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The company — which has its COVID-19 vaccine as the only marketed product after 35 years in business — on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. "While there is the potential for a substantial booster market ... we don't expect Novavax to be a major player in the booster opportunity." As of last close, Novavax's U.S.-listed shares were down 97% from their February 2021 record high of $331.68.

The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer's (PFE.N) RSV vaccine, which was recommended by the FDA panel on Tuesday. Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts. There is currently no approved vaccine to prevent lower respiratory tract disease caused by RSV in older adults, which causes death of 14,000 adults aged 65 and older annually in the United States. In October, late-stage data of GSK's RSV vaccine showed it to be 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, while Pfizer's vaccine was 66.7% effective. If approved, we estimate peak sales for GSK vaccine to be about $2.8 billion globally, said Evan Wang, Guggenheim Securities analyst, ahead of the panel vote.

☆ Pfizer/BioNTech seeks U.S. nod for updated COVID vaccine as booster in kids under 5
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) have applied for emergency use authorization of their Omicron-adapted COVID-19 vaccine in the United States as a booster dose for children aged six months through four years, the companies said on Wednesday. The Omicron-adapted vaccine is currently authorized by the U.S. health regulator as the third dose of the three-dose primary course of vaccination in the country for children in this age group. If the Food and Drug Administration (FDA) authorizes the vaccine as a booster dose, children who have completed their primary series - either with three doses of the Pfizer-BioNTech's original vaccine or with two doses of their original and one dose of the adapted vaccine - would be eligible to receive the booster dose at least two months after the completion of their primary series. Last week, the companies also filed an application to the FDA for a full approval of their Omicron-adapted COVID vaccine as a primary course and a booster dose for individuals 12 years of age and above. Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ EU silence over Pfizer COVID contract talks is problem that won't go away -watchdog
▼ + stars: | 2023-03-01 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

[1/2] The European Ombudsman Emily O'Reilly speaks during an interview with Reuters in Brussels, Belgium February 28, 2023. The Commission said in June 2022 that it no longer had the texts, which later drew criticism from the EU ombudsman. O’Reilly argued many people would understand why von der Leyen approached Bourla to plead Europe’s case for vaccines, as tens of thousands of people on the continent were dying from COVID-19. It has proposed to other EU institutions that they do the same, the spokesperson added. In February, the New York Times said it was suing the Commission over failure to release the text messages.

Feb 28 (Reuters) - A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. GSK (GSK.L), which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. "The population where the vaccine is going to potentially have the biggest impact is less represented in this study," said Hana Sahly, one of the 12 FDA panelists. The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts. Pfizer's vaccine was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, while GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.

The stock had dropped 26.2% to $6.83 around 8:55 ET (13:55 GMT), while its Frankfurt-listed shares slumped more than 27%. The company - whose COVID vaccine is its only marketed product after 35 years in business - on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. As of last close, Novavax's U.S.-listed shares are down 97% from their February 2021 record high of $331.68.

☆ Covid vaccine maker Novavax says it may not survive
▼ + stars: | 2023-03-01 | by ( Paul R. La Monica | ) edition.cnn.com time to read: +2 min

New York CNN —Novavax, which makes the Nuvaxovid vaccine used to treat Covid-19, posted huge sales gains for the past three years during the height of the pandemic. But the company is now facing serious financial challenges — and has even warned it may not be able to survive. Shares of Novavax (NVAX) plunged more than 25% in early morning trading to a new multi-year low of under $7. Novavax hit a 52-week high of about $91 last year and was trading above $330 in February 2021. Novavax isn’t the only Covid-vaccine maker to disappoint Wall Street, though.

☆ Novavax raises doubts about ability to remain in business, shares fall
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Novavax's shares closed at $9.26 on Tuesday and fell to $6.90 in extended trading after reporting on its financial situation. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Merck scraps third prostate cancer study as Keytruda therapy disappoints
▼ + stars: | 2023-02-28 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

The setbacks were likely to put Merck further behind in its quest to develop a treatment for advanced forms of the most common cancer type in the United States. It had in January stopped a late-stage study of the drug in some prostate cancer patients. An interim analysis showed the combination therapy did not extend survival or help extend the time a patient lives without the disease worsening compared to placebo, Merck said. Merck was testing its blockbuster immunotherapy in combination with androgen deprivation therapy and Xtandi, made by Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T), in patients with an advanced form of treatment-resistant prostate cancer. Additionally, Merck said another combination treatment with Keytruda did not meet the main goal in a separate late-stage study for a type of lung cancer that can spread to other parts of the body.

