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☆ F.D.A. Panel Advises Vaccine Makers to Aim at Only One Covid Variant
▼ + stars: | 2023-06-15 | by ( Christina Jewett | ) www.nytimes.com time to read: +2 min

The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines. It remains unclear whether or when the vaccine makers or the F.D.A.

Persons: ”, Peter Marks, Natalie Thornburg Organizations: Pfizer, Moderna, Centers for Disease Control, World Health Organization, Agency Locations: United States

☆ FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
▼ + stars: | 2023-06-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family. Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall. But it's unclear how many Americans will roll up their sleeves to take the updated shots later this year.

Persons: Melinda Wharton, Novavax, John Jacobs, Peter Marks, David Kaslow Organizations: . Food, Centers for Disease Control, Advisors, Pfizer, Moderna, National Center, FDA, CDC, Novavax, omicron Locations: U.S, Novavax

☆ Covid vaccine maker Novavax sees a pathway to survival – but it won’t be easy
▼ + stars: | 2023-06-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +10 min

Jakub Porzycki | NurPhoto | Getty ImagesNovavax has a clear message for Wall Street: The cash-strapped Covid vaccine maker sees a pathway to survival. The 36-year-old company will continue to rely on its protein-based Covid vaccine – its only commercially available product – for most of its revenue this year. Once the U.S. government's supply of free Covid vaccines runs out, all three companies will sell updated shots directly to health-care providers. A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. But Taylor emphasized that the plan will help Novavax refocus on its top priority: delivering an updated vaccine in the coming months.

Persons: Jakub Porzycki, Novavax, Covid, Cowen, Brendan Smith, John Jacobs, Smith, that's, Silvia Taylor, Taylor, Jefferies, Roger Song, Patrick Van Katwijk, Mayank Mamtani, let's, Mamtani, Let's, Song, Ding Genhou Organizations: NurPhoto, Getty, Pfizer, Moderna, CNBC, Food and Drug Administration, World Health Organization, FDA, Dutch Health Service Organization, Riley Securities, U.S, Centers for Disease Control, CDC, Reuters, Visual China Locations: Krakow, Poland, Maryland, U.S, The Hague, Netherlands, Moderna, Geneva, Hohhot, Inner Mongolia Autonomous Region, China

☆ Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says
▼ + stars: | 2023-06-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. That means all three companies will start selling their updated Covid shots directly to health-care providers. The FDA staff's decision comes weeks after an advisory group to the World Health Organization recommended that Covid booster shots target XBB variants. Scientists have said that XBB strains are some of the most immune-evasive subvariants to date. Last year's Covid boosters were bivalent, meaning they targeted the original strain of the virus and omicron variants BA.4 and BA.5.

Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, World Health Organization, Moderna's, Centers for Disease Control Locations: U.S

☆ Cramer's Lightning Round: Novavax is a no-go
▼ + stars: | 2023-05-31 | by ( Julie Coleman | ) www.cnbc.com time to read: +1 min

Stock Chart Icon Stock chart icon Jazz Pharmaceuticals' year-to-date stock performance. Stock Chart Icon Stock chart icon ON Semiconductor's year-to-date stock performance. Stock Chart Icon Stock chart icon Novavax's year-to-date stock performance. Stock Chart Icon Stock chart icon Golar LNG's year-to-date stock performance. Stock Chart Icon Stock chart icon Tyson Foods' year-to-date stock performance.

Persons: it's, I'd, You've, Golar, Tyson Organizations: Jazz Pharmaceuticals, Investing, ON, Golar, New Fortress Energy, Tyson Foods Locations: Moderna

☆ Lightning Round: Jim Cramer says 'absolutely not' on buying Tyson Foods
▼ + stars: | 2023-05-31 | by ( Jim Cramer | ) www.cnbc.com time to read: 1 min

In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailLightning Round: Jim Cramer says 'absolutely not' on buying Tyson Foods'Mad Money' host Jim Cramer weighs in on stocks including: Jazz Pharmaceuticals, ON Semiconductor, Novavax, Golar and Tyson Foods.

