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BRUSSELS (Reuters) - The European Commission said on Friday it had given conditional approval for the use of antiviral remdesivir in severe COVID-19 patients following an accelerated review process, making it the region's first authorised therapy to treat the virus.
The move comes just a week after the European Medicines Agency (EMA) gave its go-ahead for the drug, produced by Gilead Sciences (O:GILD), to be used in adults and adolescents from 12 years of age who are also suffering from pneumonia and require oxygen support.
It also comes just days after the company allocated nearly all of its supply of remdesivir to the United States over the next three months, stirring concerns about availability elsewhere.
"We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus," said Stella Kyriakides, EU Commissioner for Health and Food Safety, in a statement.
The Commission said on Wednesday it was in negotiations with Gilead to obtain doses of remdesivir for the 27 European Union countries.
Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial.
It is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies like the steroid dexamethasone.
Still, because remdesivir is given intravenously over at least a five-day period it is generally being used on patients sick enough to require hospitalisation.
The EU's green light broadens the use of remdesivir around the world - the United States has cleared it for emergency use and it is also approved as a COVID-19 therapy in Japan, Taiwan, India, Singapore and the United Arab Emirates, Gilead said on Friday.
A conditional marketing authorisation is one of the EU regulatory mechanisms created to facilitate early access to medicines that fulfil an unmet medical need, including those for emergency situations in response to public health threats such as the current pandemic, the Commission said.
The approval is valid for one year in the bloc and can be extended or converted into an unconditional marketing authorisation if all necessary data are available on its efficacy and side effects.
The agency reviews data as they become available on a rolling basis, while development is still ongoing. The EMA's rolling review began at the end of April.
Shares of Waitr Holdings (NASDAQ:WTRH) briefly popped this morning, up as much as 14% in early trading before giving up those gains. The stock is down 2% as of 1:15 p.m. EDT, after the company announced it has expanded its service team.
So what
The regional food delivery tech company said it has hired 225 customer service and dispatch workers since January of this year. Those employees will be based in Louisiana, where Waitr is headquartered, instead of a previous plan to locate those positions, in addition to other jobs, in Mexico.
Eleven takeout containers holding various types of food with chopsticks resting on some of the boxes
IMAGE SOURCE: GETTY IMAGES.
"We believe it's important to support our communities during these times and are pleased to have been able to bring so many jobs back to the U.S," CEO Carl Grimstad said in a statement. "We are very proud of our team members in Louisiana, who have been providing the highest levels of service for our customers, drivers and restaurant partners."
Now what
Waitr did not detail the cost implications of keeping those jobs within the U.S., but the company noted that Grimstad has implemented various other strategic initiatives to improve profitability since becoming CEO in January. That included transitioning drivers into independent contractors, which drivers criticized since many lost benefits that hourly employees are entitled to. Most food delivery platforms use a similar independent contractor model for drivers.
Waitr added that February was the first profitable month in the company's history, due in part to these initiatives. Food delivery has been one industry that has remained resilient during the COVID-19 pandemic as people order food from the safety of their homes.
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Moderna (NASDAQ:MRNA). While Moderna's share price has more than tripled so far in 2020, Inovio stock has skyrocketed more than 700%.
But year-to-date stock performance isn't the best way to choose between two stocks. There's a strong case to be made that Moderna is actually the better pick of these two coronavirus-focused biotech stocks. Here are three reasons why -- plus one reason why Moderna is less attractive than Inovio.
Four vaccine vials labeled COVID-19 Vaccine
IMAGE SOURCE: GETTY IMAGES.
1. Moderna's COVID-19 vaccine is ahead
The most obvious reason that Moderna beats Inovio is that its COVID-19 vaccine candidate is ahead of Inovio's candidate. Moderna's mRNA-1273 is currently in a phase 2 clinical trial. The biotech expects to begin a pivotal phase 3 study in July. Inovio reported positive interim phase 1 data for INO-4800 on June 30, and hopes to start a phase 2/3 study this summer.
Granted, a head start in clinical testing doesn't necessarily mean that mRNA-1273 will ultimately be safer and more effective than INO-4800. However, if Moderna's late-stage study goes well, its lead in clinical progress could translate to greater commercial success.
Importantly, health officials recognize Moderna as a leader in the race to develop a COVID-19 vaccine in a significant way: The Trump administration selected only a handful of experimental COVID-19 vaccines to receive federal funding. Moderna's vaccine was on the list, while Inovio's wasn't. And recently, World Health Organization chief scientist Soumya Swaminathan pointed out two leaders in COVID-19 vaccine development. Again, Moderna was one of her picks, and Inovio wasn't.
2. Moderna's cash stockpile is much bigger
Neither Moderna nor Inovio is anywhere close to making a profit. This means that both biotechs are burning cash. But Moderna has a lot more to burn than Inovio does.
As of March 31, Moderna's cash stockpile stood at $1.7 billion, including cash, cash equivalents, and investments. The company also has up to $700 million in potential grants and awards. Last month, Moderna boosted its cash position even more, raising around $1.34 billion in gross proceeds from a stock offering.
Inovio's cash, cash equivalents, and short-term investments totaled $270 million as of March 31. Since then, the company sold shares to raise net proceeds of close to $122 million.
Funding clinical studies requires a lot of money. Launching a new product will require a lot of money. Inovio is more likely than Moderna to need to conduct another stock offering to raise cash, so Inovio is also more likely to dilute the value of its existing shares sooner than Moderna.
3. Moderna's track record isn't as questionable
Inovio's pipeline might seem more impressive than Moderna's. Both biotechs have 15 candidates in clinical testing. However, Inovio has one late-stage candidate (VGX-3100), while Moderna has none. Nine of Inovio's programs are in phase 2, compared to only three for Moderna.
It's important to consider, though, that Inovio was founded in 1983 and still has no products on the market. That's 37 years and counting with no clinical success that ultimately mattered.
What about Moderna? It was founded relatively recently, in 2010. The company's messenger RNA technology excited investors so much that Moderna's initial public offering in 2018 was the biggest biotech IPO ever.
The bottom line is that Moderna's track record simply isn't as questionable as Inovio's. In one decade, Moderna has built a pipeline with as many clinical programs as Inovio has in nearly four decades.
American Airlines
American Airlines is gearing up for summer by restoring 55 percent of its domestic schedule and almost 20 percent of its international schedule in July 2020, as compared with last year. According to a statement, American will increase flights to hubs Dallas Fort Worth International Airport and Charlotte Douglas International Airport, as well as destinations including Asheville, N.C., Savannah, Ga. and Charleston, S.C.
In July, American will also "offer more seats to Florida than any other airline" and increased service to Montana, Colorado, Utah and Wyoming as national parks reopen once again.
The airline announced on Friday that it will no longer be capping the number of seats sold on flights amid the COVID-19 pandemic.
The coronavirus has had a devastating effect on a plethora of industries, with cruise operators amongst the most badly hit.
