Category: Business

New Voice AI Assistant Gives Roofing Contractors a Competitive Edge in Storm-Damage Sales

SCOTTSDALE, AZ / ACCESS Newswire / July 10, 2025 / Roofing contractors in storm-affected regions are losing up to 30% of potential jobs due to missed calls and delayed follow-ups, according to industry data. To address this costly gap, Scottsdale-based Convert Peak has launched Phonetix A.I., an advanced voice-powered assistant designed to automate lead response, qualification, and scheduling for roofing businesses.

With homeowners demanding near-instantaneous responses, manual follow-ups, sticky notes, and unanswered voicemails can no longer keep up with homeowner expectations. Phonetix A.I. leverages conversational voice AI and SMS workflows to engage leads immediately, ensuring no opportunity is left on the table.

“Speed-to-lead isn’t just a buzzword-it’s the difference between winning and losing jobs in residential construction,” said DeShawn Tavilla, founder of Convert Peak. “Phonetix A.I. empowers roofing contractors to respond faster than ever, reclaiming lost opportunities and streamlining operations without adding overhead.”

Key Features of Phonetix A.I.:

1. Instant Voice Response: Answers inbound calls 24/7, even outside business hours.

2. Smart Lead Qualification: Captures critical details like address, insurance status, and damage type.

3. Automated Scheduling: Matches homeowner availability and books inspections seamlessly.

4. CRM Integration: Updates records in real-time and notifies sales teams of booked jobs.

Proven Results:
Early adopters of Phonetix A.I. have reported significant improvements, including:

• A 25% increase in appointment bookings without additional staff.

• A reduction in unqualified leads and unnecessary callbacks.

• Faster lead qualification, particularly for storm restoration and insurance-based jobs.

Why It Matters:
A recent B2B Marketing Trends report revealed that 40% of local trades businesses are losing revenue due to slow response systems. Phonetix A.I. addresses this challenge head-on, providing roofing contractors with the tools they need to stay competitive in a fast-paced market.

About Phonetix A.I.:
Phonetix A.I. joins Convert Peak’s growing suite of sales automation tools, offering voice and SMS workflows, conversational AI, and CRM integration tailored to the unique needs of roofing, construction, and home service businesses.

About Convert Peak:
Convert Peak is a performance optimization agency dedicated to helping home service companies nationwide maximize their revenue potential. Specializing in high-converting ad funnels, AI-driven customer engagement, and lead recovery systems, Convert Peak transforms inquiries into booked revenue at scale. Learn more at https://convertpeak.com.

Media Contact:
DeShawn Tavilla, Founder
Email: deshawn@convertpeak.com | A.I. Voice Assistant: 623-294-4940

SOURCE: Convert Peak

View the original press release on ACCESS Newswire

NEW YORK, NY and AUSTIN, TX / ACCESS Newswire / July 10, 2025 / Terra Innovatum Srl (“Terra Innovatum,” or the “Company”), a developer of micro-modular nuclear reactors, and GSR III Acquisition Corp. (Nasdaq:GSRT), a publicly traded special purpose acquisition company, today announcedthat Alessandro Petruzzi, Co-Founder and CEO of Terra Innovatum, Giordano Morichi, Partner, Chief Business Development Officer & Investor Relations of Terra Innovatum, and Anantha Ramamurti, President, Chief Financial Officer and Director of GSRT will participate in a fireside chat at H.C. Wainwright’s Powering the Future: Advancing Innovation Through Nuclear virtual conference.

The virtual fireside chat will take place on Tuesday, July 15, 2025, at 9:30 am ET. A live and archived webcast of the presentation will be accessible on the investors section of Terra Innovatum’s website at https://www.terrainnovatum.com/investors.

Following the fireside chat, management will be available for virtual one-on-one investor meetings. To schedule a meeting, please reach out to an H.C. Wainwright representative or TerraIR@allianceadvisors.com.

ABOUT TERRA INNOVATUM & SOLO^TM

Terra Innovatum’s mission is to make nuclear power accessible. We deliver simple and safe micro-reactor solutions that are scalable, affordable and deployable anywhere 1 MWe at a time.

