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Great read. Positive news for GILD future my friend
Shots made by Moderna Inc. and the National Institutes of Health and by China's Sinovac work in different ways. Moderna plans a study of 30,000 U.S. volunteers while researchers in Sao Paulo, Brazil, will recruit 9,000 people to receive Sinovac shots.
About a dozen candidates are in early stages of human testing in the global race for a vaccine.
The first experimental COVID-19 vaccine in the U.S. is on track to begin a huge study next month to prove if it really can fend off the coronavirus, while hard-hit Brazil is testing a different shot from China.
Where to do crucial, late-stage testing and how many volunteers are needed to roll up their sleeves are big worries for health officials as the virus spread starts tapering off in parts of the world.
Moderna Inc. said Thursday the vaccine it is developing with the National Institutes of Health will be tested in 30,000 people in the U.S. Some will get the real shot and some a dummy shot, as scientists carefully compare which group winds up with the most infections.
With far fewer COVID-19 cases in China, Sinovac Biotech turned to Brazil, the epicenter of Latin America's outbreak, for at least part of its final testing. The government of São Paulo announced Thursday that Sinovac will ship enough of its experimental vaccine to test in 9,000 Brazilians starting next month.
If it works, "with this vaccine we will be able to immunize millions of Brazilians," said São Paulo´s Gov. Joao Doria.
Worldwide, about a dozen COVID-19 potential vaccines are in early stages of testing. The NIH expects to help several additional shots move into those final, large-scale studies this summer, including one made by Oxford University that's also being tested in a few thousand volunteers in Brazil.
There's no guarantee any of the experimental shots will pan out.
But if all goes well, "there will be potential to get answers" on which vaccines work by the end of the year, Dr. John Mascola, who directs NIH's vaccine research center, told a meeting of the National Academy of Medicine on Wednesday.
Vaccines train the body to recognize a virus and fight back, and specialists say it's vital to test shots made in different ways — to increase the odds that at least one kind will work.
Sinovac's vaccine is made by growing the coronavirus in a lab and then killing it. So-called "whole inactivated" vaccines are tried-and-true, used for decades to make shots against polio, flu and other diseases — giving the body a sneak peek at the germ itself — but growing the virus is difficult and requires lab precautions.
The vaccine made by the NIH and Moderna contains no actual virus. Those shots contain the genetic code for the aptly named "spike" protein that coats the surface of the coronavirus. The body's cells use that code to make some harmless spike protein that the immune system reacts to, ready if it later encounters the real thing. The so-called mRNA vaccine is easier to make, but it's a new and unproven technology.
Neither company has yet published results of how their shots fared in smaller, earlier-stage studies, designed to check for serious side effects and how well people's immune systems respond to different doses.
Even before proof that any potential vaccine will work, companies and governments are beginning to stockpile millions of doses so they can be ready to start vaccinating as soon as answers arrive.
In the U.S., a program called "Operation Warp Speed" aims to have 300 million doses on hand by January. Under Brazil's agreement with Sinovac, the Instituto Butantan will learn to produce the Chinese shot.
We’ll see how the opening goes!!!!!!
Absolutely fantastic DD my friend
I believe you are correct $$$$$$$
Bought and sold HTZ on the Dow around 18k made good $$$$$ I know this has the same potential $$$$$$$ just might have to sit for a little bit. I’m ok with that. Best of trades my friend
$$$$$$$$$$$$$$$$$$
GREEN on a Monday!!!!!!! I’ll take it $$$$$
Welcome my friend, glad your here!!!!!!! Your going to do great hear. Just be patient
Things are definitely looking like they are on CRUISE Control $$$$$$$$$
Very soon my friend. We’re so close $$$$$$$
Been here since 7 plus my friend. These are still good prices with lots of room to run. Best of trades either way
It’s been showing up on multiple boards. Lots of eyes are on us $$$$$$)
In premarket trading on the stock market today, GILD stock popped 4% near 79.80. But AstraZeneca stock slipped 2.2% near 52.70.
The reports emerged over the weekend. Pharma giant AstraZeneca approached Gilead a month ago about a potential merger, according to Bloomberg, which cited people familiar with the matter. There have been no formal talks.
If successful, the tie-up would be the biggest health care deal on record since Bristol Myers Squibb (BMY) spent $74 billion last year to acquire biotech company Celgene.
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Shares of GILD stock have struggled for years amid a decline in its hepatitis C treatment franchise. Now, Gilead is making a big push into treating HIV and cancer. The biotech also makes a coronavirus treatment which has emergency authorization in the U.S.
Breaking 30s this week and building a stronger base for USO $$$$$$$
Pre market 25 plus $$$$$$$$$$$
When Dr. Anthony Fauci speaks, people listen. The director of the National Institute of Allergy and Infectious Diseases (NIAID) quickly became a top spokesperson for the U.S. effort to fight the COVID pandemic earlier this year.