The recent spike in coronavirus cases has sown further uncertainty. Timelines for the resumption of sailings have been pushed back further into the unknown, raising even more concern regarding the industry’s future.
Yet, this is precisely why Tigress Financial analyst Ivan Feinseth believes the time is right to consider an investment in the world’s largest cruise operator Carnival (CCL).
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The 5-star analyst reiterated a Buy rating on CCL “as it will overcome COVID-19 pandemic headwinds, and the pullback in the stock creates a long-term buying opportunity.” However, Feinseth has no fixed price target in mind. (To watch Feinseth’s track record, click here)
Once cruise lines are unleashed on the waves again, Feinseth predicts the industry will bounce back with a vengeance. Driving his long-term thesis for Carnival, in particular, are three main points.
For one, despite the uncertainty, future booking trends are holding up well. “CCL is experiencing pricing trends for 2021 within the historical ranges of 2019,” Feinseth noted. He also highlighted the fact that 55% of customers booked on cancelled cruises are rebooking or accepting a “future cruise credit over cash refunds.” Even those requesting their money back, Feinseth says, have indicated an intention to rebook once normality resumes.
Secondly, further supporting the analyst’s confidence is the cruise operator’s focus on stringent health protocols to ensure passengers’ safety. “When sailings resume, cruise ships will have a more controlled environment, offering increasing safety from potential pandemics as CCL implements fleetwide programs incorporating state-of-the-art safety protocols,” the analyst reassured.
Lastly, until it is able to resume operations, Carnival has taken the required steps to maintain the health of its balance sheet. Feinseth noted, “CCL has undergone extensive capital conservation initiatives, including significantly reducing operating expenses as well as reducing and, where possible eliminating discretionary capital expenditures.”
These “debt and equity offerings” should keep CCL well-funded until at least early 2021, which is when Feinseth expects sailing, at the latest, to resume.
So that’s Tigress Financial’s view, what about the rest of the Street’s take? Overall, Feinseth’s fellow analysts aren’t quite as bullish. 4 Buy ratings, 12 Holds and 4 Sells add up to a Hold consensus rating. The average price target clocks in at $16.91, and implies possible upside of 10%. (See Carnival stock-price forecast on TipRanks)
Moderna, Inc. (MRNA)
Last but not least, we come across Moderna, which has grabbed headlines left and right as a result of its experimental COVID-19 vaccine, mRNA-1273.
Representing Piper Sandler, 5-star analyst Edward Tenthoff has high hopes based on early data. After MRNA published a preprint of mRNA-1273 preclinical data while simultaneously under peer-review for publishing in a leading medical journal, the analyst tells investors that the data suggests “mRNA-1273 supports clinical activity in humans.”
“mRNA-1273 formulated in lipid nanoparticles elicited a balance both humoral (antibody) and cellular (CD8 T cell) immunity. Mice immunized with 0.0025-20mcg of mRNA-1273 demonstrated strong dose-dependent correlation between binding and neutralizing antibody responses. Importantly, mice receiving two 1.0mcg doses of mRNA-1273 were completely protected from viral replication in lungs and nasal cavities after re-challenge at 5- and 13-weeks following boost,” Tenthoff explained.
Looking more closely at the candidate, it targets a pre-fusion Spike protein stabilized by two proline substitutions. This is important as it could allow for a more generalizable approach to be used to protect against mutations.
It should also be noted that the Phase 2 study of mRNA-1273 has already enrolled 300 healthy adults aged 18-55 years, and 50 out of 300 subjects over the age of 55. According to Tenthoff, the data from this study should “further validate safety and efficacy of the 100µg dose in a broader population, which was selected for the Phase 3 trial.” This trial is set to kick off in July.
Tenthoff added, “Lonza will support manufacturing of 500 million-1 billion doses per year. mRNA-1273 holds Fast Track Designation.”
Based on all of the above, it’s no wonder Tenthoff reiterated his Overweight rating. With a $100 price target, shares could gain 61% in the next twelve months. (To watch Tenthoff’s track record, click here)
Looking at the consensus breakdown, other analysts are on the same page. With 11 Buys and 2 Holds, the word on the Street is that MRNA is a Strong Buy. The $87.64 average price target puts the upside potential at 42%. (See Moderna stock-price forecast on TipRanks)
Gilead Sciences, Inc. GILD announced pricing for experimental coronavirus drug, remdesivir.
The company set a price for governments of developed countries at $390 per vial which equates to $2,340 per patient as the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir.
In the United States, the same government price of $390 per vial will apply. However, due to the way the U.S. system is set up and the discounts expected by government healthcare programs, the price for private insurance companies will be $520 per vial in the country.
Gilead has entered into an agreement with the U.S. Department of Health and Human Services (HHS), whereby HHS and states will continue to manage allocation to hospitals until the end of September.
For the developing countries, Gilead has entered into agreements with generic manufacturers to deliver treatment at a substantially lower cost.
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The company expects its investment in the development and manufacture of remdesivir to exceed $1 billion by the end of 2020.
The pricing was lower than most estimates.
Gilead’s shares have rallied 19.4% in the year so far compared with the industry’s growth of 10.4%. In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.
On the daily chart above, it clearly shows American Airlines stock rallying up to the 200-day moving average, before being rejected from this clear level of resistance.
Since then, it has put in a series of lower highs, as downtrend resistance (blue line) squeezes the share price lower. Now though, down 46% from the June highs, bulls may have a solid risk-reward opportunity.
Specifically, American Airlines stock has corrected down to the 50-day moving average. Further, the $12.50 area was one of resistance for several months. Seeing this level act as support alongside a key moving average and amid such a swift decline would be bullish.
The reason the trade seems attractive though is the limited risk. A close below $12 is enough reason for bulls to cut their losses, as it becomes clear that support in theory is not support in practice.
If support holds, look for a move up through the 23.6% retracement, at $13.57. Above that puts downtrend resistance in play, followed by a possible test of the 20-day moving average currently near $15.40.
American Airlines stock may very well fail to put together a decent bounce, but the risk/reward is there for aggressive traders
Source: Jarretera / Shutterstock.com
Many traders would say that ACB is marijuana-stock royalty. It’s one of the world’s biggest cannabis companies and should be able to weather the Covid-19 storm better than Aurora’s smaller competitors. Plus, the company recently earned nods of approval from a pair of prominent analysts.
The first comes from Cantor Fitzgerald analyst Pablo Zuanic. He increased his price target on ACB stock from 27 CAD to 29 CAD. Zuanic also reiterated his “overweight” rating on the shares, citing Aurora’s cost-cutting measures. For instance, the company announced 25% reduction in Aurora’s corporate staff over a six-month period.
Also, analysts at Stifel upgraded ACB stock from “sell” to “hold” recently. Noting Aurora’s “market share gains” and the “stronger Canadian market trends,” Stifel analysts raised their price target on the stock from 6.20 CAD to 17.50 CAD. With these upgrades in mind, Aurora’s shareholders should remain confident in a stock-price rebound in the near future.
