Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD
NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD).
In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing.
In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication.
Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company's expectations at product launch. Mesoblast has continued to expand coverage for Ryoncil® to over 220 million US lives insured by commercial and government payers. To date, 37 of the 51 States provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process. The remainder will come online July 1, 2025, with mandatory coverage for all 24 million lives.
'We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs,' said Mesoblast Chief Executive Dr. Silviu Itescu. 'We are also encouraged by the strength of the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch. We will be providing an update on sales of Ryoncil® in our quarterly activities report at the end of next month.'
About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast's RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast
Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
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For more information, please contact:Paul Hughes
T: +61 3 9639 6036
Allison Worldwide
Emma Neal
T: +1 603 545 4843
E: emma.neal@allisonworldwide.com
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24 minutes ago
- Business Insider
Best Credit Cards in America: Top Credit Card Offers for June 2025
I think about credit cards all the time. As a personal finance journalist, I've covered credit card rewards for a decade and have more than three dozen active cards. It's impossible to name a single credit card that would be perfect for everyone's needs. But knowing what you want from your credit card can help you find your best option. My family and friends frequently ask me, "What's the best credit card?" and "What credit card should I get?" I offer personalized recommendations based on their individual needs and wants, factoring in benefits, rewards, and financial protection they won't get from paying cash or using a debit card. I compiled this list of winners based on that research. I compared welcome offers, ongoing rewards for common expenses, benefits and protections like trip insurance and purchase protection, and reasonable annual fees (or lack thereof) across dozens of credit cards available today. These are the best credit cards you can get right now — you'll find most of them in my own wallet. Best For Card Annual Fee Best for cash rewards Wells Fargo Active Cash® Card $0 (rates and fees) Best for travelers Chase Sapphire Preferred® Card $95 (rates and fees) Best for families Blue Cash Preferred® Card from American Express $0 intro for the first year, then $95 (rates and fees) Best for 0% APR Chase Freedom Unlimited® $0 (rates and fees) Best for young adults Bilt Mastercard® $0 (rates and fees) Best for reward maximizers Discover it® Cash Back $0 What Is the Best Credit Card to Get? I always say there isn't a magical "best credit card" that works for every person. Many people prefer no-annual-fee credit cards because they're easy to keep long-term. Other people don't mind paying a hefty annual sum for premium credit cards with airport lounge access because the benefits of luxury and comfort are worth the cost. Some value travel rewards credit cards, while others prefer to focus on cash-back credit cards. Wherever you fall on each of these spectrums, I encourage you to hone in on what you really need for your personal situation. If you have kids, you may want to forgo airport lounges in favor of free checked bags. If you travel solo, you may want to prioritize credit cards that offer luxury benefits such as hotel elite status and shopping credits. Credit Cards for Families For parents with young children, I recommend credit cards that reward groceries, streaming services, and commuting expenses with flexible points that can be redeemed in many different ways. The Blue Cash Preferred® Card from American Express checks all of these boxes. I also suggest choosing a credit card that offers travel insurance coverage, since little kids often get sick during or right before a big trip. If you have to cancel or reschedule that expensive Disney vacation, it's always nice to recoup some of your nonrefundable expenses. The Chase Sapphire Preferred® Card is my top choice recommendation for this benefit because it's so well-rounded on all of these fronts. Credit Cards for Young Adults Young adults in college or early in their careers often find themselves spending a lot of money on rent while dining out with friends or colleagues every night. At the same time, they often value the simplicity of loading a single credit card into Apple Pay and using it for every transaction. The Bilt Mastercard® is perfect for this life stage, with gamified rewards and bonus points on common lifestyle expenses. If you're a first-time credit card applicant or a student with minimal income, you may want to consider one of the best starter credit cards or the best student credit cards. 