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FDA approves Moderna’s updated COVID-19 vaccine

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CAMBRIDGE, MA – The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Moderna , Inc.’s (NASDAQ:) updated COVID-19 vaccine, Spikevax® (2024-2025 formula), for individuals aged 12 and older. In addition, an Emergency Use Authorization (EUA) has been granted for the vaccine’s use in children from 6 months to 11 years old.

Moderna’s latest vaccine formulation targets the KP.2 variant of SARS-CoV-2, aiming to prevent COVID-19 across all age groups starting from 6 months. Following the FDA’s approval, the company expects the vaccine to be available in pharmacies and care settings across the U.S. shortly.

The approval is grounded on a combination of data including manufacturing, preclinical studies, and previously gathered clinical and real-world evidence which supports the safety and efficacy of Moderna’s mRNA COVID-19 vaccines. The decision to update the vaccine to a monovalent KP.2 composition follows the FDA’s guidance for the 2024-2025 COVID-19 vaccine composition.

Stéphane Bancel, CEO of Moderna, commented on the significance of vaccination amidst the ongoing health risks posed by COVID-19, which led to over 600,000 hospitalizations in the U.S. during the 2023-24 season. He also emphasized the importance of staying current with vaccinations to prevent severe illness.

Moderna’s COVID-19 vaccines have been generally well-tolerated, with the most common adverse events reported being pain at the injection site, headache, fatigue, myalgia, and chills.

The company is also manufacturing an updated vaccine targeting the JN.1 variant, as some countries have recommended a vaccine specific to this variant. Regulatory applications for Moderna’s updated vaccines targeting either the KP.2 or JN.1 variants are under review in other countries, with decisions expected in the coming weeks.

Moderna, a leader in mRNA medicine, has been at the forefront of developing vaccines and therapeutics for various diseases, including one of the earliest and most effective COVID-19 vaccines. Its mRNA platform has been instrumental in the rapid development of medical solutions.

The information in this article is based on a press release statement from Moderna, Inc.

In other recent news, Moderna’s financial performance has been the subject of several analyst revisions. Following a challenging second quarter, Deutsche Bank upgraded Moderna shares from Sell to Hold, citing a potential return to revenue growth and a more balanced risk-reward scenario. RBC Capital, however, downgraded Moderna’s shares from ‘Outperform’ to ‘Sector Perform’, expressing concerns about near-term challenges in the vaccine market. Piper Sandler maintained an Overweight rating on Moderna, despite reducing the price target, due to the company’s lowered sales guidance for the year.

Moderna’s earnings call revealed a net loss and a drop in COVID-19 vaccine sales outside the U.S. in the second quarter of 2024. The company revised its 2024 net product sales outlook to between $3.0 billion and $3.5 billion, attributing this adjustment to various market pressures and potential revenue deferrals. Despite these difficulties, Moderna reported positive Phase III results for its flu and COVID-19 combo vaccine and launched its RSV vaccine, mRESVIA, in the U.S.

These recent developments highlight the dynamic nature of Moderna’s operations amidst a competitive vaccine market. The company’s collaborations, such as the one with Merck for the development of mRNA-4157, a treatment combined with KEYTRUDA for a broad range of cancers, are progressing. Investors should consider these factors when evaluating the company’s prospects.

InvestingPro Insights

As Moderna, Inc. (NASDAQ:MRNA) garners FDA approval for its updated COVID-19 vaccine, Spikevax®, investors and stakeholders are closely monitoring the company’s financial health and market performance. According to InvestingPro data, Moderna currently holds a market capitalization of approximately $31.75 billion. The company’s Price to Earnings (P/E) ratio stands at -5.35, reflecting market sentiment about its future earnings potential. Moreover, the company’s Price to Book (P/B) ratio as of the last twelve months ending Q2 2024 is 2.7, which can offer insights into how the market values the company’s assets relative to its current share price.

Despite the approval of its vaccine, Moderna faces challenges as reflected in its revenue growth metrics. The company has experienced a significant decline in revenue growth of -52.6% over the last twelve months ending Q2 2024. This downturn is further highlighted by the quarterly revenue growth rate of -29.94% for Q2 2024. Additionally, an InvestingPro Tip points out that analysts anticipate a sales decline in the current year, which investors should consider when evaluating the company’s future prospects.

InvestingPro offers more insights into Moderna’s financials and market performance. Currently, there are 11 additional InvestingPro Tips available for Moderna, which can be accessed for more in-depth analysis. These tips include observations on the company’s cash position, profitability expectations, and stock price volatility. For instance, one InvestingPro Tip notes that Moderna holds more cash than debt on its balance sheet, which could be a sign of financial stability amidst the anticipated sales decline.