Terra Innovatum is a pioneering force in the energy sector, dedicated to delivering innovative and sustainable power solutions. Terra Innovatum plans to leverage cutting-edge nuclear technology through the SOLO™ Micro-Modular Reactor (SMR™) to provide efficient, safe, and environmentally conscious energy. With a mission to address global energy shortages, Terra Innovatum combines extensive expertise in nuclear industry design, manufacturing, and installation licensing to offer disruptive energy solutions. Committed to propelling technological advancements, Terra Innovatum and SOLO™ are dedicated to fostering prosperity and sustainability for humankind.

It is anticipated that SOLO™ will be available globally within the next three years. Conceptualized in 2018 and engineered over six years by experts in nuclear safety, licensing, innovation, and R&D, SOLO™ addresses pressing global energy demands with a market-ready solution. Built from readily available commercial off-the-shelf components, the proven licensing path for SOLO™ enables rapid deployment and minimizes supply chain risks, ensuring final cost predictability. Designed to adapt with evolving fuel options, SOLO™ supports both LEU+ and HALEU, offering a platform ready to transition to future fuel supplies.

SOLO™ will offer a wide range of versatile applications, providing CO2-free, behind-the-meter, and off-grid power solutions for data centers, mini-grids serving remote towns and villages, and large-scale industrial operations in hard-to-abate sectors like cement production, oil and gas, steel manufacturing, and mining. It also has the ability to supply heat for industrial applications and other specialized processes, including water treatment, desalination and co-generation. Thanks to its modular design, SOLO™ can easily scale to deliver up to 1GW or more of CO2-free power with a minimal footprint, making it an ideal solution for rapidly replacing fossil fuel-based thermal plants. Beyond electricity and heat generation, SOLO™ can also contribute to critical applications in the medical sector by producing radioisotopes essential for oncology research and cancer treatment.

To learn more, visit: www.terrainnovatum.com.

CONTACTS

Giordano Morichi
Partner, Chief Business Development Officer & Investor Relations
Terra Innovatum Srl
E: g.morichi@terrainnovatum.com
W: https://www.terrainnovatum.com/

Anantha Ramamurti
President, Chief Financial Officer
GSR III Acquisition Corp
E: anantha@gsrspac.com
P: (949) 468-7434

Nicholas Hresko-Staab
Vice President
Investor & Media Relations
Alliance Advisors IR
E: TerraIR@allianceadvisors.com

IMPORTANT INFORMATION FOR SHAREHOLDERS

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or constitute a solicitation of any vote or approval.

In connection with the business combination, a Dutch public limited liability company (“Pubco”), GSR III Acquisition Corp. (“GSRT”) and Terra Innovatum s.r.l. (“Terra Innovatum” and, together with GSR III and Pubco, the “Registrant Parties”) have filed with the SEC a registration statement on Form S-4 (the “Registration Statement”), which includes a preliminary prospectus of Pubco relating to the offer of securities to be issued in connection with the business combination, and a preliminary proxy statement of GSRT to be distributed to holders of GSRT’s ordinary shares in connection with GSRT’s solicitation of proxies for a vote by GSRT’s shareholders with respect to the Business Combination and other matters described in the Registration Statement. The Registrant Parties also plan to file other documents with the SEC regarding the business combination. After the Registration Statement has been declared effective by the SEC, a definitive proxy statement/prospectus will be mailed to the shareholders of GSRT. INVESTORS OF THE REGISTRANT PARTIES ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS CONTAINED THEREIN (INCLUDING ALL AMENDMENTS AND SUPPLEMENTS THERETO) AND ALL OTHER DOCUMENTS RELATING TO THE BUSINESS COMBINATION THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION.

Investors will be able to obtain free copies of the proxy statement/prospectus and other documents containing important information about the Registrant Parties once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. In addition, the documents filed by GSRT may be obtained free of charge by written request to GSRT at 5900 Balcones Drive, Suite 100, Austin TX 78731.