☆ U.S. FDA panel votes for Pfizer's RSV vaccine
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: 1 min

Feb 28 (Reuters) - A panel of outside advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, paving the way for one of the first approved RSV shots in the United States for older adults. The FDA advisory committee voted 7 to 4 in favor of the drug, saying data from the clinical study conducted by the company established that the treatment was effective and safe in preventing the lower respiratory tract disease caused by RSV in 60 years and older. (This story has been corrected to change the voting ratio to "7 to 4" from "7 to 12" in paragraph 2)Reporting by Mariam E Sunny and Khushi Mandowara in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer, GSK face FDA panel review in race for RSV vaccines
▼ + stars: | 2023-02-28 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The frontrunners in a crowded race to develop the first respiratory syncytial virus (RSV) vaccine - Pfizer Inc (PFE.N) and GSK (GSK.L) - will face scrutiny from a panel of experts to the U.S. Food and Drug Administration this week. Merck & Co Inc (MRK.N), Moderna Inc (MRNA.O), Johnson & Johnson (JNJ.N) are conducting trials of their own RSV vaccines. Pfizer and GSK grabbed a lead last year after data from separate late-stage studies showed their shots prevented respiratory disease caused by RSV. GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, and 94.1% effective in preventing severe disease. Dr. Schaffner expects a positive vote on the vaccines when the advisory panel discusses Pfizer's vaccine on Feb. 28, and GSK's vaccine on March 1.

☆ Novavax raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, Feb 28 (Reuters) - COVID-19 vaccine maker Novavax Inc (NVAX.O) on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Stocks close slightly up after prior week's selloff
▼ + stars: | 2023-02-27 | by ( Chuck Mikolajczak | ) www.reuters.com time to read: +4 min

All three main stock indexes climbed more than 1% shortly after the opening bell, in part due to an easing in Treasury yields, and all three closed well off their session highs. Stocks steadily gave up gains throughout the session as U.S. Treasury yields moved off the day's lows. Traders work on the trading floor at the New York Stock Exchange (NYSE) in New York City, U.S., January 27, 2023. Advancing issues outnumbered declining ones on the NYSE by a 1.69-to-1 ratio; on Nasdaq, a 1.41-to-1 ratio favored advancers. The S&P 500 posted 4 new 52-week highs and 8 new lows; the Nasdaq Composite recorded 71 new highs and 102 new lows.

☆ Wall Street bounces modestly after prior week's selloff
▼ + stars: | 2023-02-27 | by ( Chuck Mikolajczak | ) www.reuters.com time to read: +4 min

Each of the three main indexes climbed more than 1% shortly after the opening bell, in part due to an easing in Treasury yields. The yield on two-year Treasury notes , which typically moves in step with interest rate expectations, slipped after touching a near four-month high. Seagen Inc (SGEN.O) surged 9.73% after the Wall Street Journal reported that Pfizer (PFE.N) was in early talks to acquire the biotech firm. Advancing issues outnumbered declining ones on the NYSE by a 2.30-to-1 ratio; on Nasdaq, a 1.66-to-1 ratio favored advancers. The S&P 500 posted four new 52-week highs and five new lows; the Nasdaq Composite recorded 58 new highs and 82 new lows.

☆ Pfizer in talks to buy cancer drugmaker Seagen - WSJ
▼ + stars: | 2023-02-27 | by ( ) www.reuters.com time to read: +2 min

Feb 27 (Reuters) - Pfizer Inc (PFE.N) is in early-stage talks to acquire cancer drugmaker Seagen Inc (SGEN.O) in a potential multi-billion dollar deal, the Wall Street Journal reported, after advanced discussions between Merck (MRK.N) and Seagen fell through last year. Seagen had a market capitalization of roughly $30 billion, as of Friday's close. Its shares have fallen nearly 10% since July, when the deal talks with Merck were first reported. Pfizer declined to comment on the WSJ report, while Seagen did not immediately respond to a Reuters request for comment. Merck, which bought ADC-maker Imago BioSciences for $1.35 billion in November, is unlikely to show renewed interest in Seagen, analysts said.

