New Products/Services – Page 3

China Approves Merck’s Molnupiravir for Emergency Use, Regulator Says

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China’s top drug regulator said Friday that it approved Merck & Co.’s Molnupiravir for emergency use on Thursday, as the country grapples with waves of infections after Beijing abruptly reversed its stringent Covid-19 restrictions earlier this month.

The National Medical Products Administration said it is requiring the approval holder to continue relevant research, complete conditional requirements and submit follow-up research results in a timely manner, according to a statement posted on its website Friday.

Write to Singapore Editors at singaporeeditors@dowjones.com

Corrections & Amplifications

This item was corrected at 0856 GMT to reflect China’s top drug regulator said it approved Merck & Co.’s Molnupiravir for emergency use on Thursday. The original version incorrectly said the approval came on Wednesday in the first paragraph.

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December 30, 2022

FTC sues to block Microsoft’s $69 billion acquisition of game giant Activision Blizzard

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The Federal Trade Commission on Thursday sued Microsoft Corp. to block its $69 billion deal to buy Activision Blizzard Inc.

The acquisition, which would be Microsoft’s
MSFT,
+1.07%
largest and the biggest ever in the video gaming industry, would “enable Microsoft to suppress competitors to its Xbox gaming consoles and its rapidly growing subscription content and cloud-gaming business,” the FTC claimed.

“Microsoft has already shown that it can and will withhold content from its gaming rivals,” Holly Vedova, director of the FTC’s Bureau of Competition, said in a statement. “Today we seek to stop Microsoft from gaining control over a leading independent game studio and using it to harm competition in multiple dynamic and fast-growing gaming markets.”

FTC members pointed to Microsoft’s record of “acquiring and using valuable gaming content to suppress competition from rival consoles,” including its acquisition of ZeniMax, parent company of Bethesda Softworks.

Microsoft President Brad Smith indicated the software giant will fight the lawsuit. In a statement, he said Microsoft has “been committed since Day One to addressing competition concerns.”

“While we believed in giving peace a chance, we have complete confidence in our case and welcome the opportunity to present our case in court,” Smith said.

Activision CEO Bobby Kotick, in a statement, said the suit “sounds alarming, so I want to reinforce my confidence that this deal will close. The allegation that this deal is anti-competitive doesn’t align with the facts, and we believe we’ll win this challenge.”

Still, In recent weeks Microsoft has taken steps to demonstrate to regulators its acquisition of Activision would not give it an unfair advantage in the gaming market. On Tuesday, Microsoft said it would bring the “Call of Duty” franchise to Nintendo Co.’s
7974,
-1.31%
Switch, a rival of Microsoft Xbox, and Microsoft has said it would make Call of Duty available on rival Sony Group Corp.’s
SONY,
-0.06%
PlayStation.

“It’s a bad idea,” Geoffrey Manne, president of the International Center for Law and Economics, said of the FTC’s lawsuit vs. Microsoft. “There may be markets in which some activities of some of these large tech companies cause concerns, but when they are expanding into new markets or enhancing competition in markets where they aren’t leaders, we should be encouraging them, not threatening them with lawsuits.”

The government’s action in administrative court marks the first serious regulatory threat to Microsoft’s business in more than two decades, when the Justice Department brought a landmark antitrust lawsuit against the software giant that took years and was settled in 2002. Since then, Microsoft had sidestepped antitrust scrutiny and Smith in particular has focused the glare on its tech rivals Amazon.com Inc.
AMZN,
+2.24%,
Apple Inc.
AAPL,
+1.19%,
Alphabet Inc.’s
GOOGL,
-0.94%

GOOG,
-0.89%
Google, and Facebook parent company Meta Platforms Inc.
META,
+1.26%.

Shares of Microsoft are up 1% in trading Thursday. Activision’s
ATVI,
-1.33%
stock is down 1.5%.

The FTC’s lawsuit comes the same day it is heading to court in San Jose, Calif., in what is expected to be a three-week trial to bloc Meta’s $300 million acquisition of VR fitness app maker Within.

The trial is likely to showcase an intriguing look at the agency’s ability to stifle alleged anticompetitive conduct using largely untested legal theories at a time when Congress is sitting on tech antitrust legislation.

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December 8, 2022

BioVie Shares jump Premarket on Parkinson’s, Alzheimer’s Studies >BIVI

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By Colin Kellaher

Shares of BioVie Inc. rose sharply in premarket trading Tuesday after the clinical-stage biopharmaceutical company reported positive results from a pair of Phase 2 studies assessing the potential of its NE3107 drug candidate in Parkinson’s disease and Alzheimer’s disease.