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While there's a case to be made for paying a high annual fee when you're getting high value in return, most people dislike the idea of paying money to spend money. Value: A good credit card should offer enough value to offset any annual fee several times over. When evaluating no-annual-fee cards, I focused on the ones that provide the best benefits or most generous rewards. Read Business Insider's guide to points and miles valuations to learn what your credit card rewards are worth, and learn more about how we rate credit cards. Wells Fargo Active Cash® Card The Wells Fargo Active Cash® Card is ideal for people who prioritize flat-rate cash rewards. Its ease of use makes it our pick for the best credit card for earning cash rewards. This card is all about simple math and cash, earning unlimited 2% cash rewards on purchases across all categories. Wells Fargo Rewards can easily be redeemed for statement credits, gift cards, travel, and more. 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Yahoo
39 minutes ago
- Yahoo
Scale AI Announces Next Phase of Company's Evolution
Significant Investment and Expanded Commercial Relationship with Meta will Fuel Long-Term Growth Founder and CEO, Alexandr Wang, Joins Meta to Work on Meta's AI Efforts Jason Droege, Tech Industry Veteran and Scale Chief Strategy Officer, Named Interim CEO SAN FRANCISCO, June 13, 2025--(BUSINESS WIRE)--Scale AI, Inc. ("Scale" or the "Company"), the humanity-first AI company, today announced a significant new investment from Meta Platforms, Inc. (Nasdaq: META) that values Scale at over $29 billion. The agreement will also substantially expand Scale and Meta's commercial relationship to accelerate deployment of Scale's data solutions. In addition, Scale's founder, Alexandr Wang, is joining Meta to work on Meta's AI efforts. Wang will continue to serve as a director on the Scale Board of Directors and support Scale's ongoing work to unlock the power of AI and keep human values at the forefront. Scale's Board of Directors has appointed Chief Strategy Officer, Jason Droege, to serve as the Company's Interim Chief Executive Officer. Droege joined Scale in September 2024 with more than 20 years of experience building and leading iconic technology companies that improve everyday life, including Uber Eats and Axon. At Scale, Droege's leadership has been instrumental to the growth and achievements of AI labs and work with enterprise customers. Scale will utilize the proceeds of the deal to accelerate innovation and strengthen strategic partnerships with customers. In addition, Scale will distribute proceeds from Meta's investment to Scale shareholders and vested equity holders, providing them with substantial liquidity as well as the opportunity to continue participating in Scale's success as ongoing equity holders of the Company. Following its investment, Meta will hold a minority of Scale's outstanding equity. Scale remains an independent leader in AI, committed to providing industry-leading AI solutions and safeguarding customer data. Having played a pivotal role in accelerating AI development from its inception, Scale will continue to partner with leading AI labs, multinational enterprises, and governments to deliver expert data and technology solutions through every phase of AI's evolution. Alexandr Wang, Founder of Scale: "AI is one of the most revolutionary technologies of our time, with unlimited possibility and far-reaching influence on how people, businesses and governments succeed. Scale bridges the gap between human values and technology to help our customers realize AI's full potential. Meta's investment recognizes Scale's accomplishments to date and reaffirms that our path forward – like that of AI – is limitless. "I'm delighted that Jason will lead the next steps in Scale's journey and bring his experience and skill to continue its success. Our bench is deep and I'm confident that we'll continue best serving our valued customers, providing the highest quality data, and building customized AI applications that transform businesses and governments." Jason Droege, Interim Chief Executive Officer of Scale: "Meta's new investment and our broadened commercial agreement is a testament to the incredible work and dedication of the entire Scale team, and the tremendous upside that lies ahead for Scale. Scale has led the charge in accelerating AI development because we don't just adapt to change, we drive it. We have built the strongest foundation to tackle AI's data challenges and push the boundaries of what's possible. I'm dedicated to working with our talented team to continue realizing Alex's vision of bringing the benefits of AI to everyone. To our valued customers, we remain committed to partnering with you to build customized AI solutions that transform your organizations." About