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CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE, Moderna’s new COVID-19 vaccine, is approved for individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. With the U.S. FDA’s decision, Moderna’s updated vaccines are expected to be available in the coming days.

“Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season.”

The updated vaccine composition is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be developed with a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.

Moderna’s updated COVID-19 vaccines targeting LP.8.1 have already been granted approval by regulators in Canada, Europe, Japan, Switzerland and other countries. Additional regulatory applications are under review around the world in preparation for the coming season.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Spikevax® and mNEXSPIKE®are registered trademarks of Moderna.

What is mNEXSPIKE® (COVID-19 Vaccine, mRNA) AND SPIKEVAX® (COVID-19 Vaccine, mRNA)?

mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who are:

• 65 years of age and older, or

• 12 years through 64 years of age at high risk for severe COVID-19.

SPIKEVAX is a vaccine to protect against COVID-19. SPIKEVAX is for people who are:

• 65 years of age and older, or

• 6 months through 64 years of age at high risk for severe COVID-19.

Vaccination with mNEXSPIKE or SPIKEVAX may not protect all people who receive the vaccine.

IMPORTANT SAFETY INFORMATION

You or your child should not get mNEXSPIKE® or SPIKEVAX® if you had a severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX, any Moderna COVID-19 vaccine, or to any ingredient in these vaccines.

What are the risks of mNEXSPIKE and SPIKEVAX?

There is a very small chance that mNEXSPIKE or SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE or SPIKEVAX. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include:

• Trouble breathing

• Swelling of your face and throat

• A fast heartbeat

• A rash all over your body

• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving mNEXSPIKE or SPIKEVAX, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.

Side effects that have been reported in clinical trials with mNEXSPIKE include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness.

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever

Side effects that have been reported in clinical trials with SPIKEVAX include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and redness

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite.

• Fainting and febrile seizures (convulsions during a fever) have also been reported

Tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:

• have any allergies

• had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine

• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

• have a fever

• have a bleeding disorder or are on a blood thinner

• are immunocompromised or are on a medicine that affects your immune system

• are pregnant or plan to become pregnant

• are breastfeeding

• have received any other COVID-19 vaccine

• have ever fainted in association with an injection

These may not be all the possible side effects of mNEXSPIKE and SPIKEVAX. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

Please click for mNEXSPIKE Full Prescribing Information and Information for Recipients and Caregivers.

Please click for SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of Moderna’s updated COVID vaccines; the efficacy, safety and tolerability of Moderna’s COVID vaccines; and Moderna’s regulatory applications under review around the world. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

Founders Dr. Anatoly and Oksana Ripa bring their patient-focused approach and modern dental care to new communities in North Miami-Dade.

MIAMI, FL / ACCESS Newswire / August 27, 2025 / Smile Creators, a boutique dental practice founded by Dr. Anatoly Ripa and Oksana Ripa, has officially expanded with a new clinic in Sunny Isles Beach, and a third location is coming soon to Aventura. With their flagship office in Bay Harbor Islands already serving a diverse Miami clientele, this expansion marks an exciting new chapter for one of the region’s most innovative dental brands. Dr. Ripa, a graduate of Stony Brook University with over 27 years of experience in the field, is known for his personalized approach to aesthetic and restorative dentistry. Fluent in English, Russian, and Ukrainian, he has built long-term relationships with patients across the Bal Harbour and North Miami areas. Alongside him, Oksana Ripa has helped shape Smile Creators into a recognizable name – developing a patient experience that blends hospitality, precision care, and community connection.

The expansion into Sunny Isles Beach reflects a growing demand for access to personalized, high-quality dental care delivered in a calming and modern environment. The upcoming Aventura office, set to open later this year, will extend the practice’s reach even further into North Miami-Dade.

“Our goal has always been to make patients feel confident, cared for, and in control of their health,” said Dr. Anatoly Ripa. “Every new space we create reflects that vision.”

Technology plays a central role in the Smile Creators’ vision. Each location incorporates modern diagnostic tools and workflow systems that support efficient, individualized treatment. The clinical environment – designed under the creative direction of Oksana Ripa – also avoids the traditional feel of a dental office, opting instead for a relaxed, spa-like atmosphere that helps patients feel at ease.

While many patients visit Smile Creators for cosmetic improvements, the clinic maintains a full-scope dental approach that supports oral health at every stage of life. As the practice continues to grow, its core values remain centered on trust, transparency, and a commitment to long-term results.