The Carson City, Nev., company said the study of NE3107 in Parkinson’s met both main objectives, with patients treated with a combination of the drug and levodopa seeing meaningful improvements in their motor score and an absence of adverse interactions of NE3107 with levodopa.

BioVie said that based on the study findings, it will proceed with planning the Phase 3 program for discussion with the U.S. Food and Drug Administration.

Meanwhile, BioVie said patients treated with NE3107 in the Alzheimer’s study experienced improved cognition and biomarker levels, with no drug-related adverse events observed.

BioVie shares, which closed Monday at $5.21, were recently up 15% to $5.98 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

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December 6, 2022

This record number in Nvidia earnings is a scary sight

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Nvidia Corp.’s financial results had a bit of a surprise for investors, and not on the good side — product inventories doubled to a record high as the chip company gears up for a questionable holiday season.

Nvidia reported fiscal third-quarter revenue that was slightly better than analysts’ reduced expectations Wednesday, but the numbers weren’t that great. Revenue fell 17% to $5.9 billion, while earnings were cut in half thanks to a $702 million inventory charge, largely relating to slower data-center demand in China.

Gaming revenue in the quarter fell 51% to $1.57 billion. Nvidia said it is working with its retail partners to help move the currently high-channel inventories.

While the company was writing off the inventory for China, its own new product inventory was growing. Nvidia
NVDA,
-4.54%
reported that its overall product inventory nearly doubled to $4.45 billion in the fiscal third quarter, compared with $2.23 billion a year ago and $3.89 billion in the prior quarter. Executives cited its coming product launches, designed around its new Ada and Hopper architectures, when asked about the inventory gains.

In the semiconductor industry, high inventories can make investors nervous, especially after the industry had so many supply constraints in recent years that quickly swung to a glut of chips in 2022. With doubts about demand for gaming cards and consumers’ willingness to spend amid sky-high inflation this holiday season, having all that product on hand just amps up the nerves.

Full earnings coverage: Nvidia profit chopped in half, but tweaked servers to China offset earlier $400 million warning

Chief Financial Officer Colette Kress told MarketWatch in a telephone interview Wednesday that the company’s high level of inventories were commensurate with its high levels of revenue.

“I do believe….it is our highest level of inventory,” she said. “They go hand in hand.” Kress said she was confident in the success of Nvidia’s upcoming product launches.

Nvidia’s revenue reached a peak in the April 2022 quarter with $8.3 billion, and in the past two quarters revenue has slowed, with gaming demand sluggish amid a transition to a new cycle, and a decline in China data-center demand due to COVID-19 lockdowns and U.S. government restrictions.

For its data-center customers, the new architectures promise major advances in computing power and artificial-intelligence features, with Nvidia planning to ship the equivalent of a supercomputer in a box with its new products over the next year. Those types of advanced products weigh on inventory totals even more, Kress said, because of the price of the total package.

“It’s about the complexity of the system we are building, that is what drives the inventory, the pieces of that together,” Kress said.

Bernstein Research analyst Stacy Rasgon believes that products based on Hopper will begin shipping over the next several quarters, “at materially higher price points.” He said in a recent note that he believes Nvidia’s numbers were likely hitting a bottom in this quarter.

“We remain positive on the Hopper ramp into next year, and believe numbers have at this point likely reached close to bottom, with new cycles brewing and an attractive secular story even without China potential,” Rasgon said in an earnings preview note Tuesday.

Nvidia Chief Executive Jensen Huang reminded investors on a conference call that the company’s inventories are “never zero,” and said everyone is enthusiastic about the upcoming launches. But it doesn’t take too long of a memory to conjure up a time when Nvidia went into a holiday with an inventory backlog that included new architecture and greatly disappointed investors: Four years ago, Huang had to cut his forecast for holiday earnings twice amid a “crypto hangover” with similar dynamics to the current moment

Investors need faith that this holiday season will not be the same, even as demand for some videogame products declines after a pandemic boom just as the market for cryptocurrency — some of which has been mined with Nvidia products — hits a rough patch. Huang said that Nvidia’s RTX 4080 and 4090 graphics cards based on the Ada Lovelace architecture had an “exceptional launch,” and sold out.

Nvidia shares gained more than 2% in after-hours trading Wednesday, suggesting that some are betting that this time will be different. That enthusiasm needs to translate into revenue for Nvidia so that this big gain in inventories does not end up being part of another write-down at some point in the future.

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November 16, 2022

GSK Says Dreamm-3 Phase 3 Study For Blenrep Didn’t Meet Primary Endpoint

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By Michael Susin

GSK PLC said Monday that its Dreamm-3 Phase 3 study in patients with relapsed or refractory multiple myeloma didn’t meet its primary endpoint of progression-free survival.