PARTICIPANTS IN THE SOLICITATION

Each of the Registrant Parties, and their respective directors and executive officers, may be considered participants in the solicitation of proxies with respect to the potential transaction described in this communication under the rules of the SEC. Information about the directors and executive officers of GSRT is set forth in GSRT’s filings with the SEC. Information regarding other persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders in connection with the potential transaction and a description of their direct and indirect interests will be set forth in the Registration Statement (and will be included in the proxy statement/prospectus) and other relevant documents when they are filed with the SEC. These documents can be obtained free of charge from the sources indicated above.

FORWARD LOOKING STATEMENTS

The statements contained in this press release that are not purely historical are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding our expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects on GSRT and the other Registrant Parties. There can be no assurance that future developments affecting GSRT and the other Registrant Parties will be those that we have anticipated. These forward-looking statements speak only as of the date this press release is delivered and involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the definitive agreements with respect to the Business Combination; (2) the outcome of any legal proceedings that may be instituted against GSRT, any of the Registrant Parties, the combined company or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (3) the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of GSRT or the SEC’s declaration of the effectiveness of the Registration Statement (which will include the proxy statement/prospectus contained therein) to be filed by the Registrant Parties or to satisfy other conditions to closing; (4) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (5) the ability of Pubco to meet stock exchange listing standards following the consummation of the Business Combination; (6) the risk that the Business Combination disrupts current plans and operations of Terra Innovatum as a result of the announcement and consummation of the Business Combination; (7) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees; (8) costs related to the Business Combination, including the reorganization described in the business combination agreement; (9) changes in applicable laws or regulations; (10) the possibility that the Registrant Parties or the combined company may be adversely affected by other economic, business, and/or competitive factors; (11) the amount of redemption requests made by GSRT shareholders and (12) other risk factors described herein as well as the risk factors and uncertainties described in the Form S-4 and GSRT’s other filings with the SEC, as well as any further risks and uncertainties to be contained in the proxy statement/prospectus filed after the date hereof. In addition, there may be additional risks that neither GSRT nor any of the other Registrant Parties presently know, or that GSRT or the other Registrant Parties currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward- looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made.

None of GSRT, the other Registrant Parties, or any of their respective affiliates, officers, employees or agents, makes any representation or warranty, either express or implied, in relation to the fairness, reasonableness, adequacy, accuracy, completeness or reliability of the information, statements or opinions, whichever their source, contained in this press release or any oral information provided in connection herewith, or any data it generates and accept no responsibility, obligation or liability (whether direct or indirect, in contract, tort or otherwise) in relation to any of such information. GSRT, the other Registrant Parties and their respective affiliates, officers, employees and agents further expressly disclaim any and all liability relating to or resulting from the use of this press release and any errors therein or omissions therefrom. Further, the information contained herein is preliminary, is provided for discussion purposes only, is only a summary of key information, is not complete and is subject to change without notice.

In addition, the information contained in this press release is provided as of the date hereof and may change, and neither GSRT nor the other Registrant Parties undertakes any obligation to update or revise any forward- looking statements, whether as a result of new information, inaccuracies, future events or otherwise, except as may be required under applicable securities laws.

SOURCE: TERRA INNOVATUM SRL

View the original press release on ACCESS Newswire

SCOTTSDALE, AZ / ACCESS Newswire / July 10, 2025 / Michael Bradley has spent more than 30 years building one of the most trusted independent advisory firms in the country. But today, his focus isn’t just on managing wealth; it’s on preparing the next generation to carry that mission forward.

Bradley, founder of Bradley Wealth, recently marked his 60th birthday. While his energy for the work remains as strong as ever, his attention has shifted toward succession: ensuring continuity for clients, strengthening the culture he built, and mentoring rising leaders who can shape the firm’s future with the same integrity and heart.

That’s where Brandon Scott and Alex Cohen come in, two partners Bradley personally brought into the business for their character as much as their credentials. “That’s why I brought on Brandon Scott and Alex Cohen as business partners,” he said. “They’re not just rising stars in the industry, they’re men of incredible intellect, strong work ethic, and deep heart. I trust them fully, and our clients do, too.“

Brandon Scott joined Bradley Wealth in 2017, following a path sparked by childhood curiosity. Raised in Nebraska, Scott grew up watching CNBC with his father, which planted the seeds of fascination with the markets. After earning his finance degree from Buena Vista University, he worked in fintech and wealth management before finding a home at Bradley Wealth. Today, he serves as the firm’s Portfolio Manager, known for his sharp analytical mind, deep empathy, and passion for music, which makes him a favorite at the office.