The world’s biggest cruise line operator, Carnival, doubles as one of the best cruise stocks to buy now.
By my numbers, CCL stock could rally 70%+ over the next 18 months.
Of course, fiscal 2020 for this company will be awful. For more than half of the year, the company will run zero cruises. For the other half of the year, cruise capacity will be significantly depressed — if those planned cruises run at all.
Fiscal 2021 will be a much better year. Consumers will get more comfortable with riding on cruises, especially if prices remain discounted and if a vaccine is approved by early 2021. Concurrent to that, Carnival will increase cruise capacity. The company’s revenues and profit margins will meaningfully rebound.
By fiscal 2022, things should be largely back to “normal” for Carnival. The virus will be more than two years old. The vaccine will have been in circulation for more than a year. Global travel trends will start to look like they did in 2019.
Assuming so, Carnival’s fiscal 2022 revenues should be awfully close to where they were in fiscal 2019 (approximately $21 billion). Profit margins won’t rebound to where they had been historically — roughly 17% average operating margin from 2015 to 2019 — but should recover to a lower steady-state around 10% to 12% thanks to higher cleaning and maintenance costs.
Under those assumptions, $2.40 seems like a doable earnings per share target for Carnival by 2022. CCL stock historically trades at 13-times forward earnings.
That combination implies a fair 2021 price target for CCL stock of over $31 — or more than 70% above where shares trade today. All of that together makes Carnival one of the best cruise stocks to consider buying now.
It’s sad that is for sure. Going to have to write my losses off on this one
After announcing this morning that it is ending its fight to stay listed on Nasdaq, China-based coffee chain and delivery company Luckin Coffee announced that it is requiring that its chairman, Lu Zhengyao, resign in a filing with the SEC.
Luckin Coffee will unluckin’ly delist from Nasdaq following fraud allegations
It also announced in its SEC filing that the chairman has requested the firing of independent director Sean Shao through a shareholders resolution, which will be voted upon at a shareholders meeting to be held on Sunday, July 5th.
My god.
It’s getting ugly at Luckin, which is struggling to turnaround in the aftermath of revelations of a $300 million accounting fraud that has seen its stock price plummet in recent months. Shao has been leading the board’s independent investigation over the accounting irregularity.
Luckin Coffee’s board initiates investigation into $300M potential fraud
Now, at a shareholders meeting, the board will be up for grabs, with investors in the company (yes, there are still investors!) choosing who to keep and who to fire in a devolving case of corporate governance run amok.
In addition to voting on several current directors of the company, shareholders will also vote on installing two new independent directors, Zeng Ying and Yang Jie, who have long-time business and legal backgrounds.
We had previously known about the extraordinary shareholders meeting, but now the company has upped the ante, by voting to force out the chairman by July 2 — three days before the shareholders meeting is scheduled to take place.
Honestly, at this point, it’s impossible to say what comes next. But what I can say is that Luckin is currently trading down 54% at close this Friday, and is worth barely a few hundred million dollars — down from its peak market cap of over $12 billion. Wh ever wins is going to own some truly empty cups.
Shares of American Airlines Group Inc. swung to a gain at Thursday’s close, erasing a sharp loss early in the session to snap a long losing streak, as continued improvement in travel demand helped fend off, for the moment, concerns over a recent surge in new COVID-19 cases.
American Airlines’ stock AAL, +0.99% closed up 1.0% at $13.17, erasing a loss of as much as 6.6% at its intraday low. The gain snapped a six-session losing streak, the longest since the six-day stretch ended April 2, in which the stock had tumbled 23.4%.
The stock’s late rally into positive territory comes after the air carrier announced a $4.5 billion boost to liquidity this week, including a $2.5 billion notes offering that priced late Wednesday and $2 billion worth of common stock and convertible debt offerings that priced on Tuesday.
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The offering of $2.5 billion senior secured notes due 2025, which was upsized from $1.5 billion, priced slightly below par — 99% of face value — despite paying an interest rate of 11.75% per annum. That compares with the yield on 5-year Treasury notes TMUBMUSD05Y, 0.313% of 0.32%.
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While the increased cash balances following the offerings “removes liquidity risk,” UBS analyst Myles Walton American’s “problem” isn’t the amount of cash it has, but how much cash it burns to operate. And with cash burn set to continue, “the return to normalized earnings is so far out that material downside remains for the equity,” Walton wrote in a note to clients.
He reiterated the sell rating he’s had on the stock since late 2019, but trimmed his price target to $9, which is 28.5% below current levels, from $10.
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American’s stock became part of a broader airline sector rally, as the U.S. Global Jets exchange-traded fund JETS, +1.53% climbed 1.5% to bounce of Wednesday’s three-week closing low. The Jets ETF, which dropped 5.9% on Wednesday to suffer a fifth loss in six days, has lost 24.4% since closing at a three month high of $21.94 on June 8.
Among the sector tracker’s other more-active components, shares of United Airlines Holdings Inc. UAL, +4.89% ran up 4.9%, Delta Air Lines Inc. DAL, +2.45% climbed 2.5%, Spirit Airlines Inc. SAVE, +2.83% hiked up 2.8%, Southwest Airlines Co. LUV, +2.23% advanced 2.2% and JetBlue Airways Corp. JBLU, +4.04% rallied 4.1%.
The Dow Jones Transportation Average DJT, +1.13% , which includes six airline components, rose 1.%, while the Dow Jones Industrial Average DJIA, +1.17% jumped 299.66 points, or 1.2%.
Helping fuel the rally, data from the Transportation Security Administration (TSA) shows that the number of people going through traveler checkpoints continues to increase.
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The average daily number of travelers for the week ended Sunday has increased for nine straight weeks, to reach 522,327 in the latest week, up from a trough of 97,799 for the week ended April 19, according to a MarketWatch analysis of TSA data. Meanwhile, the decline from a year ago in average daily passengers per week has decreased each week, to 80.0% in the latest week from a peak of 95.8%, also for the week ended April 19.
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More ominously, however, the number of new cases of the coronavirus illness in the U.S. rose to 34,700 on Wednesday, the highest level since the peak of 36,400 seen in late April, according to the Associated Press, with data aggregated by Johns Hopkins University of Medicine indicating 30 states are seeing increased infection rates over the past week.
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With a market value of more than $14 billion, Carnival is a global cruise company that operates voyages to around 700 ports under brands such as Carnival Cruise Lines, Holland America, and Princess Cruises. The Miami-based leisure travel company, which reported a $4.4 billion second quarter loss due to pandemic cancellations, has vowed to step up its ship-cleaning procedures when it resumes operations. Although Carnival stock has shed 63.6% on the year, it has recovered 50% in the past three months as of June 24, 2020. The company suspended its dividend and share buyback program in March to preserve liquidity.
