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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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Sobr Safe stock hits 52-week low at $0.09 amid market challenges

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In a turbulent market environment, Sobr Safe Inc. (SOBR) has experienced a significant downturn, with its stock price touching a 52-week low of $0.09. This latest price level reflects a stark contrast from its previous performance, marking a drastic 1-year change with a decline of -92.06%. Investors have been closely monitoring the company’s trajectory as it navigates through the prevailing economic headwinds that have impacted its market valuation. The steep drop in Sobr Safe’s stock price over the past year has raised concerns among stakeholders about the company’s future prospects and the broader implications for its industry segment.

In other recent news, SOBR Safe, Inc. has been focusing on its financial health and product expansion. The company launched a comprehensive campaign for its non-invasive alcohol detection technology, SOBRsafe™, targeting behavioral health providers. The initiative is expected to reach over 45,000 decision-makers and garner more than 4,000,000 views within a year.

SOBR Safe has also been granted an extension by the Nasdaq Hearings Panel to meet the Nasdaq’s listing requirements. The company, which was previously at risk of delisting, now has until October 23, 2024, to regain compliance with the minimum bid price and stockholders’ equity rules. As part of its efforts to improve its financial position, SOBR Safe secured approximately $2.8 million in gross proceeds through the full exercise of outstanding warrants and debt conversion, eliminating $2.6 million in debt.

In a recent Special Stockholder Meeting, shareholders approved the issuance of up to 20,638,326 shares of common stock upon the exercise of a warrant. This move allows the company to issue additional shares, potentially diluting current ownership percentages. Additionally, SOBR Safe expanded its product portfolio by selling its SOBRcheck and SOBRsure devices to Lake Erie Interlock, Inc., marking an expansion of their alcohol detection technology services in Ohio. These recent developments are part of SOBR Safe’s ongoing efforts to improve its financial health and continue its listing on the Nasdaq.

InvestingPro Insights

In light of Sobr Safe Inc.’s (SOBR) recent stock performance, a glance at the latest InvestingPro data and tips may offer investors additional context. Despite the stock’s considerable decline, with a one-year price total return of -91.18%, InvestingPro Tips suggest that analysts anticipate sales growth in the current year. This could indicate potential for a turnaround, despite the company’s challenges. Additionally, SOBR holds more cash than debt on its balance sheet, which may provide some financial stability in these uncertain times.

From a valuation perspective, Sobr Safe Inc. has a market capitalization of just $3.31 million, with a Price/Book ratio as of Q2 2024 at 0.95, possibly signaling that the stock is trading close to its net asset value. Moreover, the company has seen revenue growth of 47.72% over the last twelve months as of Q2 2024, which could be a positive sign for investors looking for growth potential in small-cap companies.

For those seeking more detailed analysis, there are additional InvestingPro Tips available, offering deeper insights into Sobr Safe’s financial health and market position. To explore these further, investors can visit https://www.investing.com/pro/SOBR for a comprehensive set of tips and metrics.

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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Germany to hold onto Commerzbank stake as lender aims for independence

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By Tom Sims and Christian Kraemer

FRANKFURT (Reuters) -Germany will not sell any more shares in Commerzbank (ETR:) for now and the bank’s strategy is “geared towards independence,” the country’s Finance Agency said on Friday, in the clearest sign yet that the government doesn’t currently favour a takeover of the nation’s No. 2 lender.

The statement comes days after Italian bank UniCredit announced it had swooped in to buy a 9% stake in Commerzbank to become its second largest shareholder, and its Chief Executive Andrea Orcel signalled his merger ambitions.

But UniCredit’s move – a deal codenamed ‘Flash’ after Orcel’s dog – took Berlin by surprise and triggered opposition from labour unions and a defence strategy from Commerzbank.

The German government, which still owns 12% of Commerzbank after selling 4.5% of its shares to UniCredit, would play a key role in whether any deal can take place.

However, over the past week labour unions and Commerzbank management have called on the government to hold off on any further share sales.

The Finance Agency, which is part of the German finance ministry and manages government holdings, said a committee meeting of government officials on Friday had decided it “will not, until further notice, sell any additional shares”.

UniCredit declined to comment. A Commerzbank spokesperson said the bank had a strategy that works.

“Commerzbank is a stable and profitable institute. The bank’s strategy is geared towards independence. The Federal government will accompany this until further notice by maintaining its shareholding,” the agency said.

An official from Germany’s finance ministry, who did not wish to be identified, on Friday described the recent sale of part of Commerzbank’s stake as a test to see whether there were strategic buyers in the market. But others in the government have said they had wanted the shares that all went to UniCredit to go to a broad base of investors.

STRONGER COMPETITOR

UniCredit CEO Orcel has said he wants to start talks on a merger he says would “create a much stronger competitor” in Germany. His gambit comes after years of calls for Europe to improve its banks’ competitiveness in the face of larger U.S. and Asian rivals. 

He faces big hurdles.

Cross-border European banking deals have been stymied by factors including years of paltry profitability that have left lenders too weak to try for tie-ups. And regulatory barriers to moving resources freely across borders have been reinforced by politicians’ preference for home-grown ‘champions’.   

A turnaround of UniCredit has overcome one of the obstacles. The bank, unlike rivals, has the financial firepower for a bold combination after reaping bumper profits.

But national politics will be the hard part, and some investors have cautioned that cross-border deals remain difficult.

Anke Reingen, a banking analyst at RBC, said UniCredit was now unlikely to make a takeover offer soon.

© Reuters. FILE PHOTO: A sign for an ATM of Commerzbank is seen next to the headquarters of Deutsche Bank (R) in Frankfurt, Germany, March 19, 2019.  REUTERS/Kai Pfaffenbach/File Photo

“We do not think a deal is off the table, forever, but any move is likely to be later than we had initially expected,” she said.

Friday’s announcement means the German government’s plan is to now hold its Commerzbank shares beyond the 90-day lockup agreed at the time of the share sale last week, according to a person familiar with the discussions.

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US nuclear regulator has not gotten application for Three Mile Island restart

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By Timothy Gardner and Laila Kearney

WASHINGTON (Reuters) – The U.S. Nuclear Regulatory Commission (NRC) said on Friday it has not yet gotten an application from Constellation Energy on restarting the Three Mile Island nuclear reactor.

Constellation and Microsoft (NASDAQ:) have signed a data center deal to help resurrect a reactor by 2028 at Three Mile Island in Pennsylvania. It has been shut since 2019.

“At this point there’s nothing in front of us in terms of an application. It’s up to Constellation to lay out its rationale for justifying restart, so we’re prepared to engage with the company on next steps,” said NRC spokesperson Scott Burnell.

Constellation said it had plans to file a permit application but did not immediately specify a timeline for doing so. “We anticipate the NRC review to be complete in 2027,” a company spokesperson said.

© Reuters. FILE PHOTO: The Three Mile Island Nuclear power plant is pictured from Royalton, Pennsylvania, U.S. May 30, 2017.   REUTERS/Carlo Allegri/File Photo

Nuclear proponents complain that NRC takes too long to review licenses, and a law signed by President Joe Biden this year is meant to help address that. But as demand for power soars for the first time in decades, the NRC is mulling a host of applications from new high-tech nuclear reactors and an application from a decommissioned reactor, in Michigan called Palisades, which if approved could be the first U.S. reactor to come back from restart.

Burnell said the NRC will use existing review processes to consider any licenses for TMI. Some opponents of quickly reopening shuttered nuclear plants have filed a petition at NRC saying the agency should adopt a new rule-making for such cases, as no closed U.S. nuclear power plant has ever been resurrected.

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