There's one company that Fauci has singled out among the several that are developing COVID-19 vaccine candidates. That drugmaker is Moderna (NASDAQ:MRNA).
And when The New York Times reported a few days ago that the Trump administration has picked five COVID-19 vaccines to receive substantial financial support of the U.S. government, there was one company mentioned first. You guessed it... Moderna.
Is Moderna really the de facto leader in the COVID-19 vaccine race? It's complicated.
COVID-19 vaccine bottles with two bottles lying on their sides
IMAGE SOURCE: GETTY IMAGES.
First mover among several
On March 16, Moderna became the first to begin a phase 1 clinical study evaluating a COVID-19 vaccine candidate in humans. But it was followed a week later by Chinese drugmaker CanSino Bio.
Inovio wasn't too far behind. The clinical-stage biotech began a phase 1 study of its experimental COVID-19 vaccine on April 6.
The University of Oxford dosed the first patients in a phase 1 study of its COVID-19 vaccine candidate on April 23. By the end of April, big British drugmaker AstraZeneca (NYSE:AZN) announced that it was partnering with Oxford on the development and commercialization of the vaccine.
Pfizer (NYSE:PFE) and its partner, BioNTech (NASDAQ:BNTX), weren't far behind. The two companies kicked off the phase 1 portion of a phase 1/2 clinical study of a COVID-19 vaccine candidate initially developed by BioNTech on May 5.
Novavax (NASDAQ:NVAX) jumped into the race on May 25. The clinical-stage biotech also initiated the phase 1 part of a phase 1/2 clinical study.
Others are in hot pursuit. Johnson & Johnson expects to begin a clinical study of its COVID-19 vaccine candidate by September. Merck, Sanofi, and GlaxoSmithKline are gearing up to begin clinical testing of their experimental vaccines.
A neck-and-neck race
Although Moderna was the first to begin clinical testing of a COVID-19 vaccine candidate, is it still in first place? That's a tough call. It's definitely a neck-and-neck race.
Moderna expects to begin a phase 3 study of its COVID-19 vaccine in July. But Chinese drugmaker CanSino could begin its late-stage study around the same time.
The AstraZeneca-Oxford team is certainly in the running for the lead position as well. The partners began enrolling for a phase 2/3 clinical study in late May. They haven't stated exactly when the clinical trials will wrap up because of the uncertainty about how long it will take for some participants to develop COVID-19. Results could be available within two months of the study kick-off or up to six months.
Gloved hand holding COVID-19 vaccine syringe
IMAGE SOURCE: GETTY IMAGES.
What's harder to determine
It's pretty easy to compare the timelines of each of the companies developing COVID-19 vaccine candidates. What's much harder is to try to determine which of these vaccines have the best chance of success.
The White House chose the vaccines being developed by Moderna, AstraZeneca-Oxford, Pfizer-BioNTech, J&J, and Merck as the most promising candidates. Does this mean that these vaccines are truly the most likely to be successful? Not necessarily. For one thing, it's a mystery why the Trump administration picked J&J and Merck over others that are farther along (namely, Novavax and Inovio).
Another organization that's trying to identify the COVID-19 vaccine candidates with the most promise is the Coalition for Epidemic Preparedness Innovations (CEPI). The nonprofit organization was founded by the Bill and Melinda Gates Foundation, the governments of India and Norway, the Wellcome Trust, and the World Economic Forum. It's also funded by other governments across the world as well as by private sector companies.
CEPI has funded several COVID-19 vaccine candidates so far. But the organization has invested the heaviest in the vaccines being developed by Novavax and AstraZeneca.
A tricky three-letter word
At least when it comes to the COVID-19 vaccine race, referring to Moderna (or any other company) as the leader is probably premature. "The" is a tricky three-letter word in this case. It's better to instead to view Moderna as a leader in the development of a COVID-19 vaccine.
But we should also view several others as leaders in developing COVID-19 vaccines. I'd put AstraZeneca and the University of Oxford, CanSino Bio, and Novavax on the list for sure. And I wouldn't rule out the Pfizer-BioNTech partnership or Inovio.
What about J&J, Merck, Sanofi, and GlaxoSmithKline? These big pharmaceutical companies certainly have considerable vaccine expertise and the financial resources to quickly advance their COVID-19 vaccine candidates. Because none of them have begun clinical trials yet, I'd be hesitant to refer to them as leaders at this point. However, that could change in the near future.
I fully expect that there will eventually be multiple vaccines that prove to be safe and effective. Moderna is getting the most attention right now, but my view is that the biotech will have to share the limelight.
