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☆ Moderna Shows Progress Toward Cancer Vaccines
▼ + stars: | 2023-04-16 | by ( Brianna Abbott | ) www.wsj.com time to read: 1 min

A trial offers some of the strongest evidence yet that vaccines such as Moderna’s could benefit cancer patients. Moderna Inc.’s cancer vaccine helped prevent relapse for melanoma patients, results from a midstage trial showed, demonstrating progress in the pursuit of shots to ward off cancer by jump-starting the immune system. About 79% of high-risk melanoma patients who got Moderna’s personalized vaccine and Merck & Co.’s immunotherapy Keytruda were alive and cancer-free at 18 months, compared with about 62% of patients who received immunotherapy alone, researchers said Sunday. The 157-person trial offers some of the strongest evidence yet that such vaccines could benefit cancer patients.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

☆ Moderna, Merck Show Progress Toward Cancer Vaccines
▼ + stars: | 2023-04-16 | by ( Brianna Abbott | ) www.wsj.com time to read: 1 min

A Moderna and Merck trial offers some of the strongest evidence yet of vaccines that could benefit cancer patients. Moderna Inc. and Merck & Co.’s cancer vaccine helped prevent relapse for melanoma patients, results from a midstage trial showed, demonstrating progress in the pursuit of shots to ward off cancer by jump-starting the immune system. About 79% of high-risk melanoma patients who got the personalized vaccine and Merck’s immunotherapy Keytruda were alive and cancer-free at 18 months, compared with about 62% of patients who received immunotherapy alone, researchers said Sunday. The 157-person trial offers some of the strongest evidence yet that such vaccines could benefit cancer patients.

☆ Catalent flags problems at its manufacturing plants; CFO departs
▼ + stars: | 2023-04-14 | by ( ) www.reuters.com time to read: +1 min

The company's clients have included COVID-19 vaccine makers such as Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N). Catalent said it experienced "productivity issues" at its gene therapy manufacturing site in Harmans, Maryland, and faced similar issues at its drug product and drug substance manufacturing facilities in Bloomington, Indiana and Brussels, Belgium. The issues would impact financial results for the third quarter and Catalent's forecast for the remainder of fiscal 2023, the company said. Catalent named company insider Ricky Hopson as interim CFO and said it had launched the search for a permanent finance chief. The company's shares were trading at $50.77 before the bell.

☆ 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.

☆ Wall St ends mixed as inflation data comes into focus
▼ + stars: | 2023-04-11 | by ( Stephen Culp | ) www.reuters.com time to read: +4 min

The bellwether S&P 500 ended essentially unchanged. "With huge inflation data tomorrow, Fed minutes coming out soon and earnings right around the corner, traders are taking a wait and see approach to see how the inflation data comes in." Analysts expect aggregate first-quarter S&P 500 earnings falling 5.2% year-on-year, a stark reversal from the 1.4% annual growth seen at the beginning of the quarter. Among the 11 major sectors of the S&P 500, communication services (.SPLRCL) and tech (.SPLRCT) ended in the red, while energy (.SPNY) and financials (.SPSY) enjoyed the largest percentage gains. The S&P 500 posted nine new 52-week highs and no new lows; the Nasdaq Composite recorded 64 new highs and 118 new lows.

☆ S&P 500 edges higher as investors look to CPI
▼ + stars: | 2023-04-11 | by ( Stephen Culp | ) www.reuters.com time to read: +4 min

With a lack of market moving catalysts, investors looked ahead to Wednesday's consumer price index (CPI) for any evidence that the long, slow inflation cooldown continues. Beyond CPI, investors are eyeing first-quarter reporting season, which surges from the starting gate this Friday with results from three major banks, Citigroup Inc (C.N), JPMorgan Chase & Co (JPM.N) and Wells Fargo & Co (WFC.N). Analysts expect aggregate first-quarter S&P 500 earnings falling 5.2% year-on-year, a stark reversal from the 1.4% annual growth seen at the beginning of the quarter. Among the 11 major sectors of the S&P 500, energy (.SPNY) and materials (.SPLRCM) were enjoying the biggest percentage gains, while communication services (.SPLRCL) and tech (.SPLRCT) were in the red. The S&P 500 posted eight new 52-week highs and no new lows; the Nasdaq Composite recorded 56 new highs and 86 new lows.