For a more comprehensive understanding of Moderna’s financial standing and to access the full range of InvestingPro Tips, interested parties can visit https://www.investing.com/pro/MRNA.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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14 lessons from 2024 to remember in 2025: BofA

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Investing.com — In a recent note, Bank of America outlined 14 key lessons from 2024 that investors should keep in mind as they head into 2025, warning that market momentum and stretched valuations could face headwinds in the year ahead.

While this year resembled the steady gains of 1996-97, rather than the bubble peaks of 1998-99, risks are mounting—from geopolitical tensions and rising debt to market fragility highlighted by the VIX.

BofA points to opportunities in Europe, China, and Japan but cautions that volatility, trade disputes, and macroeconomic uncertainty will shape the next leg of the market cycle.

Below are the 14 lessons that BofA highlighted.

1. 2024 was a strong year for markets, but it might only be the beginning.

2. The market’s performance in 2024 looked more like the steady gains of 1996-97 than the bubble peaks of 1998-99.

3. In a bubble environment, market leadership can persist for longer than investors can afford to stay underweight.

4. However, the combination of strong momentum and high valuations is already too stretched to avoid a potential bust.

5. The has shown that markets remain fragile, and a major shock may be overdue.

6. August 2024 suggests buying market dips and locking in volatility spikes; using smarter strategies like skewed delta positioning may be key for 2025.

7. Rising debt levels and persistent inflation mean bond vigilantes remain the most visible macroeconomic tail risk.

8. Market fragility, faster reactions, and elevated valuations suggest a repeat of the calm volatility seen in 2017 is unlikely.

9. A Trump election victory has reignited concerns around tariffs, with European companies favored by dollar strength potentially becoming the next trade targets.

10. European equities remain cheap and unloved—investors should be cautious about being caught short, as fewer crowded trades mean less volatility pain.

11. China’s outperformance over Japan in 2024 could continue if U.S. interest rates decline.

12. VIX options data indicates that positioning risks in the market have not gone away.

13. Eurozone bank dividends have outperformed the for much of the past year; investors may need to hedge against a different outcome in 2025.

14. The risk of sharp movements in the Japanese yen, driven by volatility, could cause instability for the in 2025.

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Class Action Lawsuit Reminder WOLF: Kessler Topaz Meltzer & Check, LLP Reminds Wolfspeed, Inc. (WOLF) Investors – A Securities Fraud Class Action Lawsuit Has Been Filed

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RADNOR, PA. – (NewMediaWire) – December 21, 2024 – The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed against Wolfspeed (NYSE:), Inc. (Wolfspeed) (NYSE: WOLF) on behalf of those who purchased or otherwise acquired Wolfspeed securities between August 16, 2023, and November 6, 2024, inclusive (the Class Period). The lead plaintiff deadline is January 17, 2025.

CONTACT KESSLER TOPAZ MELTZER & CHECK, LLP:

If you suffered Wolfspeed losses, you may CLICK HERE or go to: https://www.ktmc.com/new-cases/wolfspeed-inc?utm_source=PR&utm_medium=link&utm_campaign=wolf&mktm=r

You can also contact attorney Jonathan Naji, Esq. by calling (484) 270-1453 or by email at info@ktmc.com .

DEFENDANTS ALLEGED MISCONDUCT:

The complaint alleges that, throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) Wolfspeeds optimistic claims of potential growth of its Mohawk Valley fabrication facility and general demand for Wolfspeeds 200mm wafers in the electronic vehicle market fell short of reality; and (2) Wolfspeed had overstated demand for its key product and placed undue reliance on purported design wins while the Mohawk Valley facilitys growth had begun to taper before recognizing the $100 million revenue per quarter allegedly achievable with only 20% utilization of the fabrication, let alone the promised $2 billion revenue purportedly achievable by the facility.

Please CLICK HERE to view our video or copy and paste this link into your browser: https://youtu.be/zMLfnSRjg2Y

THE LEAD PLAINTIFF PROCESS:

Wolfspeed investors may, no later than January 17, 2025, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

Kessler Topaz Meltzer & Check, LLP encourages Wolfspeed investors who have suffered significant losses to contact the firm directly to acquire more information.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. The complaints in this action were not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com .

CONTACT:

Kessler Topaz Meltzer & Check, LLP

Jonathan Naji, Esq.

(484) 270-1453

280 King of Prussia Road

Radnor, PA 19087

info@ktmc.com

May be considered attorney advertising in certain jurisdictions. Past results do not guarantee future outcomes.

