|Bid||72.90 x 800|
|Ask||73.19 x 900|
|Day's range||71.91 - 75.39|
|52-week range||60.89 - 85.97|
|Beta (5Y monthly)||0.99|
|PE ratio (TTM)||17.26|
|Forward dividend & yield||2.72 (3.68%)|
|Ex-dividend date||11 Mar 2020|
|1y target est||N/A|
Gilead (GILD) asks the FDA to revoke the Orphan Drug designation granted to its experimental drug, remdesivir, for the treatment of COVID-19.
Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels predicts the most vulnerable will begin to receive vaccines within 12 months to prevent COVID-19.
(Bloomberg Opinion) -- The need for any kind of treatment to help stem the coronavirus outbreak is acute as cases and hospitalizations continue to mount. But there's a strong need to balance urgency and evidence.President Donald Trump's cheerleading of chloroquine and its derivative hydroxychloroquine — older malaria drugs with limited evidence of efficacy in Covid-19 — is arguably dangerous. As he touts the drugs in press conferences, people are reportedly poisoning themselves via self-administration and hoarding it to create hazardous shortages, making the prudent use and evaluation of it as a treatment more difficult. That said, sitting on medicines while they make their way through a lengthy trial and regulatory process is also a mistake. The worst of the pandemic will arrive soon in parts of the U.S. With vaccines and novel therapeutics far away, inaction has a high human cost.A potential solution is innovation, not just in cleverly repurposing old drugs, but in how we test whether they work. While cautious use of existing treatments for the sickest patients should continue, simultaneously running a wide variety of ambitious clinical trials will help get more drugs to more patients and could help rapidly confirm what works best, the sooner we can generate data that helps doctors give the right drugs to the right people, the better.Excitement about chloroquine and hydroxychloroquine isn't entirely baseless. Other countries have seen enough promise to include it in treatment guidelines. While a widely covered positive French trial that combined hydroxychloroquine with an antibiotic was small and flawed, the results warrant further study. The fact that these are cheap generics with a long history of use could make them especially helpful. On the other hand, this group of medicines can have side effects, and an abstract for a Chinese trial detailed in a recent research note by Evercore ISI analyst Umer Raffat describes poor results for hydroxychloroquine in mild patients. We know far too little to put too many eggs in any one basket.Traditional trials are rigorously designed, generally run without deviation from the initial plan, and are only analyzed once the data is ready according to a pre-specified plan. Such trials are standard for a reason; it's a battle-tested process and statistically reliable. But it can be slow and inflexible, which calls for new tools such as so-called adaptive trials that evolve based on incoming data. These more recently developed tests let researchers use data from their ongoing trials to count out treatments or doses that aren't working and add new arms based on emerging evidence. They can also allocate more patients to regimens that are looking good, and focus recruiting on patients most likely to benefit.Well-run adaptive trials can be smaller, faster, and more ethical, all features that make them well suited to this moment. And they are growing in popularity. Some researchers and parts of the drug industry have been slow to change, however. Now is the time to push the envelope.The World Health Organization is taking a positive step with a large and rapidly designed adaptive trial testing multiple coronavirus approaches, including chloroquine and hydroxychloroquine, Gilead Sciences Inc.'s remdesivir and an HIV drug. The worthy priority of the trial is simplicity; it aims to collect data from as many places as possible, without strict requirements that overwhelm health workers. It's a crucial effort and a good blueprint. It needs to be supplemented by further similar studies in the U.S. and around the world to broaden access and answer emerging questions. The WHO trial doesn't include every promising treatment, and the HIV drug it is testing has already failed to show a benefit in some small trials. The stage of infection, symptoms, age, and pre-existing conditions will likely create variation in how people respond to treatments and what they need, further underscoring the need for a wide variety of flexible designs. It'd be a good thing if the president used his office to support responsible efforts to speed development. But perhaps his cheering section should be behind the scenes, rather than behind the podium.This column does not necessarily reflect the opinion of Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.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.