April 11 (Reuters) - A U.S. appeals court handed Moderna Inc (MRNA.O) a win on Tuesday, affirming a decision to cancel an Arbutus Biopharma Corp (ABUS.O) patent related to the companies' legal fight over Moderna's blockbuster COVID-19 vaccines. The U.S. Court of Appeals for the Federal Circuit upheld a U.S. Patent and Trademark Office tribunal's ruling that the patent for Arbutus' lipid nanoparticle (LNP) technology was invalid based on an earlier Arbutus patent that disclosed the same invention. Moderna challenged the patent at the PTO's Patent Trial and Appeal Board in 2018, and the board invalidated it in 2019. Arbutus separately sued Pfizer and BioNTech for patent infringement last week over their COVID-19 shots, in a lawsuit that also does not include the canceled patent. The Federal Circuit case is Arbutus Biopharma Corp v. ModernaTX Inc, U.S. Court of Appeals for the Federal Circuit, No.

Hopes that the Fed will soon end its aggressive monetary policy tightening campaign spurred a rebound in the S&P 500 this month after the collapse of two U.S. mid-sized lenders sparked a selloff in March. Analysts expect first-quarter profits at S&P 500 companies to fall 5.2% year-on-year, the worst contraction since the third quarter of 2020 and a stark reversal from the 1.4% annual growth forecast at the beginning of the year, according to Refinitiv IBES data. Remarks later on Tuesday from voting members of the Fed's rate-setting committee will be parsed for more clues on the central bank's policy moves. Seven of the 11 major S&P sectors rose, with gains in material (.SPLRCM) and energy (.SPNY) shares offsetting losses in technology (.SPLRCT) stocks. The S&P index recorded six new 52-week highs and no new lows, while the Nasdaq recorded 43 new highs and 72 new lows.

☆ Moderna to keep testing flu shot as it fails to meet 'early success' criteria
▼ + stars: | 2023-04-11 | by ( ) www.reuters.com time to read: +1 min

Companies Moderna Inc FollowApril 11 (Reuters) - Moderna Inc (MRNA.O) said on Tuesday it had not enrolled enough cases in a late-stage trial of its experimental flu vaccine to determine if the shot was successful or not, sending the company's shares down 8% in premarket trading. The company said, ahead of its annual vaccines conference, that it will continue testing the flu shot for efficacy. Moderna also forecast sales from its respiratory vaccines to be between $8 billion and $15 billion in 2027. It is testing vaccines against respiratory syncytial virus (RSV), influenza and a next-generation COVID-19 shot in late-stage studies. Reporting by Bhanvi Satija and Aditya Samal in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

Losses in megacap stocks such as Microsoft Corp (MSFT.O) and Amazon.com Inc (AMZN.O) weighed on the tech-heavy Nasdaq, while gains in industrial stocks such as Caterpillar Inc (CAT.N) boosted the Dow. Hopes that the Fed will soon end its aggressive monetary policy tightening helped the S&P 500 stabilize so far in April after the collapse of two U.S. mid-sized lenders sparked a selloff last month. Analysts expect first-quarter profits at S&P 500 companies to fall 5.2% year-on-year, a stark reversal from the 1.4% annual growth expected at the beginning of the year, according to Refinitiv data. Seven of the 11 major S&P sectors rose, with gains in industrial (.SPLRCI) and material (.SPLRCM) shares offsetting losses in technology (.SPLRCT) stocks. The S&P index recorded three new 52-week highs and no new low, while the Nasdaq recorded 32 new highs and 30 new lows.

☆ RSV cases in US show signs of return to pre-pandemic seasonality - CDC
▼ + stars: | 2023-04-06 | by ( ) www.reuters.com time to read: +2 min

April 6 (Reuters) - Respiratory syncytial virus (RSV) circulation is showing signs of return to pre-pandemic seasonality in the U.S. after two years of irregular onsets and peaks, the Centers for Disease Control and Prevention (CDC) said on Thursday. Typically, cases of RSV virus that can cause severe illness or death in the very young and old rose in October before waning in April. The varying timing could be challenging for drugmakers racing to get their RSV vaccines to the market. In both pre-pandemic and pandemic periods, RSV cases began to surge earlier in Florida and the Southeast and later in regions further north and west, the researchers said. "Policy makers should consider RSV seasonality when making recommendations about the timing of studies and administration of new immunization and other RSV prevention products," the report said.