The cruise line operator's share price broke above a three-month ascending triangle in early June on increasing volume. More recently, the stock has retraced to the pattern's top trendline that now provides a crucial support level. Those who buy here should look for a test of $30, where the shares may encounter resistance from a late February countertrend bounce and the downward sloping 200-day simple moving average (SMA). Protect downside by placing a stop under either the June 22 low or beneath the 50-day SMA, depending on risk tolerance.
Stifel analysts upgraded the stock of Aurora Cannabis Inc. ACB, 4.20% WEED, -0.47% to hold from sell on Wednesday, and said an update on the business offered on Tuesday suggested it has "weathered the storm." Analysts led by W. Andrew Carter raised their stock price target to C$17.50 ($12.89) from C$6.20. "We believe ongoing cash needs, potential equity dilution, and risk around debt covenants remain as impediments to a more constructive approach with the shares enjoying a still robust valuation (C$2.5 billion enterprise value)," the analysts wrote. "But with the reiteration of the F1Q21 positive EBITDA target, market share gains by Aurora,and stronger Canadian market trends, we believe the fundamental outlook and potential for capitalizing on the global cannabis category's development are back in focus." Aurora announced further cost cuts, including job cuts, on Tuesday and reiterated that it expects to have positive adjusted EIBTDA in the first quarter of fiscal 2021. Cantor Fitzgerald reiterated its overweight rating on the stock late Tuesday. Shares were slightly higher premarket, but are down 48% in the year to date. The Cannabis ETF THCX, -2.17% has fallen 19% in the same time frame, while the S&P 500 SPX, -1.74% has fallen 3%.
(Reuters) - Gilead Sciences Inc said on Tuesday it would buy a 49.9% stake in privately held cancer immunotherapies developer Pionyr Immunotherapeutics Inc for $275 million.
The drugmaker said it has also secured the right to acquire the rest of Pionyr for a $315 million option exercise fee.
Pionyr's immuno-oncology product candidates, PY314 and PY159, have shown potential against solid tumors in animal studies and it plans to file applications with the U.S. Food and Drug Administration in the third quarter to begin human testing.
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Gilead has been expanding its oncology portfolio. In March, the company announced a $4.9 billion deal for Forty Seven Inc, adding an experimental treatment that targets blood cancer.
The deal comes as Gilead is racing to expand the global supply of its antiviral drug remdesivir for use in COVID-19, a respiratory illness that has no currently approved treatments or vaccines.
Pionyr's shareholders are also eligible to receive up to an additional $1.47 billion in option exercise fees and future milestone payments.
Gilead Sciences Inc. (GILD) said it expects to produce more than 2 million treatment courses of its experimental coronavirus drug candidate remdesivir by the end of the year and many millions more in 2021.
After getting the green light from the U.S. Food and Drug Administration (FDA), Gilead announced that it is planning to start Phase 1 trials of an inhaled version of remdesivir this week and begin studies in patients with COVID-19 in August.
Remdesivir is an investigational antiviral virus candidate, which is currently given to patients intravenously through daily infusions in the hospital. An inhaled formulation would be given through a nebulizer, which Gilead said could potentially allow for easier use outside the hospital, at earlier stages of the disease.
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“That could have significant implications in helping to stem the tide of the pandemic,” Gilead CEO Daniel O'Day said in an open letter.
O’Day added that the company is also exploring whether patient outcomes can be improved by combining remdesivir with other therapies to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response.
In addition, Gilead announced plans for a “next wave of studies” of remdesivir, which will include vulnerable patient populations, including a study in pregnant women.
Remdesivir is a viral RNA polymerase inhibitor which means that it interferes with the production of viral genetic material, preventing the virus from multiplying. Gilead’s investigational antiviral therapy has received Emergency Use Authorization (EUA) by the FDA to treat COVID-19.
Shares in Gilead declined 1.6% to $76.23 in midday U.S. trading trimming the year-to-date advance to about 17%.
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- American Airlines Group Inc (O:AAL) said on Sunday it plans to secure $3.5 billion in new financing, to improve the airline's liquidity as it grapples with travel restrictions caused by the coronavirus.
The company plans to raise $1.5 billion by selling shares and convertible senior notes due 2025, the airline said in a statement.
Additionally, the airline said it will offer $1.5 billion in senior secured notes and that it intends to enter into a new $500 million term loan facility due 2024.
The company expects to use the net proceeds from the stock and convertible notes offerings for general corporate purposes and to enhance its liquidity position, the airline added.
The stock and convertible notes offerings, first reported by Bloomberg News, include a 30-day option for the underwriters to purchase up to $112.5 million of additional common shares and up to $112.5 million of additional convertible notes respectively, the company said.
Goldman Sachs (NYSE:GS) & Co. LLC, Citigroup (NYSE:C), BofA Securities and JP Morgan will be acting as representatives for the underwriters.
Interesting find here. What’s all the chatter???
I’m good with that$$$$$$$
June 21 (Reuters) - India's drug regulator has given Hetero Labs the green light to manufacture and market its generic version of Gilead Science's experimental COVID-19 treatment remdesivir, the Indian pharmaceutical company said on Sunday.
The drug, which will be marketed under the brand name Covifor, will likely be priced at 5,000 to 6,000 rupees ($66-$79) for a 100 milligram dose, Hetero said.
India's Cipla Ltd has also received approval from the Drug Controller General of India (DGCI) to manufacture and market the drug, according to a report https://bit.ly/2AVcs0y in Indian Express.
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Moments TMP
Cipla and DGCI were not immediately available for comment.
Gilead Sciences Inc signed non-exclusive licensing pacts last month with five generic drugmakers based in India and Pakistan to expand the supply of its COVID-19 treatment.
The pacts allow Jubilant Life Sciences Ltd, Cipla, Hetero Labs, Mylan NV and Ferozsons Laboratories Ltd to make and sell the drug in 127 countries. (Reporting by Sabahatjahan Contractor in Bengaluru; Editing by David Clarke)
For years now, Aurora Cannabis (ACB) and Canopy Growth (CGC) have traded in near lockstep based on the global growth potential of cannabis. The latest quarterly results set Aurora Cannabis a step ahead of their prime competitor in Canada.
Aurora Cannabis reported an exceptional turnaround quarter for March, but the stock has taken a hit following the weak Canopy Growth results at the end of May. Oddly, Aurora Cannabis now appears better positioned to thrive having already had to tighten their financial purse strings due to cash concerns.
Value Brand Shift
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Moments TMP
Canopy Growth called out a prime reason for their failure to hit revenue targets in the March quarter due to the market shift to value brands. Aurora Cannabis made this move to shift production towards the value brand Daily Special in early Q1.
For this reason, Aurora Cannabis saw recreational cannabis sales grow sequentially by C$8 million to C$42 million. Canopy Growth saw recreational cannabis slip by C$20 million to C$49 million. Canopy Growth was too busy focused on the struggling cannabis beverages startup and missed the recreational cannabis shift to more affordable products to compete against illegal weed.
