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Moderna says preliminary trial data shows its coronavirus vaccine is more than 94% effective, shares soar

Moderna said preliminary phase three trial data shows its coronavirus vaccine is more than 94% effective in preventing Covid-19….

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Moderna said preliminary phase three trial data shows its coronavirus vaccine is more than 94% effective in preventing Covid-19 — a result CEO Stephane Bancel called a “game changer.”

The analysis evaluated 95 confirmed Covid-19 infections among the trial’s 30,000 participants. Moderna, which developed its vaccine in collaboration with the National Institute of Allergy and Infectious Diseases, said 90 cases of Covid-19 were observed in the placebo group versus five cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 94.5%, it said.

Shares of the company jumped more than 12% in premarket trading.

The announcement comes on the heels of similar news last week from Pfizer‘s late-stage Covid-19 vaccine trial as pharmaceutical companies across the world race against the clock to find ways to prevent the virus, which has spread to more than 54.4 million people, killing more than 1.3 million, according to data compiled by Johns Hopkins University.

Health and Human Services Secretary Alex Azar told CNBC on Monday that U.S. Food and Drug Administration will move “as quickly as possible” to clear Pfizer and Moderna’s coronavirus vaccines for emergency use.

Bancel called it a “pivotal moment.”

“Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters,” he said in a statement. “This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”

The Cambridge, Massachusetts-based company also said there were no “significant” safety concerns, adding the vaccine was generally safe and well tolerated with the majority of adverse events in participants being labeled as mild or moderate. Side effects included pain at the injection site and, after the second dose, fatigue, muscle pain and headaches.

“Knowing that we have a vaccine that would help more people who would take it is just a wonderful feeling,” Bancel said in an interview with CNBC. “As you know a lot of people have been reluctant in surveys to take a vaccine because I think we’re worried about the politicization of a vaccine, they’re worried about what you get with a flu shot you know 50% to 60% efficacy.”

With an efficacy rate of 95%, “that’s a game changer, I believe,” he said.

Bancel said the company plans to test the vaccine in teens “very soon,” followed by children under the age of 12. “We have to be very, very careful because safety is priority No. 1,” he said in a separate interview on CNBC’s “Squawk Box,” adding most trials test vaccines on healthy adults first to assess safety.

Investors were expecting Moderna‘s vaccine to be highly effective after Pfizer, another front-runner in the Covid-19 vaccine race, said last week that its product was more than 90% effective. Moderna’s candidate, like that of the Pfizer-BioNTech partnership, is using messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response.

Medical experts note it remains unclear how long the vaccine provides immunity and whether or how often people may need periodic booster shots.

“These vaccines are going to be approved and then rolled out with basically a few months worth of data. You’re not going to do a two-year study to see whether it’s effective for two years with more than 200,000 people dying this year” in the U.S., said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Dr. Soumya Swaminathan, the World Health Organization’s chief scientist, said other questions remain about the vaccine, including whether it decreases the infectiousness of the virus and whether it is highly effective in subgroups like the elderly. She said the WHO-backed COVAX initiative is also thinking about the equitable distribution of the vaccine, which will initially be in short supply.

“We’re looking at at least the first half of next year as being a period with very, very limited doses,” she said. “Supplies are going to be limited. There are bilateral deals that many of the companies have done. So many of the doses have already been booked by some countries.”

Moderna said Monday its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at negative 4 degrees Fahrenheit. By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

On a call with reporters Monday, Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the promising data from Pfizer and Moderna doesn’t mean people should let their guard down, urging Americans to continue to wash their hands, wear masks and maintain their distance from others.

Moderna told investors on Oct. 29 that it was “actively preparing” for the global launch of its potential vaccine after completing enrollment in its phase three trial a week earlier. It said about 37% of the participants were from minority communities and 42% had other conditions or ages that put them at high risk of severe disease. Males outnumber females in the trial by 53% to 47%.

Out of the 95 Covid-19 cases, 20 participants identified as being from “diverse” communities, including 12 Hispanic people, four African Americans, three Asian Americans and one multiracial. Fifteen were adults over the age of 65.

Moderna said it plans to apply for emergency use authorization from the Food and Drug Administration in “the coming weeks.” The trial will continue to accrue additional data relevant to safety and efficacy even after an application is submitted, the company said.

By the end of the year, Moderna expects to have approximately 20 million doses of the vaccine ready to ship in the U.S., the company said. It said it remains on track to manufacture 500 million to 1 billion doses globally in 2021.

Between Moderna and Pfizer, Azar told CNBC there will be roughly 40 million doses of vaccine available by the end of this year, enough to inoculate about 20 million people since both vaccines require two shots. The goal is to provide enough coronavirus vaccine doses to all Americans who want to be vaccinated against the disease by the second quarter of 2021, Azar said.

The company already has supply agreements in North America, the Middle East and in other regions of the world. It announced in August that it had reached a deal with the U.S. government to supply 100 million doses of its vaccine. The deal gives the federal government the option to purchase up to 400 million additional doses. The U.S. had already invested $955 million in Moderna’s Covid-19 vaccine development, bringing its total investment up to $2.48 billion, the company said at the time.

