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Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

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3 hours ago

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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 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 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. Release authorized by the Chief Executive. For more information, please contact:Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@

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4 hours ago

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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 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 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. Release authorized by the Chief Executive. For more information, please contact:Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

United States Presidential Culinary Museum® Celebrates America 250 with Launch of "The Washington's Famous Syllabub Drink"

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5 hours ago

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United States Presidential Culinary Museum® Celebrates America 250 with Launch of "The Washington's Famous Syllabub Drink"

GROVER, N.C., June 11, 2025 /PRNewswire/ -- In honor of the Semiquincentennial—America's 250th anniversary of independence—the United States Presidential Culinary Museum® is continuing to promote the national celebration with a unique culinary tribute: the Founding Families Syllabub, a fun, free-wheeling drink of the beloved Colonial-era libations. America's 250th anniversary is officially being marked by a year‑long series of national events, beginning Memorial Day 2025 and rocketing into July 4, 2026. With events spanning the federal government, local institutions, nonprofits, and the public, this multi-faceted celebration is meant to rekindle our country's rich history and spirit. Syllabub, a frothy, sweet drink traditionally made with cream, sugar, and wine or brandy, has a storied past dating back to the 1500s during the reign of the Tudors starting with King Henry VII, son of Edmund Tudor, 1st Earl of Richmond, and Lady Margaret Beaufort. It remained a favorite for more than 300 years. Long before eggnog with a dash of cinnamon became the seasonal staple, Syllabub was enjoyed year-round—both in England and in the American colonies. The drink's popularity grew immensely in the 1700s, despite sugar being heavily taxed and politically controversial for British colonists. In America, even amidst this taxation tension, Syllabub became a fashionable indulgence. By the time of the American Revolution, it had become a signature at social gatherings, particularly among Founding Fathers and First Lady Dolley Madison, who famously served it at White House receptions. Syllabub wasn't just a drink—it was an experience. It had its own glassware, utensils, and preparation techniques designed to create the perfect whipped froth on top. Initially served in clay mugs, its visual appeal led to the development of clear glass vessels, which triggered a consumer revolution of insanity purchasing. Middle-class households began purchasing specialty Syllabub sets, and merchants advertised entire fancy collections in their shops. During the Revolutionary War, the drink remained popular—even when fancy glassware was hard to come by. Colonists, considering themselves British Americans, were keen to keep pace with fashion trends from the U.K.—from food and drink to décor and dress. Owning Syllabub glassware was as much about identity as it was about indulgence. Today, the United States Presidential Culinary Museum® is proud to revive this historic beverage with an authentic, verified recipe from George and Martha Washington. Syllabub was famously served at the W Mount Vernon estate, Jefferson's Monticello, the Madison's Montpelier, according to historical records and is featured there today as well as at Williamsburg, The American Revolutionary War Living History Center, and Old Salem Village. Event Highlights: - Launch reception on July 4, 2025, at 3:00 PM in the Museum's Presidential Dining Room - Syllabub tasting stations, menu pairings, and live culinary demonstrations including non-alcoholic versions and how to create those - Historical talk series, "Sips from the Past: Colonial Drinks & Diplomacy" streamed on the PRESENTS™ Network via YouTube, Linkedin LIVE, Instagram, TWITCH, and Facebook Former White House Master Chef Marti Mongiello with his wife, Executive Chef Stormy Mongiello, Museum President, and Tournant Chef Barry Mongiello note: "Food—and drink—tell stories. Our syllabub bridges gastronomy and history, letting people taste, touch, and smell the touch of Colonial America. We're proud to be part of the nation's 250th celebrations." About the United States Presidential Culinary Museum® Located in Grover, NC., the town celebrates being named after President Grover Cleveland and is in Cleveland County, NC. It's dedicated to preserving and sharing the culinary traditions of America's presidents, first ladies, and their families. Through exhibitions, TV appearances, keynote speeches, White House replica luncheons and dinners, recipes, and tastings, it explores how food and drink reflect cultural and historical moments. Marti and Stormy Mongiello serve as the leading chefs, and both are disabled veterans of 36 years combined military service. Media Contact:Master Chef Marti Mongiello, MBA, MA, MCFEThe United States Presidential Culinary Museum® The US Presidential Service Center®301 Cleveland Ave, Grover, NC 28073 and (704) 937-2940ceo@ Historic Recipe: Washington Family Syllabub From the Kitchen of President George and Martha Washington. Perfected by Executive Chef to the Washington's, Hercules Posey – who later ran away from being a slave. Ingredients:- 1 Quart of heavy cream - 1 Cup of white wine- 6 Tablespoons white sugar - 1 whole nutmeg (grated) or ground nutmeg- 2 Tablespoons of rose water (can be bought or made with hot water and rose petals)- Zest of 1/2 lemon- Sprig of Rosemary- Salt (a pinch) Instructions from the manuscripts given by Franics Parke Custis to Martha Washington: Scald the cream together with the nutmeg, cut in quarters. Remove from the fire and when cool, pour in a glass jar. Let stand overnight. Mix the white wine, rose water, sugar, and a pinch of salt. Pour the cream over this and lay in the rosemary and lemon peel. Let stand for five or six hours until the curds form. The modern method: Pour cream into a bowl and beat with a whisk or electric mixer until soft peaks appear. Add the sugar, lemon zest, salt, rose water, nutmeg and beat briefly. Pour in the wine (experiment with sweet or dry wines, etc.) and mix then put into glasses and place into the refrigerator overnight to separate into cool layers. Decorate with more lemon zest and the sprigs of Rosemary. All types of other decorations can be fantasized about and made as well as adding even more whipped cream on top with grated nutmeg. Traditionally served in Syllabub glasses to show off the distinct layers, this recipe was a favorite of all of the revolutionary founding families and frequently offered at elegant affairs at the White House, private first family estates, on Presidential yachts and rail cars, and at the Camp David Resort and Conference Center. A "Whipt Syllabub" of the era would include many different flavor ideas of lemon and strawberry and other ideas and also could be made with egg whites and heavy cream mixed with sugar and wine beaten to a froth. View original content to download multimedia: SOURCE The US Presidential Culinary Museum Sign in to access your portfolio

Ketone Labs & Blue Pacific Flavors Announce Strategic Partnership to Drive Innovation in goBHB Powered Functional Beverages at Expo West 2025

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Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

United States Presidential Culinary Museum® Celebrates America 250 with Launch of "The Washington's Famous Syllabub Drink"

Ketone Labs & Blue Pacific Flavors Announce Strategic Partnership to Drive Innovation in goBHB Powered Functional Beverages at Expo West 2025

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Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

United States Presidential Culinary Museum® Celebrates America 250 with Launch of "The Washington's Famous Syllabub Drink"

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