Aurora Cannabis has already shown an ability to shift quicker than Canopy Growth. The latter is still going through a complete leadership change with executives from the liquor sector possibly not as familiar with cannabis.
Focus, Focus, Focus
One of my biggest complaints about the Canadian cannabis LPs was the focus on global operations. The companies were going after massive markets in Canada, the U.S. and in Europe, Latin America, Australia and even Africa. The vast operations made little sense for companies trying to build new markets. Building market share in recreational cannabis in Canada and CBD in the U.S. was more than complicated enough for executive leaders to not need further operations in Germany, Columbia or Australia.
Aurora Cannabis made the decision in February to reduce operating costs by over 50% to below C$45 million per quarter. The company shifted out of most international locations with a focused shifted to Canada, U.S. and Germany.
The Canadian company has a singular focus on profitable growth now while Canopy Growth still appears to be investing in money losing businesses for a payoff in out years. Aurora Cannabis now has the upper hand here with a path to EBITDA profits in the September quarter while Canopy Growth pulled guidance for the rest of the year while generating substantial EBITDA losses in the March quarter.
C$27 Price Target
What would you tell someone if they were to ask you, “Should I buy Aurora Cannabis stock right now?” For Cantor analyst Pablo Zuanic the answer is quite clear — the analyst sees the stock as a plant that keeps blossoming.
"ACB is a company with a credible turnaround plan, not going bust, and with little further dilution risk. ACB is a close #2 in Canada rec to Canopy Growth; it is #1 in Canada med with share north of 40%; and it has reconfigured its international business, but its opportunities are not less than those of peers," Zuanic noted.
Wieser rates ACB a Buy along with a C$27 price target, which implies nearly 50% upside from current levels.
Takeaway
The key investor takeaway is that the valuation equation for Aurora Cannabis is far more compelling here as the market has pushed the stock back down below $14. The stock has a far better valuation at $1.5 billion with FY21 sales estimates near $300 million while Canopy Growth trades at $6.3 billion with sales estimates near $400 million.
Aurora Cannabis is a far better deal, if an investor can purchase the stock closer to my $10 target. Regardless, the company has leap frogged Canopy Growth as the better investment due
As Moderna prepares to launch a Phase 3 trial of its Covid-19 vaccine in July, the company’s CEO says there’s a high probability that the company’s product could reach distribution in 2021.
“It seems to be possible that we could have efficacy data by, let’s say, Thanksgiving,” Moderna (ticker: MRNA) CEO Stéphane Bancel said during Barron’s Investing in Tech conference Wednesday. That data would potentially allow Moderna to fight for approval either late this year or early in the new year, Bancel said.
The company recently announced it hopes to recruit 30,000 people for its Phase 3 trial—”a lot of people, indeed,” the CEO said. “We are very, very interested in knowing as much as we can about this vaccine and to ensure it is safe,” he said. The Food and Drug Administration has the same objective, emphasizing that the large pool of volunteers has been discussed and agreed upon with the agency.
On the Front Line of Developing a Covid-19 Vaccine
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A large cohort of trial participants is also essential for geographic reasons. “We do not know where exactly outbreaks will happen in the fall,” Bancel said. With volunteers receiving either the active vaccine or a placebo at sites across the country, “wherever outbreaks happen, we’ll be able to see cases,” he said.
As Barron’s previously reported, Moderna is one of several companies using relatively new technology to create a Covid-19 vaccine. FDA approval of the technology, which uses synthetic messenger ribonucleic acid, or RNA, to create a protein that provokes an immune response, could pave the way for the rest of the company’s pipeline.
Bancel said the company’s experience creating vaccines is partially responsible for the speed of Moderna’s Covid-19 vaccine candidate. “This was actually the 10th vaccine that we put in clinical trial,” Bancel said. “We’ve learned a lot over the years: how to optimize the manufacturing process, how to optimize your chemistry, to get the best vaccine we could.”
With the vaccine’s clinical and manufacturing plans addressed, Moderna is now working with several groups to determine the vaccine’s economic value and how much of a share of that value the company thinks is fair to capture, Bancel said. “We need to make sure that the vaccine is affordable so that everybody can be vaccinated, either because it’s paid by a private payer or by the government.”
While Moderna is far from the only company working to produce a Covid-19 vaccine—as of mid-May, there were more than 100 vaccine programs under way—Bancel said he doesn’t see other companies’ vaccine efforts as a negative. “There is no one company in the world who has a manufacturing capacity to supply the planet,” he said, adding his belief that many vaccines will eventually be approved. “And we need those because we have to vaccinate a lot of people to stop this public health emergency.”
Gilead Sciences Inc. GILD, -1.15% said Wednesday it started a clinical trial of using its drug remdesivir to treat COVID-19 in pediatric patients. "While the novel coronavirus appears to disproportionally affect adults - especially the elderly and those with underlying health conditions - concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms," said Gilead Chief Medical Officer Merdad Parsey in a statement. The drug maker said it will begin enrolling about 50 pediatric patients for the study ranging from newborns to adolescents. On May 1, the Food and Drug Administration granted an emergency use authorization for remdesivir to treat COVID-19, and said this week that treatments recently touted by President Donald Trump could interfere with the drug's effectiveness.
JERUSALEM (Reuters) - Israel has signed an agreement with Moderna Inc for the future purchase of its potential COVID-19 vaccine, Prime Minister Benjamin Netanyahu said on Wednesday.
The Cambridge, Massachusetts-based biotech firm last week confirmed plans to start a trial of 30,000 volunteers of its much-anticipated vaccine in July as the company enters the final stages of testing.
It is one of several vaccines being tested around the world as drugmakers race to combat the pandemic. There are currently no approved treatments or vaccines for COVID-19.
"Israel has signed with the company Moderna an arrangement that will allow us to buy vaccines," Netanyahu said, according to a statement from his office.
"The company is advancing its development, they claim they can achieve it by the middle of next year, we hope that they succeed," he said.
Financial details were not disclosed.
Netanyahu added that Israel would continue its own efforts to develop a COVID-19 vaccine through the Israel Institute for Biological Research.
Israel - with a population of 9 million - has reported 19,783 novel coronavirus cases and 303 deaths. It has seen a spike in new infections since reopening schools, restaurants and many businesses last month.
Other countries, including France, Germany and Italy, have signed supply deals with British drugmaker AstraZeneca for its potential COVID-19 vaccine.
(Reporting by Ari Rabinovitch and Tova Cohen, Editing by Rami Ayyub and Emelia Sithole-Matarise)
Investment banker J.P. Morgan predicted "a reasonable, albeit slow, recovery in operations" for cruise lines Carnival Corporation (NYSE:CCL) (NYSE:CUK), Norwegian Cruise Line Holdings (NASDAQ:NCLH), and Royal Caribbean (NYSE:RCL) last week, but said shares would "remain choppy and range-bound until investors receive more clarity" on such data points as, well, precisely when the CDC will permit cruise lines to resume cruising.