In August, Moderna said it was charging between $32 and $37 per dose for its vaccine for some customers, under cheaper “pandemic pricing.” The company said it was in discussion for larger volume agreements that will have a lower price.

– CNBC’s Meg Tirrell and Noah Higgins-Dunn contributed to this report.

Source: https://www.cnbc.com/2020/11/16/moderna-says-its-coronavirus-vaccine-is-more-than-94percent-effective.html

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Oracle guidance misses expectations, stock drops

Oracle reported better-than-expected results and showed accelerating growth compared with the immediate impact of the coronavirus last year.

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Safra Catz, co-chief executive officer of Oracle Corp.

David Paul Morris | Bloomberg | Getty Images

Oracle shares fell 5% in extended trading on Tuesday after the company offered lower quarterly revenue guidance than expected as it plans to increase capital expenditures to support cloud computing workloads. The guidance came on Oracle’s earnings call after the enterprise software maker issued better-than-expected earnings and faster revenue growth than last quarter.

Here’s how the company did:

  • Earnings: $1.54 per share, adjusted, vs. $1.31 per share as expected by analysts, according to Refinitiv.
  • Revenue: $11.23 billion, vs. $11.04 billion as expected by analysts, according to Refinitiv.

With respect to guidance, Oracle CEO Safra Catz called for 94 cents to 98 cents in adjusted earnings per share and 3% to 5% revenue growth in the fiscal first quarter. Analysts polled by Refinitiv are expecting fiscal first-quarter adjusted earnings of $1.03 per share and the equivalent of 3% revenue growth.

“We expect to roughly double our cloud capex spend in FY 2022 to nearly $4 billion,” Catz said. “We are confident that the increased return in the cloud business more than justifies this increased investment, and our margins will expand over time.”

Revenue rose 8% year over year in Oracle’s fiscal fourth quarter, which ended on May 31, according to a statement. In the prior quarter revenue grew 3%. The accelerating growth benefited from a comparison against the quarter last year when the coronavirus arrived in the U.S. and Oracle’s revenue fell some 6%.

Oracle’s top segment by revenue, cloud services and license support, generated $7.39 billion, which was up 8% and above the FactSet consensus estimate of $7.32 billion in revenue. The company said revenue from its second-generation cloud infrastructure doubled in the quarter, but it did not provide the figure in dollars.

The cloud license and on-premises license segment contributed $2.14 billion in revenue, up 9% and more than the $2.05 billion consensus.

The company’s hardware revenue, at $882 million, was exactly in line with analysts’ estimates, declining 2%.

During the quarter Oracle announced new public-cloud computing options that draw on Arm-based chips, and the U.S. Supreme Court ruled on a longstanding case between Oracle and Google, declaring that Google’s copying of Java code was fair use.

Notwithstanding the after-hours move, Oracle stock is up 26% since the start of the year, while the S&P 500 index is up 13% over the same period.

In May, Barclays analysts lowered their rating on the stock to the equivalent of hold from the equivalent of buy after the price had moved upward as investors rotated out of growth and into value. “To see further relative outperformance a growth acceleration at Oracle is needed, and we don’t have enough tangible data points for this yet,” the analysts wrote.

WATCH: The great tech tug-o-war

Here’s how the company did:

Source: https://www.cnbc.com/2021/06/15/oracle-orcl-earnings-q4-2021.html

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RH beats earnings, hikes outlook as retail rebound boosts high-end home goods; shares jump

Shares of the high-end furniture retailer surged Wednesday after the company beat analysts’ profit and sales estimates for the fiscal first quarter.

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Jason Kempin | Getty Images Entertainment | Getty Images

Shares of the high-end furniture retailer RH surged in extended trading Wednesday after the company beat analysts’ profit and sales estimates for the fiscal first quarter.

RH also hiked its full-year outlook, building on the momentum it’s seeing in the luxury home category, and gave a stronger-than-expected sales forecast for the second quarter.

In a letter to shareholders, Chief Executive Officer Gary Friedman said the remainder of this year “will surely be a tale of two halves” for the retail industry. But he said that “the un-masking of the general public could lead to a Roaring Twenties type of consumer exuberance.”

The company’s stock was last up more than 7%.

Here’s how RH did in the quarter ended May 1 compared with what analysts were anticipating, using Refinitiv estimates:

  • Earnings per share: $4.89 adjusted vs. $4.10 expected
  • Revenue: $861 million vs. $758 million expected

RH’s net income for the fiscal first quarter grew to $130.7 million, or $4.19 per share, compared with a loss of $3.2 million, or 17 cents per share, a year earlier. Excluding one-time adjustments, it earned $4.89 per share, topping expectations for $4.10.

Revenue surged 78% to $861 million from $483 million a year earlier. That also beat expectations for $758 million.

Friedman said that a strong housing and renovation market, a record stock market, low interest rates, and the reopening of the U.S. economy all bode well for the company in the quarters ahead.