☆ Wall Street edges higher after last week's rout
▼ + stars: | 2023-02-27 | by ( Sruthi Shankar | ) www.reuters.com time to read: +4 min

"Some relatively significant losses last week is the starting point," said Art Hogan, chief market strategist at B Riley Wealth. "Also, when you look at the drivers last week, better-than-expected economic data pushed yields higher. The yield on two-year Treasury notes , the most sensitive to short-term rate expectations, slipped after touching a near four-month high earlier. Seagen Inc (SGEN.O) surged 10.5% after the Wall Street Journal reported that Pfizer (PFE.N) was in early talks to acquire the biotech firm. The S&P index recorded three new 52-week highs and three new lows, while the Nasdaq recorded 51 new highs and 64 new lows.

☆ Wall Street climbs after worst weekly selloff of 2023
▼ + stars: | 2023-02-27 | by ( Sruthi Shankar | ) www.reuters.com time to read: +4 min

"February historically is the second worst month of the year for the stock market. So investors are concluding from a seasonal perspective that maybe stocks could rally at least in the near term." The yield on two-year notes , the most sensitive to short-term rate expectations, slipped after touching a near four-month high earlier in the session. After last week's hawkish comments from the Fed policymakers, investors will turn to Fed Governor Philip Jefferson's speech later in the day. Seagen Inc (SGEN.O) surged 12.2% after the Wall Street Journal reported that Pfizer (PFE.N) was in early talks to acquire the biotech firm.

☆ Wall Street set for opening gains after sharp weekly losses
▼ + stars: | 2023-02-27 | by ( Sruthi Shankar | ) www.reuters.com time to read: +3 min

Futures pointed to a recovery in sentiment on Monday as U.S. Treasury yields slipped after a strong rally. Rate-sensitive growth stocks such as Apple Inc (AAPL.O) and Amazon.com Inc (AMZN.O) climbed in premarket trading. So investors are concluding from a seasonal perspective that maybe stocks could rally at least in the near term." After last week's hawkish comments from the Fed policymakers, investors will turn to Fed Governor Philip Jefferson's speech later in the day. Seagen Inc (SGEN.O) surged 13.2% after the Wall Street Journal reported that Pfizer (PFE.N) was in early talks to acquire the biotech firm.

☆ Futures rise after Wall Street's worst weekly rout of 2023
▼ + stars: | 2023-02-27 | by ( ) www.reuters.com time to read: +2 min

SummarySummary Companies Futures up: Dow 0.41%, S&P 0.46%, Nasdaq 0.53%Feb 27 (Reuters) - Futures tracking the main U.S. indexes rose on Monday after Wall Street posted its worst weekly performance of 2023 on fears that the Federal Reserve would keep raising rates this year. Futures pointed to a slight recovery in market sentiment on Monday as some of the rate-sensitive growth stocks rose in premarket trading. ET, Dow e-minis were up 135 points, or 0.41%, S&P 500 e-minis were up 18.25 points, or 0.46%, and Nasdaq 100 e-minis were up 64 points, or 0.53%. Seagen Inc (SGEN.O) surged 14.9% after the Wall Street Journal reported that Pfizer (PFE.N) was in early talks to acquire the biotech firm. Reporting by Sruthi Shankar in Bengaluru; Editing by Saumyadeb ChakrabartyOur Standards: The Thomson Reuters Trust Principles.

☆ Jim Cramer's top 10 things to watch in the stock market Monday: Bouncing stocks, Club earnings ahead, inflation signs
▼ + stars: | 2023-02-27 | by ( Jim Cramer | ) www.cnbc.com time to read: +4 min

My top 10 things to watch Monday, Feb. 27 1. One of the things we talked about was the first thing you must do before you buy a single stock. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade.