And they were half right -- maybe more than half.
Today, on a no-news day for the cruise industry, shares of Carnival, Norwegian Cruise, and Royal Caribbean stock are busting out all over, each up more than 10% in early trading. By 10:45 a.m., each cruise line stock had given up some of its gains, but Carnival is still hanging onto a 7% profit for the day, Norwegian's up 7.5%, and Royal Caribbean, 5%.
Cruise ship at sea
IMAGE SOURCE: GETTY IMAGES.
So what
What exactly is going on here? Let me first eliminate the obvious suspects:
There have been no analyst upgrades, nor price target changes, from Wall Street's analysts on any of these three stocks today. Nor have Carnival, Norwegian, or Royal Caribbean issued any updates on their operations. The CDC has given no more clarity on when cruisers can resume cruising: We're still looking at a July 24 date for earliest resumption of operations, unless the CDC extends its no-sail order again.
What news we do have is more macro in nature. In England, clinical researchers are having some success treating COVID-19 patients with low doses of a common steroid injection known as dexamethasone to reduce inflammation that can interfere with breathing. They're finding that the steroid improves survival rates of patients on ventilators or taking supplemental oxygen, but doesn't otherwise improve outcomes for patients with less severe symptoms of COVID-19.
Still, any treatment is better than no treatment, and this news from the UK is a positive for consumer-facing businesses such as the cruise lines.
Meanwhile, in other news, Marketwatch reports today that President Donald Trump is pushing a $1 trillion infrastructure spending plan to stimulate the economy. On the one hand, that should have no direct effect on the cruise industry whatsoever. On the other hand, though, pushing more money into the economy means some of that money will eventually trickle into the pockets of discretionary consumers who might spend it on pleasure cruises.
Now what
Long story short, I see no particular reason to get excited about cruise stocks today. This is still a heavily indebted industry ($7.5 billion in net debt at Norwegian at last report, $13 billion at Royal Caribbean, and $13.1 billion at Carnival).
It's an industry that was once pretty profitable, but one that is losing money today. It's an industry certain to keep on losing money for as long as the CDC keeps cruise ships locked in port, and one probably destined to lose money for some time thereafter, as cruise lines struggle first to convince tourists that it's safe to board their boats, and then must find a way to survive on 50% or less occupancy rates in order to promote social distancing for a while.
Shares of Moderna (NASDAQ:MRNA) fell 3.4% on Tuesday, as the race for a COVID-19 vaccine intensifies.
So what
Several vaccine development projects that are employing similar technology as Moderna have recently received substantial funding. This includes projects led by German biotech CureVac -- which received a $337 million investment from the German government on Monday -- and Imperial College London, which received more than $50 million from the UK government.
A person in a hazmat suit holding a liquid-filled tube.
MODERNA STOCK FELL ON TUESDAY. WILL IT THE BE FIRST TO DEVELOP A COVID-19 VACCINE? IMAGE SOURCE: GETTY IMAGES.
In all, more than 100 vaccines are currently being developed around the world. Moderna has some formidable rivals, including healthcare titans Johnson & Johnson, Pfizer, and AstraZeneca.
Now what
Moderna CEO Stephane Bancel told Bloomberg that its efficacy data for its coronavirus vaccine candidate, mRNA-1273, could be available by Thanksgiving in a best-case scenario. Moderna is currently conducting a Phase 2 study of its experimental COVID-19 vaccine, and it plans to begin a Phase 3 study in July.
With infection counts rising, governments across the world are scrambling to secure potential coronavirus vaccines and treatments. Moderna recently reached an agreement with Israel for the future purchase of its vaccine, should it prove both safe and effective
Yes sir $$$$$$$$
Gilead Sciences, Inc. GILD primarily focuses on developing drugs for the treatment of HIV, liver, hematology/oncology and inflammation/respiratory diseases. It is looking to diversify its business as the HCV business has lost sheen. The HIV business maintains momentum for the company, driven by Biktarvy. The company is also bolstering the oncology pipeline with collaborations. Importantly, the company has been in the news from the onset of the year owing to its promising experimental coronavirus treatment, remdesivir. It recently reported mixed results from a late-stage study on investigational antiviral, remdesivir, in hospitalized patients with moderate COVID-19 pneumonia. The FDA has also granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic. The drug is currently approved in Japan as a treatment for patients infected with COVID-19. A potential approval of remdesivir will be a significant boost for the company.
Gilead currently carries a Zacks Rank #2 (Buy).
America is starting to reopen its economy, and this is great news for tourism companies like Carnival Corporation (NYSE:CCL) (NYSE:CUK). The cruise ship operator has seen its share price rocket from a low of $7.80 in early April to $19.44 as of Monday's market close. That's a 149% surge in two and a half months, and the rally looks far from over. While nothing is guaranteed, the battered tourism company has several bullish tailwinds that could send its share price even higher.
First, governments are beginning to lift restrictions on tourism. Second, Carnival can survive in a low-revenue environment because of its strong balance sheet and liquidity. And finally, the company's valuation is still very low compared to its pre-crisis revenue and earnings.
Animation of a cruise ship sailng through troubled waters.
IMAGE SOURCE: GETTY IMAGES.
The tourism industry is reopening
Travel and tourism make up around 10.4% of global GDP, and governments around the world have big incentives to reopen the industry in time for the lucrative summer season. Things seem to be moving faster in Europe, where countries are further along the pandemic curve.
German river cruise operator Nicko Cruise was the first European line to resume voyages. And Connecticut-based American Cruise Lines is resuming trips in June. The company plans to sail out of Portland, Oregon, and traverse the Columbia and Snake Rivers despite the CDC-mandated No Sail Order.
Small operators like American Cruise Lines (whose ships carry fewer than 200 people) can skirt the No Sail Order because the restrictions apply only to ships carrying 250 or more passengers. But large operators like Carnival will have to wait until the order expires on July 24 before they can start sailing again. Investors should keep in mind that the order can be lifted sooner if the Secretary of Health and Human Services decides the public health emergency is over -- or it can be extended if the authorities decide cruising is still too risky.
Carnival has a solid balance sheet
The good news is that Carnival is well equipped to survive in a low-revenue environment until restrictions are lifted. That's because the company has a respectable pile of cash on its balance sheet and has drastically reduced its expenses.
Carnival raised a combined $6.4 billion in debt and equity financing to help shore up its liquidity. On top of that, the company has announced a combination of layoffs, reduced workweeks, and salary reductions that are expected to save hundreds of millions of dollars annually. According to CEO Arnold Donald, Carnival has enough liquidity to meet all its obligations in a zero-revenue environment for the rest of 2020, which would be a worst-case scenario.
Arnold further states that 2021 cruise bookings are strong. And competitor Norwegian Cruise Lines reports that 2021 bookings are within historical ranges despite higher prices. This is important because the cruise industry will probably need to sail at reduced capacity to ensure safety onboard, which could lead to a situation where demand outstrips supply, giving the industry better pricing power.
