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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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Consumers Energy Expanding Community Solar Program with 30-Acre Solar Project in Jackson County

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JACKSON, Mich., Sept. 19, 2024 /PRNewswire/ — Consumers Energy plans to break ground next spring on Blackman Solar, a new 30-acre community solar array in its home Jackson County that will provide local clean energy to customers through its Solar Gardens program.

Consumers Energy this week received approval from Blackman Township for the community solar project, which is slated to start generating electricity by the end of 2025.

“Blackman Solar is a great example of a partnership with a community to develop a project that delivers reliable, clean energy as well as local tax and economic benefits,” said David Hicks. Consumers Energy’s vice president of renewable energy development. “We’re grateful for the reception we’ve received from Blackman Township leaders and are excited to continue developing solar projects like this on our path to a carbon-neutral electric grid.”

Blackman Solar will generate power for Consumers Energy’s Solar Gardens community solar program, in which customers choose to support new solar projects without having to own solar arrays.

The new community solar facility will be the fourth that Consumers Energy owns and operates, joining other Solar Gardens projects in Cadillac, at Western Michigan University and at Grand Valley State University. Blackman Solar will include nearly 5,000 solar panels and will generate up to 2.5 megawatts of renewable electricity for 2,500 future Solar Gardens customers.

Blackman Solar also will provide new capacity to expand Consumers Energy’s income-qualified Solar Gardens program MI Sunrise. MI Sunrise is an efficient, easy, cost-effective way for municipalities, nonprofits and tribal governments to deploy federal grant dollars, providing access to clean, reliable renewable energy and measurable financial benefits to offset energy bills.

“Blackman Solar will help meet increased demand for community solar and offers shared solar infrastructure, accessibility and inclusivity, as well as financial and environmental benefits for all customers,” Hicks said.

Consumers Energy is committed to Michigan’s clean energy future. The energy provider is closing its final three coal-burning units next summer, one of the nation’s most aggressive timetables. The company is developing solar projects as part of its Clean Energy Plan to be carbon-neutral by 2040.

Consumers Energy is Michigan’s largest energy provider, providing and/or electricity to 6.8 million of the state’s 10 million residents in all 68 Lower Peninsula counties. Consumers Energy’s Clean Energy Plan calls for eliminating coal as an energy source in 2025, achieving net-zero carbon emissions and meeting 90% of customers’ energy needs through clean sources, including wind and solar.

For more information about Consumers Energy, go to ConsumersEnergy.com.

Check out Consumers Energy on Social Media

Facebook (NASDAQ:): https://www.facebook.com/consumersenergymichigan
Twitter: https://twitter.com/consumersenergy
LinkedIn: https://linkedin.com/company/consumersenergy
Instagram: https://www.instagram.com/consumersenergy

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First Horizon Is Now the Official Bank of the Ragin’ Cajuns

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MEMPHIS, Tenn., Sept. 19, 2024 /PRNewswire/ — First Horizon (NYSE:) Corp. (NYSE: FHN or “First Horizon“) is proud to announce that First Horizon Bank is now the Official Bank of the  University of Louisiana at Lafayette  Ragin’ Cajuns.

This five-year agreement expands First Horizon’s long-term commitment to the University  and includes a Ragin’ Cajun Visa (NYSE:) Debit card, prominent in-venue signage, entertainment and hospitality opportunities along with participation in game day fan activations and experiences, including the new Cajun Village.

“This is an exciting time to expand our partnership with ULL and ULL athletics,” said Jerry Prejean, President of Acadiana for First Horizon. “With more than $2.5 million invested in recent years towards academic and athletic excellence, First Horizon is proud to deepen our relationship with the University and work together as two long-standing community leaders dedicated to making Acadiana a great place to call home.”

“As opportunities have grown for businesses to support Ragin’ Cajuns athletics, First Horizon Bank has been right there growing with us every step of the way,” adds Brian Bille, General Manager of LEARFIELD-based Ragin’ Cajuns Sports Properties. “Jerry’s commitment to our community has never wavered, and I’m excited to help First Horizon build affinity with our fans through this enhanced partnership, and encourage our fans to add the all-new Ragin’ Cajuns branded debit card to their wallet.”

About First Horizon  
First Horizon Corp. (NYSE: FHN), with $82.2 billion in assets as of June  30, 2024, is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel. Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon has been recognized as one of the nation’s best employers by Fortune and Forbes magazines and a Top 10 Most Reputable U.S. Bank. More information is available at  www.FirstHorizon.com.

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Oil prices rise on easing demand worries after jumbo Fed rate cut

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Investing.com — Oil prices jumped Thursday, riding on a wave of risk-on sentiment as the Federal Reserve’s outsized interest rate cut on Wednesday eased worries that a slowing US economy would further dent crude demand.

At 2:06 p.m. ET (1906 GMT), rose 1.6% to $74.80 a barrel and rose 1.8% to $71.12 a barrel. 

Jobless claims rise by less than expected 

The number of Americans filing for first-time unemployment benefits rose by less than anticipated last week, with coming in at 219,000 in the week ended on Sept. 14, compared with an upwardly revised 231,000 in the prior week.

Economists had forecast a consensus figure of 230,000.

This figure was better than expected, and has allayed to a degree concerns over the health of the US economy, particularly after the Federal Reserve started its latest rate-cutting cycle on Wednesday, trimming interest rates for the first time since March 2020 by a hefty 50 basis points to a range of 4.75% to 5%.

While lower rates usually bode well for economic activity, the Fed’s aggressive cut sparked some concerns over a potential slowdown in economic growth. 

While Fed Chair Jerome Powell helped soothe some of these concerns, he also said that the Fed had no intention of returning to an era of ultra-low interest rates, and that the central bank’s neutral rate was likely to be much higher than seen in the past.

His comments indicated that while interest rates will fall in the near-term, the Fed was likely to keep rates higher in the medium-to-long term.

US inventories fall, but product stockpiles up 

Government data released on Wednesday showed a bigger-than-expected, 1.63 million barrel draw in .

While the draw was much bigger than expectations for a draw of 0.2 mb, it was also accompanied by builds in and inventories. 

The builds in product inventories sparked increased concerns that U.S. fuel demand was cooling as the travel-heavy summer season wound to a close. 

Looking ahead, some expect further draws in domestic crude stocks as exports reaccelerate. 

“We look for a significant rebound in exports across crude and products this week. Among products, our preliminary expectations point to draws in gasoline (-1.5 MM BBL) and distillate (-3.7 MM BBL) with a build in jet (+0.5 MM BBL),” Macquarie said in a recent note.

Crude deficit could boost Brent 

Still, prices could be bolstered in the near-term by demand possibly outstripping supply in the fourth quarter, according to analysts at Citi.

A reported decision by the Organization of the Petroleum Exporting Countries and its allies to delay the beginning of a tapering in voluntary output cuts, along with ongoing supply losses in Libya, is predicted to contribute to a oil market deficit of around 0.4 million barrels per day in the final three months of 2024, the Citi analysts said.

They added that such a trend could offer some temporary support to Brent “in the $70 to $75 per barrel range.”

Meanwhile, the benchmark could be further boosted by a potential rebound in recently tepid demand from top oil importer China, the analysts said.

But they flagged that they still anticipate “renewed price weakness” in 2025, with Brent on a path to $60 per barrel due to an impending surplus of one million barrels per day.

(Peter Nurse, Ambar Warrick contributed to this article.)

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