said that the proposed new rules are still under discussion.Read about how Chinese parents are using DNA tests to map out their children’s livesMeanwhile, Chinese companies are racing ahead on CAR-T and attracting hundreds of millions of dollars from investors like Singapore’s sovereign wealth fund Temasek Holdings Pte Ltd, as well as global pharmaceutical giants. Venture capital investment in Chinese biotech firms climbed to $17.6 billion last year, quadruple the amount from 2015, according to consultancy ChinaBio LLC. Gracell — which counts Temasek and Lilly Asia Ventures, the venture capital firm spun off from Eli Lilly & Co. as investors — says 32 of the 35 patients it’s enrolled in its China-based trials over the past year have gone into complete remission “with minimal residual disease tested negative” four weeks after the CAR-T infusion — a clinical term that basically means there was no evidence of disease remaining in their bodies, the highest possible efficacy level for a therapy.Other Chinese startups like Nanjing Legend, a unit of Hong Kong-listed Genscript Biotech Corp., and U.S.-listed Cellular Biomedicine Group Inc., have developed similar capabilities.In 2018, Novartis paid $40 million for a 9% stake in Shanghai-based Cellular Biomedicine, and will use their cell therapy facility to manufacture its Kymriah treatment, which is currently being assessed for approval by China’s drug regulator. The startup is also developing its own CAR-T therapies and testing their potential against solid tumors, not just blood cancers. Chief Executive Officer Tony Liu Bizuo said Cellular Biomedicine’s digitized and automated process cuts the cell engineering time from four weeks to less than 10 days.Cellular Biomedicine is now mulling building a bigger cell production facility with the Shanghai government, as demand for cell therapy grows and on expectations more commercial CAR-T treatments will be approved in China in the coming years. In a sign of the support startups are getting from the authorities, the city’s government has earmarked a 4 million square feet space for cell therapy research. Of the 21 cell therapies currently in clinical trials approved by China’s drug regulator, 11 are being conducted in the lab, which is fast becoming the nation’s CAR-T Ground Zero.The next frontier is to make CAR-T as accessible as any other drug, and Chinese startups are at the leading edge. Dubbed “universal CAR-T,” this involves finding a way to take T-cells from healthy people and engineering them so that they can be infused into any cancer patient. Gracell is studying the use of donor white blood cells, marking a step toward that goal. Other startups like French company Cellectis SA are also racing to make universal CAR-T a reality.“I’m very impressed with the pace of technological progress in China and the expansion of CAR-T research coming so rapidly,” said Bruce Levine, a professor specializing in cancer gene therapy at the Perelman School of Medicine at the University of Pennsylvania.“We all want these therapies to move fast and some are very good, but we need to be aware that some could be moving too fast for their expertise, even if they have very good intentions,“ he said.Read about how a Chinese genetics giant wants to tailor drugs to people’s DNAAfter a year in and out of hospital, Zhang, the teenage cancer patient in Chongqing, is starting to make plans for the future. If it wasn’t for the leukemia, he’d be in his first year of high school now.“I don’t think I can go to sports school anymore, but I hope to learn a professional skill,” said Zhang, who’s now a foot taller than his aunt, Chen Chunhua, his primary caregiver. “I want to grasp this chance I have.”While China’s approach to CAR-T may be criticized as moving too fast, Chen, who left her job at a ceramics factory to care for Zhang when he got sick, is thankful he had access to the treatment, which wouldn’t have been possible in China had the boy fallen ill just a year earlier.“I’m so happy we had this option within China,” she said. “It really helps to lessen our burden.”  \--With assistance from Dong Lyu.To contact the editor responsible for this story: Rachel Chang at wchang98@bloomberg.net, Anjali CordeiroFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.

  • Business Wire

    Kite and the CIBMTR® Present Positive Findings From Real-World Use of Yescarta® (Axicabtagene Ciloleucel) in Relapsed or Refractory Large B-Cell Lymphoma

    Kite, a Gilead Company (Nasdaq: GILD), and the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW), today announced findings from an ongoing post-marketing study evaluating the safety and efficacy of Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma. In this analysis, efficacy and safety of Yescarta were comparable to that observed in the ZUMA-1 trial, despite a larger proportion of older, more difficult-to-treat patients in the real-world setting. The findings were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, held in Orlando from December 7–10, 2019.

  • Business Wire

    Kite Presents Positive Results From Pivotal ZUMA-2 Trial in Relapsed or Refractory Mantle Cell Lymphoma

    Kite, a Gilead Company (Nasdaq: GILD), today announced primary results from ZUMA-2, a global, multicenter, single-arm, open-label Phase 2 study of KTE-X19, an investigational CD19 chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma (MCL). After a single infusion of KTE-X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. These findings were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7–10, 2019.

  • Reuters

    Half of lymphoma patients alive three years after Gilead cell therapy treatment -study

    Nearly half of lymphoma patients treated with Gilead Sciences Inc's Yescarta were alive at least three years after a one-time infusion of the CAR-T cell therapy, according to data presented on Saturday. Out of 101 patients teated with Yescarta for an aggressive blood cancer known as refractory large B-cell lymphoma in the study, 47 were still alive at least three years later, the data presented at the American Society of Hematology meeting in Orlando showed. "We are delivering towards our goal of potentially life-saving therapy for many patients who previously faced limited treatment options," Christi Shaw, chief executive of Gilead's Kite unit, said in a statement.

  • Business Wire

    Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment

    Kite, a Gilead Company (Nasdaq: GILD), today announced new data from the ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma. These results included updated overall survival data from the pivotal phase 2 study after three years following a single infusion of Yescarta, as well as an analysis from a separate safety management cohort of patients receiving early steroid intervention for cytokine release syndrome (CRS) and neurologic events. The data were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7–10, 2019.