Persons: Jim Cramer Organizations: Tyson Foods, Jazz Pharmaceuticals, ON Semiconductor

☆ TipRanks reveals the top 10 health care sector analysts of the past decade
▼ + stars: | 2023-05-21 | by ( Tipranks.Com Staff | ) www.cnbc.com time to read: +5 min

TipRanks leveraged its Experts Center tool to recognize the ones with a high success rate. We also analyzed each stock recommendation made by health care sector analysts in the past decade. TipRanks' algorithms calculated the statistical significance of each rating, average return and the analysts' overall success rate. The buy recommendation generated a return of 397.9% from May 12, 2020 to May 12, 2021. Boris Peaker - TD CowenBoris Peaker has the 10th spot on the list, with a success rate of 47%.

☆ WHO recommends new COVID shots should target only XBB variants
▼ + stars: | 2023-05-18 | by ( ) www.reuters.com time to read: +2 min

May 18 (Reuters) - A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants. New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered. The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected. The bivalent booster shots developed and distributed last year targeted two different strains - the Omicron variant as well as the original virus. WHO's advisory group, which recommends if changes are needed to the composition of future COVID-19 shots, said currently approved vaccines should continue to be used in accordance with the agency's recommendations.

Investors will look for clues on whether inflation is continuing to ease following the Labor Department's consumer price index (CPI) report on Wednesday. Shares of PayPal Holdings (PYPL.O) dropped and pressured the benchmark S&P 500 after the company cut its margin forecast. Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., May 4, 2023. Under Armour Inc (UAA.N) fell 5.66% as the sports apparel maker forecast its annual sales and profit below street expectations. The S&P 500 posted 14 new 52-week highs and 14 new lows; the Nasdaq Composite recorded 77 new highs and 171 new lows.

Shares of PayPal Holdings (PYPL.O) dropped 12% and led declines on the benchmark S&P 500 index (.SPX) after the company cut its margin forecast. They were also among the top drags on the Nasdaq Composite index (.IXIC). Shares of other Apple suppliers including Qualcomm (QCOM.O), Broadcom (AVGO.O), Qorvo (QRVO.O) and Corning (GLW.N) fell between 1.2% to 2%. The action-packed week will see the release of the much-awaited inflation data on Wednesday. The S&P index recorded 13 new 52-week highs and 12 new lows, while the Nasdaq recorded 52 new highs and 130 new lows.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

☆ Novavax shares surge on COVID/flu shot data, job cuts
▼ + stars: | 2023-05-09 | by ( ) www.reuters.com time to read: +2 min

May 9 (Reuters) - Novavax (NVAX.O) on Tuesday announced plans to cut a fourth of its workforce and unveiled promising data for its COVID-flu combination vaccine, spurring hopes of a recovery for the cash-strapped biotech and sending its shares more than 50% higher. Novavax, whose coronavirus vaccine is its lone marketed product after 35 years in business, is now banking on its cost-control measures and a successful trial for its COVID/flu combination vaccine candidate to help it stay afloat. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots. The new data comes at a time when global regulators expect COVID vaccination campaigns to be conducted annually like flu inoculations. The biotech expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year.

Yields on U.S. short-dated Treasury bills , jumped sharply as investors sold off bonds, which mature as early as June. That weighed on shares of high-growth companies, including Apple Inc (AAPL.O) and Microsoft Corp (MSFT.O), which fell about 0.5% each. ET, Dow e-minis were down 82 points, or 0.24%, S&P 500 e-minis were down 15.25 points, or 0.37%, and Nasdaq 100 e-minis were down 73.25 points, or 0.55%. Chip-gear maker Skyworks Solutions Inc's (SWKS.O) shares tumbled 11.7% after forecasting current-quarter revenue and earnings below estimates. Shares of other Apple suppliers including Qualcomm (QCOM.O) and Qorvo (QRVO.O) fell 0.9% and 2.3%, respectively.

☆ Novavax lays off 25% of workforce, releases 2023 outlook
▼ + stars: | 2023-05-09 | by ( ) www.reuters.com time to read: +1 min

May 9 (Reuters) - Novavax (NVAX.O) said on Tuesday it will reduce its global workforce by 25% as the cash-strapped biotech pushes forward with its plans to slash expenses and navigate tepid demand for its COVID-19 vaccines. Separately, Novavax said its COVID/flu combination shot was safe and well-tolerated in a mid-stage study, sending shares of the company up 9% before the bell. For the first quarter, it reported a net loss of $293.9 million, compared with a year-ago profit of $203.4 million. The biotech expects the cost-cut plans to help reduce its annual research and commercial expenses by 20% to 25% from last year. The company had $637 million in cash and equivalents at the end of the quarter, compared with $1.3 billion as of Dec. 31.