Shares of Gilead Sciences Inc. GILD, -1.01% rose 4.6% in premarket trading Monday, after Bloomberg reported over the weekend that U.K. drugmaker AstraZeneca PLC AZN, -0.03% AZN, -2.42% made a preliminary approach regarding a potential merger, although the report said the companies weren't in formal talks and Gilead was not currently interested in selling or merging. On Monday, The Times of London reported that AstraZeneca abandoned the tentative interest in Gilead. AstraZeneca's stock fell 2.5% ahead of the open. Gilead makes the experimental COVID-19 treatment remdesivir, and AstraZeneca said last week that it has started producing the University of Oxford's potential COVID-19 vaccine. As of Friday's close, Gilead's market capitalization was $96.24 billion, according to FactSet, and AstraZeneca had a market cap of $141.33 billion. Gilead's stock has gained 18.1% year to date through Friday, while AstraZeneca shares have advanced 8.0% and the S&P 500 SPX, +2.62% has slipped 1.1%.
American Airlines (AAL) - Get Report reportedly has detailed severance packages for high-level employees if they are laid off when the terms of federal aid expire in the fall, people familiar with the matter said.
The severance packages for upper management include around nine months of pay and a little more than two years of healthcare coverage for at least some of the employees at the director level and above, CNBC reported, citing one of the people.
American Airlines indicated last month it plans to cut its management and support staff by about 30% to slash costs as the coronavirus pandemic has severely curtailed air travel.
Also not a Pumer Rookie
Great DD. Could mean HUGH potential with the right PR release!!!!
Great find my friend!!!!!!
True DD
Not a silly opinion or made up rule!!!!!
The COVID-19 pandemic hit U.S. airline stocks hard earlier this year: none more so than Spirit Airlines (NYSE:SAVE). Shares of the budget carrier changed hands for nearly $45 as recently as mid-February. Within weeks, Spirit Airlines stock had plunged into single-digit territory, hitting an all-time low of $7.01 on March 19.
As recently as May 15, Spirit Airlines stock closed at $8.01, within striking distance of its mid-March low. But the stock has rallied furiously ever since. Over the following six trading days, shares of the budget carrier gained more than 50%, reaching $12.31. The next seven trading days were even more spectacular, as the stock rallied another 71%, reaching $21.02 by the end of the day on Thursday. The stock then skyrocketed as much as 23% on Friday, topping out at $25.94, before retreating to end the day at $22.62. Spirit Airlines stock has now more than tripled off its 2020 low.
SAVE Chart
DATA SOURCE: YCHARTS.
There were good reasons for Spirit Airlines' recent rally, as investors have been too pessimistic about the company's prospects in recent months. That said, further gains will be harder to come by, and will depend on Spirit's ability to resume its growth and boost its pre-tax margin back into double-digit territory.
Air travel is recovering (slowly)
Sequential improvements in air travel demand are a big reason why Spirit Airlines stock and other airline shares are rallying. On Thursday, 391,882 people passed through TSA checkpoints, the highest daily total since March. At the worst point of the crisis, the TSA was only processing about 90,000 people per day.
Among U.S. airlines, Spirit Airlines is relatively well positioned to capitalize on improving demand. It has the lowest unit costs in the U.S. airline industry and benefits from substantial ancillary revenue streams. That means Spirit can be profitable while offering extremely low fares to appeal to budget-conscious consumers. Additionally, it primarily serves leisure travelers, and leisure demand is returning much faster than business travel. Lastly, Spirit has a broad point-to-point route network, which should enable it to be nimble with respect to restoring capacity based on how quickly particular markets are recovering.
There are already signs of improvement. In Fort Lauderdale -- its biggest base of operations -- Spirit plans to operate 70% of its pre-coronavirus capacity in July, compared to less than 10% in May. In Las Vegas (another key focus city), Spirit Airlines plans to increase service to 39 flights a day in July, up from just five daily flights a few weeks ago.
A yellow Spirit Airlines jet parked at an airport gate
SPIRIT AIRLINES WILL RESUME MANY OF ITS ROUTES BY JULY. IMAGE SOURCE: SPIRIT AIRLINES.
On the other hand, while demand for air travel is starting to return, TSA screenings were still down 85% year over year on Thursday. That's a big improvement from down 96% in mid-April, but the industry is still in the early innings of the recovery. Despite its low cost structure, Spirit Airlines has significant fixed costs: particularly interest expense and lease liabilities. Until it can fully utilize its assets with reasonable fares and high load factors -- which won't happen until demand gets much closer to 2019 levels -- there's no way that it can return to profitability.
Don't count on a straight-line recovery
The outlook for Spirit Airlines stock depends in large part on the future pace of the recovery. Many investors appear to be betting on a steady continuation of the past month's momentum. In such a "straight-line" recovery scenario, air travel demand would rebound to more than a third of 2019 levels by the end of the summer, about two-thirds of 2019 levels by year-end, and would fully recover by this time next year.
However, the recovery is unlikely to be this smooth. July is the peak of the summer travel season. Furthermore, people who are less worried about the pandemic have been eager to get back to traveling. For the recovery to continue at a rapid pace beyond the summer, Spirit Airlines and its peers will need to attract customers outside of peak vacation season and will need to convince people who have been more worried about the virus to start flying again.