Carnival also plans to stagger fleet reentry to optimize its operations based on demand and doesn't expect any demand issues in the start-up period of operations.
A high-risk/high-reward investment
Carnival Corporation remains a risky stock, despite the bullish headwinds. That's because the company faces risk from things outside its control such as a possible second wave of coronavirus or an extension of the CDC's No Sail Order. Meanwhile, the $6.4 billion of debt and equity financing raised earlier this year will expose investors to dilution and higher interest expense over the long term.
With that being said, Carnival stock is still trading 64% below its pre-pandemic 52-week high of $53.34. This suggests that there is still potential for the shares to bounce back when things return to normal. The company's strong balance sheet and the reopening of the tourism industry make the stock worth considering for risk-tolerant investors who believe in the long-term success of the cruise industry.
Party just took off again $$$$$$$
That balloon must b filled with helium, NOT LED $$$$$$$$$
Gilead first launched studies of its antiviral drug remdesivir as a potential treatment for patients infected with the novel coronavirus on Feb. 26. The U.S. Food and Drug Administration (FDA) had just accepted the company's investigational drug filing to use remdesivir as a coronavirus treatment. At the time, the company stated it was launching two phase 3 open-label human trials, mainly focusing on patients in Asian countries and other locations where the rate of infection was high. To date, studies have been conducted at over 180 trial sites globally.
On April 10, the first wave of data on the efficacy of remdesivir from a cohort analysis of 53 critically ill coronavirus patients was released and published in the New England Journal of Medicine. Gilead's April 10 press release noted the following findings:
Nearly two-thirds of patients ... were on mechanical ventilation at baseline. ... Treatment with remdesivir resulted in an improvement in oxygen support class for 68 percent of patients ... over a median follow-up of 18 days from the first dose of remdesivir. More than half of patients on mechanical ventilation were extubated ... and nearly half of all patients ... were discharged from the hospital following treatment with remdesivir.
On April 29, the first concrete findings from two studies on remdesivir came through. One set of findings was from a placebo-controlled study run by the National Institute of Allergy and Infectious Diseases, while the other was data from one of Gilead's phase 3 human trials of the drug studying critically ill patients who had been hospitalized with COVID-19. The findings from both studies were positive, with the data from Gilead's in-house study revealing that severely ill coronavirus patients who had taken remdesivir in a five-day dosage period made similar strides toward recovery as patients administered the drug over a 10-day treatment course.
Shortly after the release of this encouraging data, Gilead announced on May 1 that the FDA had issued an emergency use authorization (EUA) for remdesivir. The EUA means that hospitals across the country have FDA authorization to use remdesivir to treat individuals severely ill with COVID-19 on either the five or 10-day dosage duration, depending on the patient's condition. Gilead noted that the U.S. government would be overseeing the distribution of the drug to hospitals in cities with the highest infection rates, and that "...hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir."
On June 1, the much-awaited results of Gilead's second phase 3 human study, this one of moderately ill coronavirus patients, were released. The trial dosed participants with moderate cases of COVID-19 on five and 10-day regimens of remdesivir, in co-occurrence with the standard of care treatment. A third group received the standard of care only. Both the five and 10-day dosage regimens produced positive outcomes for moderately ill coronavirus patients. However, the most notable improvements were recorded in moderately ill COVID-19 patients who took remdesivir for five days, as they "...were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group."
Gilead has pledged to donate about 1.5 million doses of remdesivir to ongoing clinical trials and through its expanded access and compassionate use programs. Japan approved the use of the drug on May 7 and is the first country to do so. Elsewhere, remdesivir is still being used as an investigational drug. Singapore just granted conditional approval of remdesivir.
A possible merger?
Another bit of news that captured investor attention last week was Bloomberg's report that multinational pharmaceutical and biopharmaceutical company AstraZeneca (NYSE:AZN) was in talks with Gilead about a prospective merger. Given Gilead's current market valuation just under $100 billion, and AstraZeneca's astonishing $140 billion valuation, it's no surprise that investors were champing at the bit at the prospect of what would be the largest ever pharma merger.
The hype was short-lived, it would seem, as The Times reported on June 8 that the idea of a potential merger had effectively been scrapped. One possible reason for this rapid shift is the fact that AstraZeneca is working on its own manufacturing deals in the race to get a COVID-19 vaccine in the hands of the public, one of which is in partnership with the University of Oxford. While it's highly possible that Gilead could be eyeing potential merger opportunities for down the line, the company's strong product portfolio and core valuation make this stock one to watch regardless.
Keep your eyes on Gilead
I previously maintained that Gilead Sciences stock is not one for risk-averse investors, the chief reason for this being that the hype surrounding remdesivir may be overinflating shares. Of course, investing with a long-term mindset is about striking that intricate balance of risk vs. reward.
There's also been measured skepticism about the long-term effect that remdesivir could have on Gilead's top and bottom line since the company has essentially been giving the drug away free of charge. While the company's future pricing of the drug remains unknown, some analysts are starting to predict blockbuster success for remdesivir.
In early June, SVB Leerink analyst Geoffrey Porges changed his previously modest assessment of the drug's future profit potential, stating that he projects remdesivir sales could hit $7.7 billion by the year 2022. Porges stated that remdesivir could cost approximately $5,000 per course in the U.S. market and $4,000 per course in Europe. We should know more about Gilead's pricing structure for the drug in the coming months. One thing's for sure, though. If sales of remdesivir get anywhere close to Porges' valuation, investors could be sitting on a veritable gold mine.
Israel is in advanced talks to buy Moderna Inc.’s (MRNA) experimental coronavirus vaccine candidate, the country’s news portal Ynet reported.
The talks come after Moderna last week announced that it is commencing with the late-stage testing of its COVID-19 vaccine candidate, mRNA-1273, according to the report, which cited unnamed officials at Israel’s Health Ministry. Additional details weren’t provided.
The biotech company, which has already finalized the Phase 3 study protocol for the vaccine candidate is expected to start a trial of 30,000 participants enrolled in the U.S. in July. The trial’s primary endpoint will be the prevention of symptomatic COVID-19 disease, while key secondary endpoints include prevention of infection by SARS-CoV-2, the virus that causes the disease.
Shares in Moderna more than tripled this year, as investors piled into the stock amid hopes for the potential of its virus vaccine. The stock rose 3% to $62 on Friday.
It looks like the rally has not yet run out of steam. Five-star analyst Edward Tenthoff at Piper Sandler last week reiterated a Buy rating on the stock with a $100 price target (61% upside potential) after the company finalized the Phase III trial protocol for the vaccine candidate.
Tenthoff added that Moderna has already completed mRNA-1273 manufacturing required to begin Phase III trial vaccinations in July with supply agreements supporting manufacturing of 500 million to 1 billion 100 microgram doses per year.