The Smile Creators team continues to connect with patients both in-person and online. For more information about their services or to schedule a consultation, visit www.smilecreators.com or follow the clinic’s official Instagram at @smilecreators_miami for updates, behind-the-scenes content, and news on the upcoming Aventura launch.

“We’re proud to grow with the communities we serve,” said Oksana Ripa. “For us, expansion isn’t just about more locations – it’s about deeper relationships with the people who walk through our doors.”

In addition to its clinical services, Smile Creators is known for its bold branding – from its signature yellow vehicle seen across Miami to its stylish clinic interiors and strong social media identity. The brand’s connection to the city remains a central part of its success story.

The Sunny Isles Beach location is now open to patients. The Aventura office is currently in development, with a grand opening expected later this year.

Contact:

VUGA Media Group
Miami, FL
Alice Bay
contact@vugamediagroup.com

SOURCE: VUGA Media Group

View the original press release on ACCESS Newswire

CHARLOTTE, NC / ACCESS Newswire / August 27, 2025 / For high-income earners and business owners, taxes are often their single greatest recurring expense. Smart planning is not just about creating wealth but also about safeguarding it from unnecessary erosion. Judson Gee, Managing Partner at JHG Financial, explains that the recently passed One Big Beautiful Bill Act (OBBBA) puts two major tools at the forefront of tax strategy: the reform of the Opportunity Zone program and the permanent restoration of 100 percent bonus depreciation. When combined, they offer investors a new chance to lower their tax obligations and possibly direct funds toward more significant economic results.

Opportunity Zones were first proposed in 2017 with the goal of bringing private investment into local infrastructure, companies, and housing, therefore reviving underperforming towns. A significant portion of the billions of dollars that poured into the designated areas were focused on high-value projects, such as student apartments, luxury homes, and developments that were already under way before the tax incentive. Because reporting was optional, irregular, and frequently ambiguous, officials lacked conclusive proof of the program’s actual benefits to low-income neighborhoods. “The first round of Opportunity Zones showed us both the potential and the flaws of the program,” Gee notes. “OZ 2.0 fixes many of those issues by making the program permanent and requiring transparency so we can finally measure real community outcomes.”

Still, examples like the Erie Downtown Development Corporation in Pennsylvania or the Kresge Foundation’s deployment of 22 million dollars into impact funds demonstrate that, with strong partnerships and accountability, Opportunity Zones can function as intended. Since then, Capital Square has delivered notable developments supported by its Opportunity Zone funds. In Raleigh, North Carolina, the Maeve apartment community was completed through Capital Square Opportunity Zone Fund VI and has been well received. In Charleston, South Carolina, The Nickel Hotel was developed through Capital Square Opportunity Zone Fund IV and has drawn strong attention in the city’s historic district.

By implementing Opportunity Zones 2.0, which goes into effect on January 1, 2027, the OBBBA hopes to address such deficiencies. The sunset clause that made long-term planning challenging under the previous regulations has been removed, making the program permanent. Investors will have access to a rolling five-year deferral of capital gains, a uniform 10 percent basis step-up after five years, and complete exemption of appreciation after a ten-year hold. Importantly, OZ 2.0 introduces enhanced incentives for rural areas, granting a 30 percent step-up in basis and lowering the substantial improvement threshold to 50 percent. Every ten years, governors will have the authority to reclassify tracts, enabling the program to adapt to changing economic circumstances. Equally important, new reporting and transparency rules will make funds answerable for the kinds of enterprises they support, the quantity of housing units they build, and the employment they create.

While investors wait for the new rules to kick in, many will face what analysts are calling the “2026 dead zone,” a period where existing Opportunity Zone benefits are winding down and the new benefits have yet to begin. Strategic planning will be essential during this time. As Gee notes, “A lot of people think Opportunity Zones are done, but the truth is they have just been upgraded. OZ 2.0 is one of the most powerful tools we have ever seen for turning capital gains into long-term wealth, and it is here to stay.”

There are other provisions that are changing tax policy besides Opportunity Zones. Additionally, for assets placed in operation after January 19, 2025, the OBBBA permanently reinstated 100 percent bonus depreciation. Bonus depreciation was formerly scheduled to fade off, falling to 40% by 2025 and then completely ceasing to exist by the end of the decade. The entire cost of qualified property, including furniture, machinery, equipment, and other real estate renovations, can now be written off by investors and businesses in the year that the item is put into service. Combining cost segregation studies with bonus depreciation can result in large early deductions for real estate investors, enhancing cash flow and opening up reinvestment options.