An even bigger risk is the possibility of a second wave of the pandemic later this year, leading to new travel restrictions. COVID-19 cases have started rising again in many of the states that were quick to reopen their economies, according to The New York Times, highlighting this risk.
Spirit's market cap has mostly recovered
Even after the recent rally, Spirit Airlines stock sits about 50% below its 2020 highs. That would seem to indicate a significant discount to account for the risk of a slow profit recovery. However, this doesn't reflect the full extent of the recovery in Spirit Airlines' valuation.
A month ago, Spirit Airlines issued both equity and convertible debt to shore up its balance sheet. It sold 20.125 million shares for $10 each and $175 million of convertible debt that can be converted to stock at a price of approximately $12.75 per share. Together, these actions netted $362 million for the company, buying much-needed time for business to improve.
Assuming immediate conversion of the convertible debt, Spirit Airlines' share count would now stand at 102.4 million, compared to 68.5 million previously. This 49% increase in the share count means that at Spirit Airlines stock's Friday intraday high of $25.94, the company's market cap was within about 3% of where it stood in January.
Spirit Airlines stock still has plenty of long-term upside, assuming that business goes back to normal within two or three years and the airline becomes a high-growth company with solid margins once again. Yet this upside is now evenly balanced against the risk of the COVID-19 pandemic getting worse before it gets better, which could force Spirit to take on additional debt and dilute existing shareholders even further. Investors may find bigger bargains elsewhere.
Great find!!!!!!
Hahahahaha, great advice coming from...... ?
Exactly, been a LONG
Continue to b a LONG
Everything I post here is actually TRUE DD.... not opinions about my personal views on politics.
Bring something to the board that talks about SAVE and then you’ll get a response from me next time Rook
If u think I’m trying to dump this stock your ABSOLUTELY WRONG. I’ve been here since 9.30 I’m sending information on both sides and pros and cons of the hills and valley’s to try to help SOME who might not understand why the stock is moving North or a pullback. Get your facts Straight and bring something to the board other than your OPINION!!!!!
Good to see you posting here my friend
Shares of Aurora Cannabis (NYSE:ACB) surged 59% last month, according to data provided by S&P Global Market Intelligence. The marijuana producer delivered better-than-expected third-quarter results and entered a major new market.
So what
Aurora's shares rocketed higher on May 15, following the release of its fiscal third-quarter financial report. Its net revenue, excluding provisions, jumped 18% sequentially to CA$78.4 million, driven by strong growth in recreational and medical cannabis sales. That was well above the CA$66.7 analysts expected. The news is believed to have ignited a short squeeze; many short sellers who bet against Aurora's stock were likely forced to buy shares in order to close their positions, thereby helping to drive the price higher.
A rising stock chart superimposed on some cannabis plants.
AURORA CANNABIS STOCK ROSE SHARPLY IN MAY. IMAGE SOURCE: GETTY IMAGES.
The gains continued later in the month when Aurora struck a deal to enter the potentially massive U.S. cannabidiol (CBD) market. On May 20, the cannabis leader announced it would acquire Reliva, a top-selling CBD brand. Aurora said the deal would help to improve its profitability shortly after its expected closing in June, and investors cheered the news.
Now what
Despite its strong recent performance, Aurora Cannabis remains a high-risk stock. It's still unprofitable, and due to its dwindling cash reserves, Aurora will likely need to further dilute shareholders by selling more shares.
However, should it be able to achieve profitability sooner than expected, Aurora's positioning within the rapidly growing global cannabis market could make it an intriguing long-term investment.
Cruise ship stocks surged on Friday after a surprising jobs report boosted investors' hopes for a faster-than-expected economic recovery.
As of 1:30 p.m. EDT, shares of Carnival (NYSE:CCL), Royal Caribbean (NYSE:RCL), and Norwegian Cruise Line Holdings (NASDAQ:NCLH) were all up more than 20%.
So what
The U.S. economy added 2.5 million jobs in May, according to the Labor Department, which brought the unemployment rate down to 13.3%. That was in stark contrast to analysts' projections. Wall Street expected the economy to lose 8 million jobs, which would have increased the unemployment rate to nearly 20%.
These surprising job numbers ignited a sharp rally in the stock markets, with all of the major indexes enjoying gains of at least 2%. The news also helped to further the rally in travel-related stocks, which followed American Airlines' (NASDAQ:AAL) announcement on Thursday that it would increase its number of domestic flights in July due to a sharp rebound in passenger traffic in May.
Three cruise ships in clear blue water.
CRUISE SHIP STOCKS SOARED ON FRIDAY. IMAGE SOURCE: GETTY IMAGES.
Now what
A quicker economic recovery would certainly be beneficial to the cruise ship industry, which depends on customers having enough discretionary income to spend on vacations. And if people are willing to fly on planes during the coronavirus pandemic, as American Airlines' traffic metrics suggest, then they also may be willing to book cruises. That, too, bodes well for Carnival, Royal Caribbean, and Norwegian Cruise Line Holdings.