Jason Droege Jason Droege is a seasoned technology executive and entrepreneur. Before joining Scale, he was a Venture Partner at Benchmark, an investment firm focused on early-stage venture investing in consumer, marketplaces, open-source, AI, infrastructure, and enterprise software. He joined Benchmark in 2021 to collaborate closely with portfolio founders, leveraging his extensive experience in building consumer businesses. Prior to his role at Benchmark, Droege was a founder of Uber Eats, Uber's food delivery platform. Under his leadership as Vice President, Uber Eats grew from its first order in Toronto in December 2015 into one of the world's largest marketplaces with a $19 billion gross merchandise volume run rate globally at the time of his departure in 2020. Before his tenure at Uber, Droege played a pivotal role at Taser (now Axon Enterprise, Inc.), where he developed the Company's cloud strategy, transforming it from a hardware-focused business into a hybrid hardware and software company. He attended the University of California, Los Angeles (UCLA). Advisors Wilson Sonsini Goodrich & Rosati served as legal advisor to Scale and Centerview Partners LLC served as financial advisor. Joele Frank served as Scale's strategic communications advisor. About Scale AI Scale delivers high-quality data for AI development through our Data Foundry, and we provide technology solutions that enable our enterprise and public-sector customers to build, deploy, and oversee AI applications. By aligning AI with human values, we are accelerating progress while providing the necessary oversight to strengthen human sovereignty. Scale was founded in 2016 and is headquartered in San Francisco. View source version on Contacts Tom ChannickVP of Communicationspress@
Yahoo
43 minutes ago
- Yahoo
Brunswick Exploration Announces AGM Results
MONTREAL, June 12, 2025 (GLOBE NEWSWIRE) -- Brunswick Exploration Inc. ('BRW' or the 'Corporation') is pleased to announce the results of its annual general meeting ('AGM') of shareholders held on June 12, 2025. Shareholders holding a total of 80,309,202 common shares of the Corporation attended the AGM in person or were represented by proxy, representing approximately 37 % of the 218,274,932 common shares issued and outstanding. Pierre Colas, Jeffrey Hussey, André Le Bel, Amy Satov, Mathieu Savard and Robert Wares were re-elected to the board of directors. The shareholders also (i) approved the re-appointed Raymond Chabot Grant Thornton LLP as auditors for the ensuing financial year, (ii) approved the deferred share unit plan (the 'DSU Plan') adopted by the Corporation's board of directors on April 30, 2025, allowing for a maximum of 2,400,000 common shares to be awarded as deferred share units under the DSU Plan, and (iii) ratified, approved and confirmed the stock option plan, as amended by the Corporation's board of directors on April 30, 2025, allowing for a maximum of 19,400,000 common shares to be subject to stock options under the stock option plan. Collectively, the number of common shares reserved for issuance under all the Corporation's security-based compensation plans, namely the stock option plan and the DSU Plan, represents less than 10% of the Corporation's currently issued and outstanding common shares. The adoption of the DSU Plan and the amendment to the stock option plan remain subject to final approval by the TSX Venture Exchange. About Brunswick Exploration Brunswick Exploration is a Montreal-based mineral exploration company focused on grassroots exploration for lithium in Canada, a critical metal necessary to global decarbonization and energy transition. The Corporation is rapidly advancing the most extensive grassroots lithium property portfolio in Canada and Greenland. Investor Relations/information Mr. Killian Charles, President and Chief Executive Officer (info@ Cautionary Statement on Forward-Looking Information This news release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation based on expectations, estimates and projections as at the date of this news release. Forward-looking information involves risks, uncertainties and other factors that could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. Factors that could cause actual results to differ materially from such forward-looking information include, but are not limited to, delays in obtaining or failures to obtain required governmental, environmental or other project approvals; uncertainties relating to the availability and costs of financing needed in the future; changes in equity markets; inflation; fluctuations in commodity prices; delays in the development of projects; the other risks involved in the mineral exploration and development industry; and those risks set out in the Corporation's public documents filed on SEDAR+ at Although the Corporation believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Corporation disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news in to access your portfolio