A new incentive for qualified production property was also created by the legislation, providing a 100 percent deduction for manufacturing facilities located in the United States that were built within certain periods. This is intended to promote production reshoring, but it also gives investors a strong tool if they are prepared to combine aggressive tax planning with long-term development.” Clients who use cost segregation properly can unlock six- or seven-figure deductions without selling a thing,” Gee explains. “That is real liquidity and long-term flexibility.”

Particularly fascinating is the junction of Opportunity Zones 2.0 and accelerated depreciation. Consider an investor who constructs or upgrades a manufacturing plant within a recently established rural Opportunity Zone. That project might benefit from the long-term tax-free growth potential of the OZ structure as well as immediate 100% write-offs under bonus depreciation regulations. One of the most alluring wealth-building frameworks in decades is the opportunity to combine permanent capital gains relief with upfront deductions.

However, the revisions also emphasize how important accountability is. Opponents of the original Opportunity Zone program contend that the advantages will continue to accrue disproportionately to investors rather than communities in the absence of thorough reporting. Although OZ 2.0 provides the necessary transparency, it is unclear if these protections will result in quantifiable local effects. It is evident that high-net-worth investors now have a more stable and adaptable framework to use their money in ways that balance long-term growth with tax efficiency.

The message is straightforward: tax planning cannot be reactive. “If you are not taking advantage of these strategies, you are giving away more money to the IRS than you should,” Judson adds. “The goal is not just to save taxes today but to use those savings to create durable wealth for the future.”

Investors can lower their immediate tax obligations, build more effective portfolios, and take part in initiatives that, when done right, also generate genuine community value by combining accelerated depreciation with the enlarged Opportunity Zones 2.0 program. These methods provide both financial benefit and the possibility of significant impact at a time of increased tax scrutiny and accountability demands.

Judson H. Gee, CEP
7045363423
judson.gee@jhgfinancial.com
Charlotte, NC

SOURCE: Judson H. Gee, CEP

View the original press release on ACCESS Newswire

Capital Guard AU Pty Ltd shares five principles to help Australians focus on capital protection, steady income, and smarter fixed-income investing amid shifting interest rates.

SYDNEY, AU / ACCESS Newswire / August 27, 2025 / With interest rates falling, many Australians are shifting from growth strategies to income and capital protection. Capital Guard AU Pty Ltd, an ASIC-authorised financial services provider, has outlined five principles to guide long-term fixed income investment strategies.

Fixed-income investments such as term deposits, investment bonds, and secure fixed-income bonds are gaining interest for their stability and predictable returns. As bank term deposit rates fluctuate, more investors are reconsidering how to invest in fixed-income with confidence.

1. Capital preservation comes first

Investment bonds and fixed-term deposits help protect capital while generating income. This is especially important in retirement, when recovery from losses is limited. A balanced portfolio can support both access and stability.

2. Plan for long-term income

Short-term rate changes can lead to poor decisions. Strategies like laddered term deposits or staggered bonds help manage reinvestment risk and support income over 10 to 20 years. Long-term fixed income investment strategies tend to hold up better through rate cycles.

3. Understand more than the headline rate

An attractive 6% offer might not tell the full story. Investors need to consider factors like credit quality, lock-in terms, compounding, and early withdrawal penalties. Comparing fixed-term deposit rates and bond yields without these details can lead to poor outcomes.

4. Diversify terms and providers

Relying on one bank, product, or maturity date increases risk. Diversifying across institutions and timeframes helps reduce exposure to rate changes. Combining short-term deposits with medium-term bonds adds flexibility and access.

5. Consider bonds as a strategic alternative

Compared to traditional term deposit account options, bonds can offer stronger yields and flexible access. Capital Guard AU Pty Ltd offers tailored portfolios that include some of the best Australian bond rates and secure fixed-income bonds available today. Term deposits offer better capital protection, but bonds offer yields and flexible access.

Growing interest in fixed-income

More Australians are turning to fixed-income investments for a stable income and capital protection. With term deposit specials and shifting rates, many are seeking to lock in value.

Comparing bank term deposit rates and planning a secure fixed income strategy is key to long-term investing success.

For details on how to invest in bonds and find the best bond rates, visit Capital Guard AU Pty Ltd’s website.