☆ Novavax says it is axing 25% of its workforce to cut costs
▼ + stars: | 2023-05-09 | by ( Krystal Hur | ) edition.cnn.com time to read: +1 min

New York CNN —Novavax is laying off 25% of its workforce to slash expenses, the biotech company said Tuesday. Still, the Maryland-based company said it’s focused on updating its Covid vaccine for the fall vaccine season, citing a modified US government agreement for up to 1.5 million additional doses of its Covid vaccine for delivery this year. Novavax expects its broader cost reduction plan, which also includes measures to consolidate facilities and infrastructure, to cut costs by 40% to 50% compared to the previous fiscal year. The US public health emergency is set to end on May 11, meaning Americans could have to start paying out of pocket for Covid testing and treatment. Novavax is the latest company to reduce its headcount to cut costs as companies brace for a possible recession and scale back their workforce after pandemic-era hiring sprees.

☆ Novavax surges more than 25% after company unveils job cuts, positive vaccine data
▼ + stars: | 2023-05-09 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. The company's Covid vaccine is its lone marketed product after 35 years in business. The company reported R&D expenses of $258 million and SG&A expenses of $162 million last year. The company raced against Pfizer and Moderna to develop the first Covid vaccine early in the pandemic. Novavax's shot is the first Covid vaccine to use protein technology, a decades-old method for fighting viruses used in routine vaccinations against hepatitis B and shingles.

☆ Stocks making the biggest moves midday: Palantir, Novavax, Under Armour and more
▼ + stars: | 2023-05-09 | by ( Alex Harring | ) www.cnbc.com time to read: +6 min

Palantir – Palantir shares popped nearly 20% after the software company beat first-quarter estimates and said it anticipates full-year profitability. The firm also reaffirmed full-year revenue guidance and raised its full-year adjusted EBITDA expectations, while cutting 6% of its workforce. Under Armour — The apparel company slipped 5.3% after the company projected earnings per share and revenue to be short of Wall Street expectations for the full-year. Fisker — Shares shed 4.8% after the automotive company's first quarter earnings came in under Wall Street forecasts. Trex Company — Trex Company jumped 8.1% after the maker of wood-alternative decking and railing topped analysts' first-quarter expectations, and issued stronger-than-expected second-quarter revenue guidance.

Shares of PayPal Holdings (PYPL.O) dropped 10.5% and led declines on the benchmark S&P 500 index (.SPX) after the company cut its margin forecast. They were also among the top drags on the Nasdaq Composite index (.IXIC). Shares of other Apple suppliers including Qualcomm (QCOM.O), Broadcom (AVGO.O), Qorvo (QRVO.O) and Corning (GLW.N) fell between 0.9% to 2%. That weighed on shares of high-growth companies, including Apple Inc (AAPL.O) and Microsoft Corp (MSFT.O), which fell about 0.3% each. The S&P index recorded six new 52-week highs and 10 new lows, while the Nasdaq recorded 20 new highs and 54 new lows.

☆ As earnings season winds down, investors turn to Tuesday's debt ceiling meeting
▼ + stars: | 2023-05-06 | by ( Zev Fima | ) www.cnbc.com time to read: +12 min

With only a small fraction of the S & P 500 left to report quarterly earnings, investors are now turning their focus to another major hurdle for the markets and economy: the debt ceiling crisis. Earlier this week, we looked back to debt limit crisis of 2011 for potential lessons. The protracted fight ultimately ended in an agreement in early August of that year, but it was a choppy summertime ride for investors. Within the portfolio, Wynn Resorts will report Tuesday, after the closing bell, and Disney will report on Wednesday, after the closing bell. Estee Lauder (EL) and Emerson Electric (EMR) reported earnings before the opening bell.