Alex Cohen, meanwhile, brings a background in competitive sports and a strategic mindset honed on the basketball court. A former college athlete, Cohen began his financial career in New York before joining the firm in 2020. Now Manager of Financial Planning and a CERTIFIED FINANCIAL PLANNER™, Cohen is the architect behind Bradley Wealth’s cutting-edge planning software and a trusted partner to clients navigating complex transitions.

Together, Scott and Cohen represent the firm’s future, but their influence is already present in the day-to-day operations. Under Bradley’s mentorship, both men have stepped into leadership roles, helping evolve client experiences while staying rooted in the firm’s founding values: clarity, service, and deep personal connection.

For Bradley, the next chapter of his firm isn’t about stepping back. It’s about stepping into his role as mentor and steward of the values he’s spent two decades cultivating. His view of success isn’t centered on metrics but on meaning. “So yes, $300 million in AUM is something I’m proud of,” he says. “But what I’m most proud of is how we got there. With integrity. With care. And always, always one relationship at a time.”

As Bradley Wealth approaches its next chapter, that legacy is clearly in motion, led by a team ready to honor the past while building boldly toward the future.

Bradley Wealth
yourfuture@bradleywealth.com
Scottsdale, Arizona

SOURCE: Bradley Wealth

View the original press release on ACCESS Newswire

Company strategy: In discussions with multiple potential animal health company partners to collaborate to bring Canalevia^®, conditionally approved for CID, to regulatory approval and commercialization for general diarrhea globally

Diarrhea is one of the most common reasons owners bring their dog to the veterinarian and the second most common reason for visits to the veterinary emergency hospital, yet there are currently no FDA-approved drugs to treat general diarrhea in dogs

Jaguar CEO Lisa Conte presenting July 17 at Emerging Growth Conference to provide updates on near-term catalysts; Click here to register

SAN FRANCISCO, CA / ACCESS Newswire / July 10, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), under its Jaguar Animal Health tradename for the veterinary market, today announced that four dogs have now been enrolled in Jaguar’s ongoing field study of Canalevia-CA1, the company’s U.S. Food and Drug Administration (FDA) conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, and enrollment is continuing. Six veterinary oncology clinics have signed on to take part in this study, and Jaguar is in discussions with other veterinary oncology clinics regarding possible participation.

“Jaguar’s primary objective for Canalevia (crofelemer delayed-release tablets) is to identify a partner with which to collaborate to achieve our three parallel goals for the drug: Obtain approval in the European Union for Canalevia for treatment of general diarrhea in dogs based on existing Jaguar study data; maintain continuity of availability in the U.S. of Canalevia for treatment of CID in dogs; and to expand the U.S. indication from CID in dogs to treatment of general diarrhea in dogs,” said Lisa Conte, Jaguar’s Founder and CEO. “I’m pleased to report that Jaguar is currently in discussions with multiple potential animal health company partners to collaborate to bring Canalevia to regulatory approval and commercialization for general diarrhea globally.”

Canalevia contains crofelemer, a plant-based botanical prescription drug that modulates chloride channels in the gastrointestinal tract to reduce diarrhea. Importantly, Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics.

“In the EU, as we announced, it may be possible to obtain approval of Canalevia for treatment of general diarrhea in dogs based on the results of a study Jaguar completed in 200 dogs with general diarrhea,” Conte said. “While this completed trial did not meet its stated primary endpoint, the study results are clinically significant when analyzed using an alternate, simplified endpoint, defining treatment success as any dog that had no episodes of diarrhea following the first treatment with either Canalevia or placebo. Using this revised endpoint, the study data shows that dogs treated with Canalevia had significantly better outcomes – with fewer watery stools and significant improvement in fecal scores compared to placebo-treated dogs.”

Jaguar plans to submit a dossier to the European Medicines Agency (EMA) to outline the results of the updated analysis of the company’s completed study of Canalevia in dogs with general diarrhea. If acceptable to the EMA, the company will then submit a Marketing Authorization Application (MAA) for Canalevia for general diarrhea in dogs. If the application is approved, Canalevia will be marketable for treatment of general diarrhea in dogs in all 27 EU member countries.