About Capital Guard AU Pty Ltd

Capital Guard AU Pty Ltd is an ASIC-authorised financial services provider (AFSL 498434) based in Sydney, offering fixed-income and equity investments, retirement planning, and financial advice. Investors should review the Financial Services Guide and Risk Disclosure Statement and seek licensed advice before making investment decisions.

Risk disclosure

This document is for informational purposes only and does not constitute personal financial advice. Investments in fixed-income products, including bonds and term deposits, carry risks such as credit risk, interest rate risk, liquidity risk, and inflation risk. Past performance is not an indicator of future performance. This article provides general information only and does not constitute personal financial advice. Investors should seek independent advice tailored to their specific circumstances before making investment decisions.

Media Contact

Capital Guard AU Pty Ltd
Level 36, 1 Macquarie Place, Sydney NSW 2000
Email: info@capitalguard.com.au
Phone: +61 2 8551 2719 (Landline available Mon-Fri, 8 am-5 pm AEST)
Hotline: 1300 712 528 (24/7)
Follow Capital Guard AU Pty Ltd on Facebook, LinkedIn, Instagram, X, and YouTube.

SOURCE: Capital Guard AU Pty Ltd

View the original press release on ACCESS Newswire

Executive to lead structuring process focused on scaling proprietary propulsion technology and OEM portfolio.

MONTRÉAL, QUEBEC / ACCESS Newswire / August 27, 2025 / Vision Marine Technologies Inc. (NASDAQ:VMAR) (“Vision Marine” or the “Company”) a pioneer in high-voltage marine propulsion and multi-brand boat retail, today announced the appointment of Maxime Poudrier as Chief Operating Officer (COO).

Mr. Poudrier has been with Vision Marine since serving as Head of Growth & Strategic Partnerships, where he played a pivotal role in the industrialization of the Company’s E-Motion™ 180E high-voltage propulsion system by successfully implementing strategic grant programs, expanding OEM and vendor alliances, and supporting the acquisition and integration of Nautical Ventures. His appointment marks the next step in structuring Vision Marine’s operations to scale as a dual-pillar platform: technology leadership and consumer adoption.

As COO, Mr. Poudrier will lead a Company-wide structuring process to align intellectual property, strategic partnerships, and consumer adoption under a unified execution framework. His mandate includes operational oversight, OEM and vendor management, budgeting and forecasting, sales and service alignment, and human capital planning, ensuring that Vision Marine’s growing patent portfolio, white-label licensing agreements, and propulsion systems are consistently executed across its operations.

“Maxime has demonstrated the rare ability to combine entrepreneurial drive with disciplined execution,” said Alexandre Mongeon, Chief Executive Officer of Vision Marine. “His expertise in M&A, global partnerships, and structured leadership is exactly what Vision Marine needs as we scale our electrification platform and expand through Nautical Ventures. His appointment ensures that our innovation translates directly into execution, recurring revenue, and long-term value creation.”

With more than 10 years of executive leadership across the automotive, mobility, and industrial sectors, Mr. Poudrier has established a strong record of strategic growth and operational execution. Prior to joining Vision Marine, he became the youngest self-made dealer principal in Canada, successfully leading multiple automotive dealerships, and later advised on international M&A mandates for leading manufacturers such as ArcelorMittal. He is also a graduate of executive education programs at Harvard Business School.

This appointment underscores Vision Marine’s commitment to disciplined execution of its proprietary propulsion technology and intellectual property portfolio, ensuring innovation remains at the center of its growth strategy, with Nautical Ventures accelerating adoption.

About Vision Marine Technologies Inc.
Vision Marine Technologies Inc. (NASDAQ:VMAR) is a disruptive marine company offering premium boating experiences across both electric and internal combustion engine (ICE) segments. The Company designs, manufactures, and sells its flagship E-Motion™ 180E high-voltage electric propulsion system, validated through multiple OEM integrations, while also providing consumer access through its Nautical Ventures division. With nine retail locations in Florida and established sales, service, and marina operations, Vision Marine delivers market-ready solutions to meet the evolving needs of recreational boaters and commercial operators.

For more information, please visit www.visionmarinetechnologies.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. These statements relate to, among other things, the anticipated benefits of the appointment of the Company’s Chief Operating Officer, the Company’s strategy, and its growth initiatives. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties. Actual results could differ materially from those anticipated. Vision Marine disclaims any obligation to update these statements except as required by law.

Investor and Company Contact:

Bruce Nurse
Investor Relations
(303) 919‑2913
bn@v‑mti.com

SOURCE: Vision Marine Technologies Inc

View the original press release on ACCESS Newswire