The rest of the Street has a bullish stance on Moderna’s stock. It boasts 11 Buy ratings versus 2 Hold ratings which add up to a Strong Buy consensus. Despite the recent share bonanza, the $90.40 average price target still indicates another 46% upside potential from current levels
A study of Moderna Inc's COVID-19 vaccine in mice lends some assurance that it will not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday.
Prior studies on a vaccine for SARS - a close cousin to the new virus that causes COVID-19 - suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response.
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Scientists have seen this risk as a key hurdle that must be cleared before vaccines can be safely tested in thousands of healthy people.
While the data released by the U.S. National Institutes of Allergy and Infectious Disease (NIAID) and Moderna was encouraging, mouse data is no guarantee of what will happen in humans.
The vaccine is currently in midstage testing in healthy volunteers. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July.
In the new study, six-week-old mice received one or two shots of a variety of doses of Moderna's vaccine, including doses considered not strong enough to elicit a protective immune response. Researchers then exposed the mice to the virus.
Subsequent analyses looking for signs of disease enhancement suggests that "sub-protective" immune responses do not cause what is known as vaccine-associated enhanced respiratory disease, a susceptibility to more severe disease in the lungs.
"Subprotective doses did not prime mice for enhanced immunopathology following (exposure)," Dr. Barney Graham of the Vaccine Research Center at NIAID and colleagues wrote in the not yet peer reviewed manuscript, posted on the bioRxiv website.
Further testing also suggested that the vaccine induces potent neutralizing antibody responses - the type of response needed to block the virus from infecting cells.
The vaccine also appeared to protect against infection by the coronavirus in the lungs and noses without evidence of toxic effects, the team wrote.
They noted that the mice that received just one dose of the vaccine before exposure to the virus seven weeks later were "completely protected against lung viral replication," suggesting that a single vaccination prevented the virus from making copies of itself in the lungs.
"At first glance, it looks promising in inducing neutralizing antibody protection in mice," Dr. Peter Hotez, a vaccine researcher at Baylor College of Medicine said in an email. He had not yet reviewed the paper in detail. (Reporting by
Indian drugmaker Zydus Cadila said on Friday it signed a non-exclusive licensing pact with Gilead Sciences Inc to manufacture and market antiviral drug remdesivir, the first treatment to show improvement in COVID-19 trials.
Zydus, listed as Cadila Healthcare, joins other Indian pharmaceutical companies Cipla Ltd, Jubilant Sciences Ltd and privately held Hetero Labs Ltd in signing non-exclusive pacts with Gilead for the drug.
Clinical studies involving the drug are being closely watched as nations look for treatments for the disease that has infected more than 7 million people and killed over 400,000 globally.
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The drug, intravenously administered in hospitals, has already been approved for emergency use in severely-ill patients in the United States, India and South Korea.
As part of the pact, Zydus will get the manufacturing know-how from Gilead to manufacture the active pharmaceutical ingredient for remdesivir and the finished product. Zydus will market it in 127 countries, including India.
India's novel coronavirus cases on Friday jumped by a record 10,956 from the previous day, and the death toll reached 8,498. Worldwide death toll was 420,950 on Friday.
The largest oil exchange traded fund was cleared by U.S. regulators to issue 1 billion new shares, paving the way for renewed investments into the popular retail product that’s been at the center of controversy in recent months.
The Securities and Exchange Commission approval comes nearly 8 weeks after the United States Oil Fund said that it issued all remaining registered shares, a move driven by tremendous interest in the sector as crude prices plunged into negative territory for the first time in history. In that period, it’s been subject to limits from the world’s biggest commodity exchanges, had to find new brokers and even found itself subject to regulatory investigations.
The $4.9 billion ETF, known by its ticker USO, has came under close scrutiny as oil’s rapid plunge forced it to quickly shift some of its giant positions on short notice. While West Texas Intermediate crude is down about 40% so far this year, USO has lost more than 70% of its value, becoming unhinged from tracking just the front-month futures contract due to restrictions from various regulators and brokers.
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Both the SEC and the Commodity Futures Trading Commission have opened probes into USO, people familiar with the matter said late last month, examining whether its risks were properly disclosed.
Read More: For Creators of USO ETF, Troubles in Market Began a Decade Ago
While its ability to accept new money has been halted, United States Commodity Funds, which runs USO, has been actively signing agreements with new brokers, including Marex Spectron and ED&F Man. The moves supplement an existing agreement with RBC Capital Markets, whose risk mitigation measures had stopped the fund from being able to add more exposure.
Throughout April and May, the ETF roiled oil prices after receiving record inflows from investors trying to call the bottom in crude’s rout. Its position in the June WTI contract at one point grew to represent 30% of the total open interest, worrying some about its outsized impact in the market.
The growing scale prompted CME Group Inc., the exchange, to instruct it to limit its position in several futures contracts. That forced it to spread its holdings out to different contracts for delivery as far in the future as June 2021, reducing its impact on any single calendar month.
Some of the USO’s stress has also been felt on other similar products after crude’s tumble toward negative $40 a barrel on April 20 forced issuers into a series of unusual steps. The broker for the $500 million Samsung S&P GSCI Crude Oil ER Futures ETF, for example, in early May restricted any new buying of crude futures. Royal Dutch Shell Plc forced the $500 million WisdomTree ETP to shut down amid increased scrutiny of how retail investors are punting in the oil market. Others had to delist completely.
Moderna (MRNA) closed the most recent trading day at $60.20, moving +0.22% from the previous trading session. The stock outpaced the S&P 500's daily loss of 5.89%. Elsewhere, the Dow lost 6.9%, while the tech-heavy Nasdaq lost 5.27%.
Wall Street will be looking for positivity from MRNA as it approaches its next earnings report date. On that day, MRNA is projected to report earnings of -$0.40 per share, which would represent year-over-year growth of 2.44%. Meanwhile, our latest consensus estimate is calling for revenue of $19.83 million, up 51.63% from the prior-year quarter.
For the full year, our Zacks Consensus Estimates are projecting earnings of -$1.51 per share and revenue of $114.42 million, which would represent changes of +2.58% and +90.03%, respectively, from the prior year.
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It is also important to note the recent changes to analyst estimates for MRNA. These revisions typically reflect the latest short-term business trends, which can change frequently. As such, positive estimate revisions reflect analyst optimism about the company's business and profitability.
Based on our research, we believe these estimate revisions are directly related to near-team stock moves. Investors can capitalize on this by using the Zacks Rank. This model considers these estimate changes and provides a simple, actionable rating system.
The Zacks Rank system, which ranges from #1 (Strong Buy) to #5 (Strong Sell), has an impressive outside-audited track record of outperformance, with #1 stocks generating an average annual return of +25% since 1988. Over the past month, the Zacks Consensus EPS estimate has moved 6.53% lower. MRNA currently has a Zacks Rank of #3 (Hold).
The Medical - Biomedical and Genetics industry is part of the Medical sector. This industry currently has a Zacks Industry Rank of 33,