NV (Euronext & Nasdaq: GLPG) today announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA). The data from the double-blind, placebo-controlled, Phase 2 EQUATOR study and the EQUATOR-2 open-label extension study demonstrate filgotinib’s durable efficacy and consistent safety profile in people with active PsA, and showed rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe PsA. The new analyses were presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200605005485/en/
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Find Your Calm
"Despite existing treatments, people living with psoriatic arthritis can face challenging long-term symptoms including joint swelling and stiffness, pain and fatigue – all of which can significantly impact patients’ daily lives," said Mark Genovese, MD, Senior Vice President, Inflammation, Gilead Sciences. "These new analyses from the EQUATOR study program showed that patients with PsA who were treated with filgotinib achieved a sustained response. We look forward to advancing the pivotal Phase 3 PENGUIN clinical trial program to confirm the safety and efficacy of filgotinib as a potential treatment option for this patient population."
"The data from the Phase 2 program for filgotinib in psoriatic arthritis add to the growing body of evidence for the efficacy and safety profile of this investigational treatment," said Walid Abi-Saab, MD, Chief Medical Officer, Galapagos. "We are particularly encouraged by the innovative analysis of the impact of filgotinib at the molecular level, which indicates the drug is acting rapidly to reduce the hallmarks of inflammation in this condition."
Efficacy and Safety of Filgotinib in Patients with Active PsA: Subgroup Analyses from a Randomized, Placebo-Controlled, Phase 2 Trial (EQUATOR) (Poster #0343)1
In a new subgroup analysis of patients with active PsA in the 16-week EQUATOR Phase 2 trial, the effects of filgotinib on key efficacy endpoints were generally consistent across a range of patient subgroups, including sex, body mass index, disease duration, baseline disease severity, concurrent use of disease-modifying antirheumatic drugs and prior exposure to tumor necrosis factor inhibitors.
Filgotinib consistently demonstrated a statistically significant higher proportion of patients achieving ACR20 response compared with placebo across all subgroups. Similarly, filgotinib achieved a higher proportion of ACR50 response and Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity, compared with placebo, reaching statistical significance in most subgroups. Treatment differences for Disease Activity Index for Psoriatic Arthritis (DAPSA) consistently favored filgotinib, reaching statistical significance in most subgroups, as well. There were no clinically relevant differences when comparing response to filgotinib across subgroups.
Filgotinib demonstrated a consistent safety profile, and no new safety signals were identified in this study.
Long-Term Efficacy of Filgotinib in PsA: Week 52 Response Patterns from an Open-Label Extension (OLE) Study (EQUATOR-2) (Poster #0339)2
Nearly all (98.4 percent, 122/124) of the patients who completed the 16-week EQUATOR trial enrolled in the EQUATOR-2 OLE study. The median exposure to filgotinib in both EQUATOR and the OLE study was 66 weeks. An interim analysis at Week 52 demonstrated sustained efficacy with filgotinib across several measures of disease activity and treatment response in patients with active PsA.
The majority of patients who achieved minimal disease activity (MDA) and ACR50 response in the original EQUATOR trial maintained MDA and ACR50 at Week 52, and a proportion of non-responders in EQUATOR achieved these responses in the OLE study. In total, at Week 52 of the OLE study, 33.6 percent of patients achieved MDA response and 55.0 percent achieved ACR50 response in this observed case analysis. No new safety signals were observed.
Effect of Filgotinib on Inflammatory Biomarkers in Patients with Moderate to Severe PsA (Oral #0224)3
Finally, in a new biomarker analysis of samples from the EQUATOR trial, treatment with filgotinib demonstrated significantly greater reductions from baseline in levels of circulating biomarkers associated with PsA disease activity, compared with placebo. Filgotinib treatment reduced cytokines involved in both systemic inflammation, such as IL-6 and SAA, as well as psoriasis-associated pathology, such as IL-17AF and IL-12 p40, reflecting the improvements in clinical scores observed in EQUATOR. These findings are consistent with reduced disease activity in patients with PsA and suggest that filgotinib treatment leads to a sustained reduction of inflammation in PsA.
Filgotinib is an investigational agent and is not approved by the FDA or any other regulatory authority. For information about the clinical trials with filgotinib, visit www.clinicaltrials.gov.