☆ Shionogi sees COVID pill reaping $2 billion in annual sales upon U.S. approval
▼ + stars: | 2023-02-27 | by ( Rocky Swift | ) www.reuters.com time to read: +3 min

Xocova, a protease inhibitor like the COVID treatments developed by Pfizer Inc (PFE.N) and Merck & Co (MRK.N), was granted emergency approval by Japanese regulators in November, making it the nation's first domestically produced oral treatment for COVID. "If you kill the virus fast enough and sharp enough, the lower the probability of long COVID. According to one study by the Veterans Affairs St. Louis Health Care System, Pfizer's antiviral drug Paxlovid cuts the risk of developing many long COVID symptoms. Shionogi is hoping for Xocova sales of around $1 billion to $1.5 billion this year. "I have no regrets," Teshirogi said, adding that expectations among shareholders and the public had demanded that Shionogi devote its resources to fighting COVID.

☆ Pfizer in talks to buy Seagen for likely for more than $30 bln - WSJ
▼ + stars: | 2023-02-27 | by ( ) www.reuters.com time to read: 1 min

Feb 26 (Reuters) - Pfizer Inc (PFE.N) is in early talks to acquire drugmaker Seagen Inc (SGEN.O), the Wall Street Journal reported late on Sunday, citing people familiar with the matter. Seagen has a market value of some $30 billion and would be expected to command a premium over that, the report said, adding that the deal talks are in preliminary stages. Pfizer declined to comment on the report, while Seagen did not immediately respond to Reuters request for a comment. Seagen was in advanced talks last year to be acquired by Merck (MRK.N), in a deal that would have been worth $40 billion or more, the Journal reported at the time, but the two sides failed to reach agreement. Reporting by Rahat Sandhu in Bengaluru; Editing by Nivedita BhattacharjeeOur Standards: The Thomson Reuters Trust Principles.

☆ FDA says Guillain-Barre syndrome is possible risk of Pfizer's RSV vaccine for older adults
▼ + stars: | 2023-02-24 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in which the body's immune system mistakenly attacks the nerves. There was also a possible case of Guillain-Barre syndrome in GSK 's RSV vaccine trials, but the company said there was insufficient evidence to confirm a diagnosis. They will also vote Wednesday on GSK's RSV vaccine for older adults. The Guillain-Barre casesIn Pfizer's trial, a 66-year-old man in the U.S. with a history of hypertension developed Guillain-Barre symptoms seven days after vaccination. He was hospitalized again after suffering a fall and was subsequently diagnosed with Guillain-Barre Syndrome.

☆ Merck's COVID pill fails to prevent infection among household members
▼ + stars: | 2023-02-21 | by ( ) www.reuters.com time to read: +1 min

The results were similar to data from rival Pfizer Inc (PFE.N), whose COVID pill Paxlovid also failed to prevent infections among household contacts. Merck's late-stage trial enrolled over 1,500 participants, who were household contacts exposed to an individual with at least one symptom and had recently tested positive for COVID-19. Its Lagevrio pill, also known as molnupiravir, was given every 12 hours for five days and was compared with a placebo group. Participants treated with the pill were 23.6% less likely to develop COVID than those given a placebo through day 14, failing to meet the main goal of the trial, Merck said. Pfizer's Paxlovid and Merck's Lagevrio pills were given emergency use authorization in Dec. 2021 for patients with mild-to-moderate COVID that tested positive for the virus, and who were at risk of progressing to severe COVID.

☆ Cramer's lightning round: Pfizer is a buy in a market slowdown
▼ + stars: | 2023-02-21 | by ( Rebecca Picciotto | ) www.cnbc.com time to read: 1 min

In this article ZIWOOFASTSPIPFE Follow your favorite stocks CREATE FREE ACCOUNTStock Chart Icon Stock chart icon Impinj Inc. stock chartImpinj Inc. : "It is a great company. Stock Chart Icon Stock chart icon AST Spacemobile Inc. stock chartAST Spacemobile Inc. : "They're not making any money." Stock Chart Icon Stock chart icon Petco stock chartPetco : "It is at $10, which tells me, believe it or not, something's wrong. Stock Chart Icon Stock chart icon ZoomInfo Technologies Inc. stock chartZoomInfo Technologies Inc .: "Let's zoom out...I don't need another marketer." Stock Chart Icon Stock chart icon Pfizer Inc. stock chartPfizer Inc .: "If there is going to be a slow down, I want to buy Pfizer."

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