☆ Moderna to Price Its Covid-19 Vaccine at $130 a Dose
▼ + stars: | 2023-03-22 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

The list price of Moderna’s Covid-19 vaccine is much higher than what the U.S. government has been paying. Moderna Inc. will price its Covid-19 vaccine at about $130 per dose when it shifts to commercial distribution of the shots later this year, much higher than what the federal government has paid. The plans could add to criticism of the company from lawmakers who are scheduled to explore the cost of the shots at a hearing Wednesday.

[1/3] CEO of Moderna Stephane Bancel looks up at the session "State of the Pandemic" during the World Economic Forum (WEF) in Davos, Switzerland, January 18, 2023. Moderna (MRNA.O) CEO Stephane Bancel was called to testify after the company flagged plans to raise the vaccine's price to as much as $130 per dose, drawing the ire of Democratic U.S. Senator Bernie Sanders, who chairs the influential Committee on Health, Education, Labor and Pensions (HELP). The government in May plans to end the COVID public health emergency, putting much of the vaccine purchasing in the hands of the private sector. Moderna in February forecast $5 billion in COVID vaccine sales this year, far less than the $18.4 billion windfall in 2022, due to decreasing demand for the shots.

☆ Moderna expects to price its COVID vaccine at about $130 in the US
▼ + stars: | 2023-03-21 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

REUTERS/Hannah BeierMarch 20 (Reuters) - Moderna Inc (MRNA.O) expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. Hoge said the government's Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. Sanders, chair of the Senate’s powerful Health, Education, Labor and Pensions Committee, has said Moderna should not raise the price of its vaccine because of the government funding it received. He plans to question Moderna Chief Executive Stephane Bancel on the price increase at the hearing on Wednesday. Moderna in February forecast significantly declining 2023 COVID-19 vaccine sales, which reached $18.4 billion in 2022.

☆ Vaccine makers prep bird flu shot for humans 'just in case'; rich nations lock in supplies
▼ + stars: | 2023-03-20 | by ( Jennifer Rigby | Thomson Reuters | Jen Reports On Health Issues Affecting People Around The World | ) www.reuters.com time to read: +5 min

There has also been a push among companies to develop a bird flu vaccine for poultry, a market potentially far larger than that for humans. Many countries' pandemic plans say flu shots should go first to the most vulnerable while supply is limited. The agreements include six of the largest seasonal flu manufacturers, such as GSK, Sanofi and CSL Seqirus, the WHO said. NEW APPROACHESIn a pandemic, vaccine manufacturers would shift production of seasonal flu vaccines and instead make shots tailored to the new outbreak when needed. The results will be closely watched, as the data on Moderna’s seasonal flu candidate was mixed.

☆ Moderna to hire around 2,000 employees amid mRNA development push
▼ + stars: | 2023-03-10 | by ( ) www.reuters.com time to read: +1 min

Companies Moderna Inc FollowMarch 10 (Reuters) - Moderna Inc (MRNA.O) said on Friday it was planning to hire about 2,000 employees globally by 2023-end and set up new offices on the U.S. West Coast, as it aims to scale up development of new products amid declining COVID vaccine sales. The COVID vaccine maker said it will open new offices in California and Seattle, adding that its Genomics unit will expand to south San Francisco. Last month, Moderna forecast rising costs for 2023 and a decline in COVID vaccine sales, raising concerns that the company could post a loss this year. The firm had about 3,900 full-time employees as of Dec. 31, according to a regulatory filing. Reporting by Raghav Mahobe in Bengaluru; Editing by Anil D'Silva, Shinjini Ganguli and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ Big Companies Seeing Tax Benefits From Law Change Some of Them Fought
▼ + stars: | 2023-03-08 | by ( Richard Rubin | Jennifer Williams-Alvarez | ) www.wsj.com time to read: +6 min

Those companies now qualify for a bigger tax break for exports because of the way the research-deduction change alters their tax calculations. Photo: Dado Ruvic/REUTERSModerna saw that tax break jump to a 7.4 percentage-point benefit on its tax rate from 4.8 points in 2021, even as its cash tax payments rose. The change requiring companies to spread out research deductions was part of the 2017 tax law, and it was designed to partly offset the revenue loss from cutting corporate tax rates. PREVIEWAt the same time, the smaller research deduction means many companies can get a bigger advantage from the export tax break. The size of the FDII tax break is based in part on how much income a company has.