The pharmaceutical giant said that the study compared its monotherapy Blenrep versus pomalidomide in combination with low dose dexamethasone and observed median progression-free survival was longer for Blenrep.

“These trials are designed to demonstrate the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimization to maintain efficacy while reducing corneal events,” it added.

The company said additional trials will continue and further data from the studies are anticipated in the first half of 2023.

Write to Michael Susin at michael.susin@wsj.com

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November 7, 2022

Apple earnings beat as record back-to-school Mac sales outweigh a slight miss on iPhones

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At the end of a woeful week for Big Tech earnings, Apple Inc. managed to top expectations on revenue and earnings with the help of Macs selling at a record pace during the back-to-school season, which outweighed a slight miss on iPhone sales.

Apple
AAPL,
-3.05%
shares bounced between slight gains and losses in after-hours action Thursday, even as executives projected that revenue growth could slow in the holiday quarter. As has been the case throughout the COVID-19 pandemic, Apple executives declined to offer a traditional financial forecast, but Chief Financial Officer Luca Maestri told investors on a conference call that they expect a sequential slowdown in growth during the December quarter, driven in part by sharp currency impacts, tough comparisons for the Mac business and pressures on the services business.

The smartphone giant’s revenue grew 8% in its fiscal fourth quarter, to $90.1 billion from $83.4 billion a year earlier, and came in ahead of the FactSet consensus of $88.7 billion. Apple generated $42.6 billion in its biggest business, iPhone sales, up from $38.9 billion a year before, but analysts were projecting $43.0 billion.

A big driver of the upside came from Apple’s
AAPL,
-3.05%
Mac segment, which posted a massive beat even as iPhone sales came up light. The Mac business set an all-time quarterly revenue record at $11.5 billion in the back-to-school quarter, up from $9.2 billion a year before and easily above the FactSet consensus, which called for $9.3 billion.

Chief Executive Tim Cook explained on the call that the Mac category benefited from the launch of the MacBook Air with Apple’s custom M2 chip, as well as easing supply constraints that allowed Apple to meet a prior demand backlog. Maestri said he expects that Mac revenue will “decline substantially” on a year-over-year basis in the December quarter, however, as that period faces tough comparisons.

A key question coming into Apple’s report was how demand for the company’s new iPhone 14 line has held up, especially given reports that the company has scaled back earlier production goals. Cook shared that while it was still early, “consumer demand was strong and better than we anticipated that it would be.”

The company is supply-constrained on the iPhone 14 Pro and iPhone 14 Pro Max models, Cook said, adding that it is difficult for the company to “determine the accurate mix” of its phones until it is able to fulfill all of its demand.

Revenue performance across Apple’s product lines was mixed. While Mac sales were strong, iPad revenue fell to $7.2 billion from $8.3 billion, whereas analysts were modeling $7.8 billion in iPad revenue. That category saw “opposite” trends relative to the Mac business in that iPads were up against an “exceptionally strong iPad quarter” from a year before that included a product launch.

The company raked in $9.7 billion in revenue across its wearables, home and accessories category, up from $8.8 billion in the same period a year ago. Analysts had expected revenue of $9.2 billion.

Services revenue climbed to $19.2 billion from $18.3 billion but fell short of the FactSet consensus, which was for $20.0 billion. Maestri shared that while he expects the segment to grow in the December quarter, the business could be impacted by pressures on advertising and gaming, as well as foreign-exchange effects.

For the latest quarter, Apple recorded net income of $20.7 billion, or $1.29 a share, compared with $20.6 billion, or $1.24 a share, in the year-earlier period. Analysts tracked by FactSet were expecting $1.27 a share in earnings.

If Apple’s stock managed to hold gains through Friday’s close, it would likely be the only Big Tech company to see positive post-earnings stock performance this week. Shares of Microsoft Corp.
MSFT,
-1.98%,
Alphabet Inc.
GOOG,
-2.34%

GOOGL,
-2.85%,
and Meta Platforms Inc.
META,
-24.56%
each posted sharp declines in the session after their respective reports, and Amazon.com Inc.
AMZN,
-4.06%
shares were off 12% in late trading Thursday.

Shares of Apple have lost 18% so far this year, as the Dow Jones Industrial Average
DJIA,
+0.61%
— which counts Apple as one of its 30 components — has declined 12%.

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October 27, 2022

Moderna Stock Takes Off on Cancer Vaccine News

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Moderna

stock shot up after

Merck

said it is exercising an option to work on a personalized cancer vaccine with the Covid-19 vaccine maker.

Merck (ticker: MRK) will pay

Moderna

(MRNA) $250 million for the joint development and future commercialization of the vaccine, which is currently in Phase 2 clinical trials. The two companies had announced a “strategic collaboration” in June 2016.

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October 12, 2022

Tag: New Products/Services