About the Filgotinib Collaboration4
Gilead and Galapagos are collaborative partners in the global development and commercialization of filgotinib in RA and other inflammatory indications. The companies have multiple clinical study programs for filgotinib in inflammatory diseases, including the FINCH Phase 3 program in rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in small bowel and fistulizing Crohn’s disease. More information about clinical trials with filgotinib can be accessed at: www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
About Galapagos
Galapagos NV (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving ?lgotinib and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines. Further, it is possible that the parties may make a strategic decision to discontinue development of ?lgotinib, and as a result, ?lgotinib may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to di?er materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Galapagos Forward-Looking Statement
This release may contain forward-looking statements with respect to Galapagos, including statements regarding Galapagos’ strategic ambitions, the mechanism of action and potential safety and efficacy of filgotinib, the anticipated timing of clinical studies with filgotinib and the progression and results of such studies. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of filgotinib due to safety, efficacy or other reasons), Galapagos’ reliance on collaborations with third parties (including its collaboration partner for filgotinib, Gilead), and estimating the commercial potential of Galapagos’ product candidates. A further list and description of these risks, uncertainties and other risks can be found in Galapagos’ Securities and Exchange Commission (SEC) filings and reports, including in Galapagos’ most recent annual report on form 20-F filed with the SEC and subsequent filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
1 Helliwell PS, et al. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis: Subgroup analyses from a randomized, placebo-controlled, Phase 2 trial (EQUATOR) Abstract at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
2 Gladman DD, et al. Long-term efficacy of the oral selective Janus kinase 1 inhibitor filgotinib in psoriatic arthritis: Week 52 response patterns in individual patients from an open-label extension (OLE) study (EQUATOR2). Abstract at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
3 Gladman D, et al. Filgotinib treatment leads to rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe psoriatic arthritis. Abstract at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
4 Gilead & Galapagos Filgotinib Clinical Program Trial Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3 (NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839)
Shares of Moderna (NASDAQ:MRNA) climbed 20% in a single trading session (May 18), after the biotech company announced encouraging interim results from an ongoing phase 1 trial of its vaccine for COVID-19, the illness caused by the novel coronavirus.
Now the company is beginning a phase 2 trial to further investigate safety, immune response, and any potential adverse effects.
A researcher injects a trial participant with vaccine.
IMAGE SOURCE: GETTY IMAGES.
Two key elements I'll be looking for in upcoming reports are the performance of the vaccine in older participants, and information on the production and duration of neutralizing antibodies in participants. And I'd like to see all of this in a larger study group.
Let's take a closer look.
Moderna's phase 1 trial was designed to study its messenger-RNA vaccine in 45 healthy adults. Traditional vaccines introduce a weakened form of virus into the body to incite immune response. But Moderna's method is different. This vaccine uses messenger RNA to give the body's cells instructions to make proteins that would prevent illness.
Neutralizing antibodies
Across all participants age 18 to 55 in two dosage groups, levels of binding antibodies were at or above levels seen in people who have recovered from the virus. Binding antibodies attach themselves to the pathogen, but they don't stop infection. Information on neutralizing antibodies -- those that block infection -- was only available for eight people. In those participants, neutralizing antibodies were also at or above levels seen in recovered coronavirus patients.
The neutralizing antibody data is positive, but it's important to see that result in hundreds and eventually thousands of participants. Moderna's phase 2 trial plans to enroll 600 volunteers. I would like to see if there's a trend in neutralizing antibody production across the rest of the phase 1 participants, and participants in this second larger study.
There also is the question of how long neutralizing antibodies will remain in the body. Recovered COVID-19 patients may be a guide. At the moment, the immunity status of those who once had the illness still is unknown. "There is not enough evidence about the effectiveness of antibody-mediated immunity" to consider former patients risk-free, The World Health Organization wrote in an April brief.
A study published in the journal Immunity last month showed that while most newly discharged COVID-19 patients produced virus-specific antibodies and T-cells, their responses weren't uniform. For instance, some produced high concentrations of neutralizing antibodies, and others didn't. As for Moderna's vaccine, we'll have to wait a while to determine the duration of neutralizing antibodies in the bodies of volunteers. But it is something to monitor through the later stages of trials.
Data concerning older patients
So far, Moderna has only reported data for patients age 18 to 55. As trials move forward, I'll also be closely watching data on older patients. Moderna is enrolling two groups for the phase 2 study: ages 18 to 55, and age 55 and older. The participants will receive placebo or one of two vaccine dosages during two vaccinations 28 days apart. They will be monitored for 12 months following the second dose.
Safety and immune response in older patients are particularly important, since the elderly have been among those most at risk during this pandemic. COVID-19 is fatal for about 13.4% of patients age 80 or older, according to a study published in The Lancet Infectious Diseases. That's compared to 1.25% for patients age 50 to 59. And people 80 and older are also more likely to be hospitalized, the study showed -- 18.4% of that group, compared with 8.16% of people in their 50s.
Moderna plans to initiate a phase 3 study in July. The company hasn't said how many participants will be involved, but we can hope the number will be in the thousands. Strong data across large study groups may be the only way to assuage fears that some people have about the rapid development of a coronavirus vaccine. A recent poll by the Associated Press-NORC Center for Public Affairs Research showed only half of Americans would get the coronavirus vaccine if one is approved -- and possible side effects were the top fear.
So should we be optimistic about this biotech company's vaccine candidate at this point? Sure -- but I'd rather say "cautiously optimistic." Once data on neutralizing antibodies and vaccine performance in older adults is available -- and in a large study group -- it will be easier to bet on whether Moderna will win this coronavirus vaccine race.