☆ CDC eases certain Covid-19 vaccine requirements for international travelers to US
▼ + stars: | 2023-04-28 | by ( Brenda Goodman | ) edition.cnn.com time to read: +2 min

CNN —The US Centers for Disease Control and Prevention is still requiring international visitors boarding flights to the United States to be vaccinated against Covid-19, but it’s easing vaccine requirements for those travelers. International travelers boarding flights to the United States will now be considered fully vaccinated two weeks after getting a single dose of either the Pfizer or Moderna mRNA vaccine any time after August 16, 2022, when bivalent formulations first became available. Previously, foreign travelers entering the United States were considered fully vaccinated two weeks after the second dose of a vaccine that required two primary doses, or two weeks after a vaccine that only required a single shot, such as the Johnson & Johnson vaccine. A number of older, monovalent vaccine regimens also qualify a foreign visitor as fully vaccinated. As part of the update, the older monovalent mRNA Covid-19 vaccines are no longer recommended in the United States, and updated vaccines are recommended for everyone age 6 months and older.

LONDON, April 21 (Reuters) - African countries are lining up to approve a new vaccine for malaria, with 20 million doses available for them to buy this year, the shot’s manufacturer told Reuters. African countries that do not have extensive resources for drug regulation have previously relied on the U.N. agency to initially review new medicines. "We expect many more countries to come through," Mary Hamel, the WHO's malaria vaccine implementation head, told the expert meeting on Tuesday. “We are committed to making the R21 vaccine available to people who need it most,” Poonawalla said. FUNDING DOUBTSThe moves are a further sign that African countries want to exert their own pharmaceutical oversight after COVID-19 exposed inequity in vaccine supply.

☆ US CDC signs off on second Omicron-updated COVID booster for older adults
▼ + stars: | 2023-04-19 | by ( ) www.reuters.com time to read: +1 min

April 19 (Reuters) - Older people and those with weakened immune systems may get a second dose of Omicron-targeting COVID-19 vaccines, the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday. The agency's decision after its advisory committee's meeting aligns it with the U.S. Food and Drug Administration's authorization on Tuesday for a second dose of Omicron-updated booster for the specified high-risk population. Adults aged 65 years and older can take a second dose of the updated vaccine, the CDC said, while people who are immunocompromised can get additional doses. It also said the original COVID-19 vaccine will no longer be recommended for use in the United States. Monovalent COVID-19 vaccines from Novavax (NVAX.O) or Johnson & Johnson's (JNJ.N) Janssen were not affected by the changes made today, the agency said.

Short interest in Novavax increased more than 13% to 37.8 million shares, or about 45% of the total float, between March 15-31, according to data compiled by FactSet. Other biotech companies that saw growing short interest are Cassava Sciences , with a 10% increase, and Fate Therapeutics , which saw a 26% boost. Meanwhile, bluebird bio had a 29% increase in its short interest to 26% of float. Cinemark and AMC Entertainment both saw increases in their short position to 28% and 27% of their respective floats. All names trade on the NYSE or Nasdaq, have short positions amounting to at least 25% of their total float and have market values of at least $100 million.

☆ Novavax cut $50 million in costs, plans to slash more, CEO says
▼ + stars: | 2023-04-12 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

April 12 (Reuters) - Novavax Inc (NVAX.O) cut about $50 million in costs in the first quarter of 2023 and plans to slash more, Chief Executive John Jacobs said in an interview on Wednesday. “We’re looking at everything from buildings, leases, land, headcount, and contractors, every aspect of our company and the way we work,” he told Reuters. Jacobs said Novavax would seek funding for its COVID/influenza combination shot, including a potential partnership, depending on whether the upcoming data is positive. The CEO added that the company did not expect to launch its individual flu vaccine this year, and will focus on the COVID vaccine. Global regulators expect vaccination campaigns to be conducted once a year, similar to annual flu inoculations.

☆ The Government’s Covid Casualties
▼ + stars: | 2023-03-07 | by ( The Editorial Board | ) www.wsj.com time to read: 1 min

Pharmaceutical development is intrinsically risky, but all too often companies succeed or fail owing to the whims of government. Consider the travails of Covid vaccine maker Novavax and the testing start-up Lucira Health . Novavax warned investors last week that it may not be able to stay in business. The Covid vaccine was Novavax’s first and only commercial product in its 36-year history. Although succeeding in clinical trials, the vaccine has been a commercial flop owing to regulatory delays and manufacturing hiccups.

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