Gilead Sciences Inc said on Sunday it was temporarily putting new emergency access to its experimental coronavirus drug remdesivir on hold due to overwhelming demand and that it wanted most people receiving the drug to participate in a clinical trial to prove if it is safe and effective. The spread of the virus in Europe and the United States has "flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic," it said. Gilead said it would keep processing previously approved requests.
The FDA approves Gilead's (GILD) sNDA for Epclusa to treat chronic hepatitis C infection in children aged six years and above or weighing at least 17 kg.
The worldwide coronavirus crisis showed no signs of letting up on Thursday, as Italy’s death toll surpassed China’s.
(Bloomberg Opinion) -- As the coronavirus crisis has unfolded, we’ve seen a flood of announcements from drug companies touting potential treatments for the still incurable disease. Many have come from biotechnology companies that have never successfully developed a drug, let alone purpose-built one for an outbreak. Regeneron Pharmaceuticals Inc.'s announcement Tuesday that its development efforts are ahead of schedule — so much so that it may be able to start human trials in early summer — is an exception that should provoke measured optimism.There's still a long road ahead and a lot of uncertainty. Even in a best-case scenario, a drug won't be tested for months and broad availability is even farther away. But if Covid-19 sticks around, there's at least a chance a Regeneron drug will be a tool used to fight it. In addition to developing blockbuster medicines, Regeneron has a demonstrated ability to respond to outbreaks.The company’s efforts are centered on using mice engineered with human-like immune systems and rapidly developing the antibodies they generate into human medicines. The company created a trial-ready Ebola cocktail in about a year in response to a 2014 flareup of the disease, but the drug didn’t make it to market in time to help before the outbreak subsided. The medicine stayed on the shelf until Ebola emerged again in 2018, and it was sent to Africa to for testing alongside several other drugs. Only 29% of those who took Regeneron's drug died throughout the trial, compared with a mortality rate of about 50% for people who took two less effective medicines. One of the medicines it beat by a significant margin was Gilead Sciences Inc.'s remdesivir, which has shown early promise as a Covid-19 treatment. An additional advantage of Regeneron's approach is that it's intended to lead to a drug that could serve as both protection against the virus and treatment for active cases. This duality may help it get to patients faster; acute treatments have a lower safety bar and require less study than medicines intended for extensive protective use. The company's timeline for a Covid-19 treatment is faster than what it's managed in the past; that’s in part because its team is working with more experience. Still, there's no guarantee of success, and what is considered “rapid” by the standards of drug development will still feel slow as U.S. cases grow in the next few weeks. A best-case scenario requires Regeneron to hit multiple ambitious targets, including that the drug will work when others developed over a more extended period fail, that it will get the nod from regulators, and that the company will be able to quickly build the manufacturing capibility to produce it. If every mark is hit, the drug could conceivably see limited use sometime in the fall. The more likely scenario — especially when it comes to crucial preventative use — is that it takes longer. That may not seem like much of a win as cases mount every day. Keep in mind, however, that the most ambitious timeline for a vaccine is 12 to 18 months, and that the most promising interim options are repurposed. A novel remedy any time this year would still be unprecedented, and with many drug companies having moved away from infectious diseases, it may be essential. This column does not necessarily reflect the opinion of Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.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.
Gilead (GILD) leads the race of companies developing treatments for coronavirus with experimental candidate, remdesivir, showing promise.
The outbreak of COVID-19 has brought the volatile biotech sector under the spotlight as both large and small companies rush to develop treatments and vaccines to combat this pandemic.
Gilead (GILD) announces long-term results from the DISCOVER study, which showed that Descovy is effective for HIV prevention with non-inferior efficacy to Truvada.
Increasing alarm over the coronavirus’ relentless spread outside of China sparked another global sell-off, with new cases and deaths on the rise across the world.
Stocks continue to whipsaw. Here is one thing investors really want to see before stepping back into stocks.