What a blood bath!!!!!! Wow you nailed it. Thumb down emoji
Airlines have been hit hard by the COVID-19 pandemic, which has caused travel demand to all but evaporate. The number of travelers heading through U.S. airport security checkpoints on May 31 was down 86% year over year, and that is an improvement over the 95%-plus drop recorded in mid-April.
Airline shares fell with the passenger counts, as investors began to fear bankruptcies were inevitable. Warren Buffett's outlook for the industry was so grim that he decided to sell large stakes in the four biggest airlines at a loss. If Buffett gave up on industry stalwarts like Southwest Airlines, it's no wonder investors all but gave up on smaller, second-tier carriers like Spirit Airlines (NYSE:SAVE).
Two months into the pandemic in the U.S. and Spirit, a so-called "ultra-low-cost" carrier that at times seems best known as the butt of late-night comedian jokes, is still far from out of the woods. But if the company can survive, the stock is one of the most attractive in the industry over the next 12 to 18 months. Here are the risks, and opportunities, before Spirit investors today.
Fasten your seatbelts
Spirit expects revenue to be down 95% year over year in the current quarter and sliced in half for the full year. Obviously, that is not sustainable indefinitely, but the airline does have a cash cushion to weather the storm.
The airline had about $915 million in cash as of April 30, including initial payroll support funding provided as part of the CARES Act government stimulus plan. As of early May Spirit was burning through about $4 million per day, but that figure has hopefully come down some in recent weeks as demand appears to be slowly rebounding off an April bottom.
A Spirit A319 coming in for a landing.
IMAGE SOURCE: SPIRIT AIRLINES.
"As we think about overall liquidity, our plan is to raise enough liquidity to be able to remove the liquidity risk under almost any reasonable downside scenario and put us in a healthy position to prepare for the recovery," CFO Scott M. Haralson said on an early May investor call. "Also, we want to be able to do it in a manner that maintains the health of our balance sheet and restores our ability to grow again, once demand returns."
Assuming it does need more cash, Spirit has some options. The airline has applied for U.S. Treasury loans under the CARES Act for up to $741 million, with airlines allowed to wait until Sept. 30 to decide if they want to take all or part of what is available to them.
Spirit has $650 million in unencumbered tangible assets, including 29 aircraft. Its borrowing ability likely goes well beyond that, as the U.S. Treasury has indicated flexibility on what it takes as collateral in return for CARES Act loans. Spirit could pledge non-aircraft assets like its frequent flier program or its paid loyalty program in return for that funding, leaving planes available to be mortgaged if more capital is needed.
Spirit's business should fit the rebound
Should travel recover in the months to come, Spirit appears well-positioned to be one of the top beneficiaries. During past recessions corporate travel was the last to return, and that seems likely to be the case this time around as well with major employers halting all but essential travel and major conferences going virtual.
The first travelers who return are usually vacationers and those visiting relatives, and they tend to be the ticket buyers most easily lured back by lower fares. That's Spirit's core audience. And Spirit, thanks to its industry-low costs, can better use pricing to fill its seats than most of the industry.
In 2019, Spirit spent 7.97 cents per available seat mile, an industry metric used as a base unit for airline flying. Discount king Southwest, by comparison, spent 11.74 cents per available seat mile last year.
Of course, one of the ways Spirit achieves those ultra-low costs is by packing people onto airplanes, which might not be allowed -- or desired -- post-pandemic. Should airlines be required to fly planes half full, Spirit's cost advantage would erode somewhat, but with the entire industry forced to adapt, a cost gap should still remain.
Human behavior is hard to predict, but as someone who followed the industry in 2001 and heard pundits worry airlines would never recover, I'm skeptical that there will be permanent changes in behavior as a result of COVID-19. There will be concerns, but in the past price has been the tool to get flyers past their concerns. If history repeats, Spirit is well-positioned for this recovery.
I'm betting on Spirit
Over the next few months, Spirit management will be focused on managing two datapoints that, if monitored correctly, should allow the airline to hit cash breakeven. Either bookings will rise, or costs, and with them headcount, will fall.
In the best-case scenario, by the end of summer Spirit will be doing enough business to justify something resembling its full headcount and the added revenue will stop the cash bleed. Prior to the downturn, Spirit was among the fastest-growing airlines in the business. The growth will slow, but CEO Ted Christie said during the early May call that he still believes there will be growth:
For the next couple of years, it may be that we are smaller than we had planned before the current economic situation developed. However, we believe there are plenty of new market opportunities to support our growth, once demand begins to recover, including, perhaps, some opportunities in constrained markets that didn't exist before. In fact, we strongly believe that we will emerge from this crisis even better positioned than we were previously.
If things go wrong, Spirit is a small fringe player in the airline business and likely expendable. That's to say that if a second wave of the pandemic hits, or the economy falls into a severe depression, lawmakers and creditors are likely to ignore Spirit and focus on saving larger airlines. Given the unpredictability of the pandemic and how much is outside any company's control, there is real risk to buying into any airline right now, but smaller carriers like Spirit in particular.