RH hiked its fiscal 2021 outlook for revenue growth to a range of 25% to 30%, compared with a prior range of 15% to 20%. Analysts had been looking for a 19.7% increase year over year.

For its fiscal second quarter, RH expects revenue to grow 35% to 37%. Analysts had been looking for a 27.2% jump.

The company is preparing to kick off its global expansion in the spring of 2022, starting with England. To drive future growth, it is also considering expanding into new services, potentially into areas such as landscape architecture. It currently offers interior design consulting.

RH shares are up roughly 37% year to date. The company has a market cap of about $13 billion.

Find the full earnings press release from RH here.

Source: https://www.cnbc.com/2021/06/09/rh-earnings-q1-2021.html

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Blue Origin auctions seat on first spaceflight with Jeff Bezos for $28 million

The winning bidder will fly to the edge of space with the Amazon founder on Blue Origin’s New Shepard rocket scheduled to launch on July 20.

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A New Shepard rocket launches on a test flight.

Blue Origin

Jeff Bezos‘ space venture Blue Origin auctioned off a seat on its upcoming first crewed spaceflight on Saturday for $28 million.

The winning bidder, whose name wasn’t released, will fly to the edge of space with the Amazon founder and his brother Mark on Blue Origin’s New Shepard rocket scheduled to launch on July 20. The company said it will reveal the name of the auction winner in the coming weeks.

Bidding opened at $4.8 million but surpassed $20 million within the first few minutes of the auction. The auction’s proceeds will be donated to Blue Origin’s education-focused nonprofit Club for the Future, which supports kids interested in future STEM careers.

Blue Origin director of astronaut and orbital sales Ariane Cornell said during the auction webcast that New Shepard’s first passenger flight will carry four people, including Bezos, his brother, the auction winner and a fourth person to be announced later.

Autonomous spaceflight

New Shepard, a rocket that carries a capsule to an altitude of over 340,000 feet, has flown more than a dozen successful test flights without passengers, including one in April at the company’s facility in the Texas desert. It’s designed to carry up to six people and flies autonomously — without needing a pilot. The capsule has massive windows to give passengers a view of the earth below during about three minutes in zero gravity, before returning to Earth.

Blue Origin’s system launches vertically, and both the rocket and capsule are reusable. The boosters land vertically on a concrete pad at the company’s facility in Van Horn, Texas, while the capsules land using a set of parachutes.

The interior of the latest New Shepard capsule

Blue Origin

Bezos founded Blue Origin in 2000 and still owns the company, funding it through share sales of his Amazon stock.

July 20 is notable because it also marks the 52nd anniversary of the Apollo 11 moon landing.

Branson and Musk

VSS Unity fires its rocket engine shortly after launching on its third spaceflight on May 22, 2021.

Virgin Galactic

Bezos and fellow billionaires Elon Musk and Sir Richard Branson are in a race to get to space, but each in different ways. Bezos’ Blue Origin and Branson’s Virgin Galactic are competing to take passengers on short flights to the edge of space, a sector known as suborbital tourism, while Musk’s SpaceX is launching private passengers on further, multi-day flights, in what is known as orbital tourism.

Both Blue Origin and Virgin Galactic have been developing rocket-powered spacecraft, but that is where the similarities end. While Blue Origin’s New Shepard rocket launches vertically from the ground, Virgin Galactic’s SpaceShipTwo system is released mid-air and returns to Earth in a glide for a runway landing, like an aircraft.

Virgin Galactic’s system is also flown by two pilots, while Blue Origin’s launches without one. Branson’s company has also flown a test spaceflight with a passenger onboard, although the company has three spaceflight tests remaining before it begins flying commercial customers – which is planned to start in 2022.

SpaceX launches its Crew Dragon spacecraft to orbit atop its reusable Falcon 9 rocket, having sent 10 astronauts to the International Space Station on three missions to date.

In addition to the government flights, Musk’s company is planning to launch multiple private astronaut missions in the year ahead – beginning with the all-civilian Inspiration4 mission that is planned for September. SpaceX is also launching at least four private missions for Axiom Space, starting early next year.

Blue Origin’s auction may have netted $28 million, but a seat on a suborbital spacecraft is typically much less expensive. Virgin Galactic has historically sold reservations between $200,000 and $250,000 per ticket, and more recently charged the Italian Air Force about $500,000 per ticket for a training spaceflight.

Musk’s orbital missions are more costly than the suborbital flights, with NASA paying SpaceX about $55 million per seat for spaceflights to the ISS.

SpaceX’s Crew Dragon spacecraft named “Resilience” is seen docked to the International Space Station.

NASA

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The winning bidder, whose name wasn’t released, will fly to the edge of space with the Amazon founder and his brother Mark on Blue Origin’s New Shepard rocket scheduled to launch on July 20. The company said it will reveal the name of the auction winner in the coming weeks.

Source: https://www.cnbc.com/2021/06/12/jeff-bezos-blue-origin-auctions-spaceflight-seat-for-28-million.html

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