Data from the European Pet Food Industry Federation concluded that there were 104 million dogs in Europe in 2022. “We’ve been pleased with the marketplace reception of crofelemer for treatment of CID in dogs in the U.S. and believe there is clearly an unmet medical need for a product for the much larger market of treatment of general diarrhea in dogs – both in the U.S. and the EU,” said Conte. “We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to identifying a partner to fund and execute development and commercialization of crofelemer for the treatment of general diarrhea in the U.S. and/or globally. Forging a partnership for this purpose is a key focus of our business development efforts in 2025 and has been designated as a key potential catalyst for the company this year.”

Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. According to the American Veterinary Medical Association, there were an estimated 89.7 million dogs in the United States in 2024, with nearly half (45.5%) of U.S. households owning a dog in 2024. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs.

Canalevia-CA1, a canine-specific formulation of crofelemer, Jaguar’s novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, is available from multiple leading veterinary distributors in the U.S., including Chewy.

The objective of the ongoing, prospective, randomized, open-label field study in dogs undergoing chemotherapy treatment across the U.S. is to collect real-world data to demonstrate real-world evidence of the clinical effectiveness for Canalevia-CA1 for the treatment of CID in dogs to support potential full FDA approval of the drug for this indication. Dogs enrolled in this study will be randomly assigned to receive a prescription of Canalevia-CA1 as a treatment for CID or be randomly selected to the control group.

Participation Instructions for Jaguar’s Virtual Presentation at the Emerging Growth Conference

When: Thursday, July 17, 2025 from 2:55 – 3:05 PM Eastern

Where: Online (Click Here)

Registration link for conference: Click Here

Replay: An archived webcast of the presentation will be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel.

About Conditional Approval and Full Approval

Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA’s conditional approval allows a drug company to legally promote, advertise and sell the animal drug for the labeled uses before proving it meets the “substantial evidence” standard of effectiveness for full approval. The conditional approval is valid for one year. The drug company can ask the FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. To receive a renewal from the FDA, the company must show active progress toward proving “substantial evidence of effectiveness” for full approval. After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will, at some stage in their life, develop cancer, and almost 50% of dogs over age 10 will develop cancer.¹ According to the National Cancer Institute, which is part of the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S.

Due to the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and primary care veterinarians, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the U.S. veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID in dogs.

About Canalevia^®-CA1

Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is currently conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval. Jaguar has also received Minor Use in a Major Species (MUMS) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a “small number” threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use.

About Crofelemer

Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi^® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit www.napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that Jaguar management will present at the July 2025 Emerging Growth Conference, Jaguar’s expectation that it will identify a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S and/or globally, Jaguar’s expectation that it may be possible to obtain approval of Canalevia in the EU for treatment of general diarrhea in dogs based on the results of a study Jaguar completed in 200 dogs with general diarrhea, Jaguar’s expectation that it will submit a dossier to the EMA to outline the results of the updated analysis of the company’s completed study of Canalevia in dogs with general diarrhea, Jaguar’s expectation that, if the submitted dossier is acceptable to the EMA, the company will then submit a MAA to the EMA for Canalevia for general diarrhea in dogs, and Jaguar’s expectation that the field study of Canalevia-CA1 for the treatment of CID in dogs will support potential full FDA approval of the drug for this indication. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

¹ “Cancer in Pets.” American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease

CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company’s COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company’s COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA).

“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”

Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus 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® is a registered trademark of Moderna.

INDICATION

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine to protect you 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 SPIKEVAX may not protect all people who receive the vaccine.

IMPORTANT SAFETY INFORMATION

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

What are the risks of SPIKEVAX?

There is a very small chance that 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 SPIKEVAX. For this reason, the healthcare provider may ask you or your child to stay for a short time at the place where you or your child 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 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.

Other side effects that have been reported 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) were also reported

Tell the healthcare 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 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 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 see the SPIKEVAX Full Prescribing Information.

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 an updated Spikevax vaccine for eligible populations in the U.S. for the 2025-2026 respiratory virus season. 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