View the original release on www.newmediawire.com

Copyright 2024 JCN Newswire . All rights reserved.

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Starbucks workers’ union strikes across US as talks hit impasse

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By Savyata Mishra, Gursimran Mehar and Renee Hickman

(Reuters) -Some members of the Starbucks (NASDAQ:) workers’ union that represents more than 10,000 baristas walked off their jobs in multiple U.S. cities on Friday, citing unresolved issues over wages, staffing and schedules.

The five-day strike, which began on Friday and closed Starbucks cafes in Los Angeles, Chicago and Seattle, will expand to Columbus (WA:), Denver, and Pittsburgh through Saturday, the union said in a statement.

This is the latest in a series of labor actions that have picked up pace across service industries following a period when workers at manufacturers in the automotive, aerospace and rail industries won substantial concessions from employers.

At Starbucks, the Workers United union, which represents employees at 525 stores across the U.S., said late on Thursday that walkouts would escalate daily, and could reach “hundreds of stores” nationwide by Christmas Eve.

“It’s estimated that 10 stores out of 10,000 company-operated stores did not open today,” Starbucks said, adding that there was no significant impact to store operations on Friday.

Around 20 people joined a picket line at a Starbucks location on Chicago’s north side, buffeted by snow and wind, but cheering in response to the honking horns of passing cars.

A few confused customers tried to walk into the closed store before strikers began chanting, but union member Shep Searl said the reaction had been mostly positive.

Searl said 100% of the unionized workers at the Starbucks location in Chicago’s Edgewater neighborhood were participating in the strike, and according to the workers, they have been subject to numerous unfair labor practices including write-ups, “captive-audience” meetings and firings.

The union member said they made about $21 an hour and added, “that would have been a great wage in 2013”.

It is an inadequate wage, the baristas said, given inflation and the high cost of living in a large city, especially since they rarely get 40-hour work weeks.

WORKERS SNUB OFFER

Negotiations between the company and Workers United began in April, based on an established framework agreed upon in February, which could also help resolve numerous pending legal disputes.

The company said on Thursday it has held more than nine bargaining sessions with the union since April, and reached more than 30 agreements on “hundreds of topics”, including economic issues.

The Seattle-headquartered firm said it is ready to continue negotiations, claiming the union delegates prematurely ended the bargaining session this week.

The union, however, said in a Facebook (NASDAQ:) post on Friday that Starbucks had yet to present a serious economic proposal with less than two weeks remaining until the year-end contract deadline.

The workers’ group also snubbed an offer of no immediate wage hike and a guarantee of a 1.5% increase in future years.

“Workers United proposals call for an immediate increase in the minimum wage of hourly partners by 64%, and by 77% over the life of a three-year contract. This is not sustainable,” Starbucks said on Friday.

In response to Starbucks’ statement on the proposals, Michelle Eisen, a Starbucks barista and bargaining delegate, said, “Starbucks’ characterization of our proposals is misleading and they know it. We are ready to finalize a framework that includes new investments in baristas in the first year of contracts”.

Separately, the baristas’ union said on Friday that it filed a new labor practice charge against the coffee house, alleging Starbucks “refused to bargain and engaged in bad faith bargaining” over economic issues.

Hundreds of complaints have been filed with the National Labor Relations Board (NLRB), accusing Starbucks of unlawful labor practices such as firing union supporters and closing stores during labor campaigns. Starbucks has denied wrongdoing and said it respects the right of workers to choose whether to unionize.

WORKING ON A TURNAROUND

Last month, the NLRB said that Starbucks broke the law by telling workers at its flagship Seattle cafe that they would lose benefits if they joined a union.

“It’s (the strike) taking place during one of the busiest times of the year for Starbucks, which could magnify its impact while bringing unwanted public scrutiny into the company’s labor practices,” Emarketer analyst Rachel Wolff said.

The coffee chain is working on a turnaround under its newly appointed top boss, Brian Niccol, who aims to restore “coffee house culture” by overhauling cafes and simplifying its menu among other measures.

“Given how much Starbucks is already struggling to win over customers, it can ill afford any negative publicity – or impact to sales – that the strike could bring,” Wolff said.

© Reuters. Baristas picket in front of a Starbucks in Burbank, California, U.S., December 20, 2024. REUTERS/Daniel Cole

The Starbucks workers’ strike comes in the same week as Amazon.com (NASDAQ:) workers at seven U.S. facilities walking off the job on Thursday, during the holiday shopping rush.

There were 33 work stoppages in 2023, the most since 2000, though far lower than in past decades, data from the U.S. Bureau of Labor Statistics showed.

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