☆ Moderna CEO Defends Pricing Plans for Covid-19 Shot
▼ + stars: | 2023-03-06 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Moderna Inc. Chief Executive Stéphane Bancel pushed back against criticism of the company’s pricing plans for its Covid-19 vaccine at Monday’s Wall Street Journal Health Forum. U.S. politicians including Sens. Bernie Sanders (I., Vt.), Elizabeth Warren (D., Mass.) and Peter Welch (D., Vt.) have questioned the company’s strategy around commercial pricing, which could be unveiled in the coming months. Moderna received funding from the U.S. government related to development of its Covid-19 vaccine.

☆ Moderna CEO Defends Pricing Plans for Covid Shot
▼ + stars: | 2023-03-06 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Moderna CEO Stéphane Bancel, said public funding sped the vaccine’s development. Moderna Inc. Chief Executive Stéphane Bancel pushed back against criticism of the company’s pricing plans for its Covid-19 vaccine at Monday’s Wall Street Journal Health Forum. Bernie Sanders (I., Vt.), Elizabeth Warren (D., Mass.) and Peter Welch (D., Vt.) have questioned the company’s strategy around commercial pricing, which could be unveiled in the coming months. Moderna received funding from the U.S. government related to development of its Covid-19 vaccine.

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.

☆ 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.

☆ Moderna to make milestone payments to NIH for COVID vaccine
▼ + stars: | 2023-02-24 | by ( ) www.reuters.com time to read: 1 min

Companies Moderna Inc FollowFeb 24 (Reuters) - Moderna Inc (MRNA.O) will make certain contingent development, commercial and regulatory milestone payments to the U.S. National Institutes of Health (NIH) related to the development of COVID-19 vaccines, the company said in a filing on Friday. Moderna and the U.S. government agency had entered into a license agreement in December related to certain patents concerning the COVID vaccine products, the filing showed. The vaccine maker first disclosed the deal in its fourth-quarter earnings release stating it missed profit estimates hurt by the royalty payment to NIH. Moderna said under the agreement it would pay low single-digit royalties on future net sales and also minimum annual royalties. Reporting by Khushi Mandowara in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna’s Earnings, Revenue Fall on Fewer Vaccine Sales
▼ + stars: | 2023-02-23 | by ( Dean Seal | ) www.wsj.com time to read: 1 min

Photo: Simon Simard for The Wall Street JournalModerna said its research and development expenses soared in the fourth quarter. Moderna Inc. reported lower revenue and earnings in the fourth quarter as demand for its Covid-19 vaccine sank from year-earlier highs when the spread of the Omicron variant boosted sales. The pharmaceutical company, based in Cambridge, Mass., on Thursday said a decrease in volumes for its Covid-19 vaccine pushed sales 29% lower to $5.1 billion, which still topped analyst expectations for $5.02 billion, according to FactSet.

☆ Moderna reaffirms 2023 COVID vaccine sales forecast of $5 billion
▼ + stars: | 2023-02-23 | by ( ) www.reuters.com time to read: 1 min

Companies Moderna Inc FollowFeb 23 (Reuters) - Moderna Inc (MRNA.O) reaffirmed its annual sales forecast of $5 billion for its COVID-19 vaccines, which was below market expectations as the company anticipated lower demand in the fourth year of the pandemic. Sales of the COVID vaccine, Moderna's sole commercial product, were widely expected to fall sharply this year from $18.4 billion in 2022. Moderna's forecast was lower than Refinitiv estimates of $6.98 billion. The company also reiterated its plans to file for regulatory approval its respiratory syncytial virus vaccine in the first half of 2023 as it looks to build its product portfolio beyond COVID vaccines. Reporting by Aditya Samal and Leroy Leo; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

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