But if that worst-case scenario can be avoided, and booking trends begin to improve even at modest rates, it's hard to think of an airline better-positioned cost-wise to turn things around faster than Spirit. With the stock trading at barely 0.2 times 2019 revenue, investors buying in now can hope to see the multiple expand at a much faster rate than revenue.
Shares of Spirit were down 80% since mid-February just a few weeks ago, but have rallied somewhat along with broader markets in hopes a recovery is at hand. However, the stock's still down 65% year to date. For investors who understand the risks, don't over-commit, and are interested in buying into a potential airline recovery, Spirit shares continue to look attractive at these levels.
Shares of American Airlines Group Inc. AAL, +11.18% set two new records Friday, one for volume and another for weekly gains, as an upbeat outlook for travel demand continues to fuel investor sentiment. A shockingly upbeat May jobs report also helped support the notion that the worst of the COVID-19 crisis has passed. The stock jumped 11.2% to the highest close since March 2, a day after the stock rallied aone-day record of 41.1%. Trading volume was a massive 423.6 million shares, breaking Thursday one-day record total of 399.4 million shares. The stock has run up 77.1% this week, or more than double the previous record for a weekly gain of 35.3% for the week ended March 27, 2020. Friday's rally comes even after Raymond James analyst Savanthi Syth downgraded the air carrier to underperform from market perform, saying the debt-burdened carrier's shares were "priced to perfection." The stock has still shed 35.2% year to date, while the U.S. Global Jets ETF JETS, +4.79% has slid 36.2% and the S&P 500 SPX, +2.62% has slipped 1.1%
The coronavirus outbreak has hammered the U.S. economy, with the airline sector being one of the worst-hit spaces. The virus’ spread resulted in declining air travel with restrictions imposed by the government. Consequently, airlines’ top lines suffered a material impact as passenger revenues form the largest component of their total revenue base. However, it seems like the worst is over for the airline industry as the United States has started to reopen its economy with permission for inter-state travel.
In fact, airlines in many parts of the world are planning to resume flights starting this month as economies are reopening and new safety measures are being undertaken. Going by a Bloomberg article, around 314,000 people on average went through U.S. airport security checkpoints in the week ending May 29, per the Transportation Security Administration. The metric comes at around 13% of the equivalent week a year ago and only slightly above 12% witnessed in the week ending May 22. Notably, more than 1.5 million passengers passed through airport security checkpoints during the Memorial Day weekend. Going on, American Airlines’ AAL load factor or the average share of seats filled per plane surged to 55% in the week ending May 29 in comparison to 15% in April (per a Bloomberg article).
In fact, trading session on Jun 4 saw a massive rise in airline stocks as major companies like American Airlines surged 41.3%, Delta Air Lines DAL rose 13.7% and United Airlines UAL rallied 16.2%. Also, the U.S. Global Jets ETF JETS rose 11.6% on the day. These major carriers are being observed to be adding hundreds of flights during the post-lockdown reopening of the U.S. economy. American Airlines saw a record surge following its announcement to increase schedule for flights in July by 74% in comparison with that in June.
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Current Scenario in Airlines Industry
Globally, governments have started to lift travel restrictions, thereby reviving the domestic travel industry to say the least. The travel bookings are currently being processed for business as well as pleasure trips. Per a Bloomberg article, several corporations are easing travel restrictions in states like Texas and Florida that have relaxed quarantine measures. Moreover, with summer vacations approaching, flights are being booked to Florida’s amusement parks, beaches along the Gulf Coast and mountain destinations in Montana, Utah and Colorado, according to a Bloomberg article.
However, the airlines industry is still looking for opportunities to return to more lucrative travel routes. Moreover, the international schedule can take time to normalize given the continuous spread of coronavirus. Also, some market experts believe that it will be prudent to keep a tab on whether travelers will be returning to pre-pandemic levels in the near term as they might not want to take the chances of re-emergence of the coronavirus outbreak due to travelling. Furthermore, airlines may have to face the brunt of rising oil prices on their already stressed balance sheets.
Against this backdrop, investors can keep a tab at the following airline ETF:
U.S. Global Jets ETF JETS — up 27% since start of June
The fund provides investors access to the global airline industry, including airline operators and manufacturers from all over the world. With AUM of $1.41 billion, the fund holds a basket of 39 stocks. It trades in average volumes of about 2.1 million shares a day. It also has an expense ratio of 60 basis points (read: These ETF Areas Make Great Investment Choices in June).
Just warming up my friend
#CHEF LIFE #
All good
???????? 30 Dollars EOD high???????
We HAVE Liftoff $$$$$$$$$$
Agreed my friend. Any run we get tends to b slowed down buy sellers flipping for beer money. Let em sell. I’m a long here so after Q2 hits we shall see what is our future has for us. GLTA
18 plus today???????