Mesoblast - MESO STOCK NEWS

Mesoblast (MESO) has expanded insurance coverage for its FDA-approved therapy Ryoncil® (remestemcel-L) to reach over 104 million US lives. The coverage includes both government and commercial payers.

The therapy, which is the first mesenchymal stromal cell (MSC) treatment approved by the FDA, has achieved significant coverage milestones:

• 37 out of 51 states now provide fee-for-service Medicaid coverage through Orphan Drug Lists or medical exception/prior authorization process, covering 20 million lives (80% of total Medicaid fee-for-service lives)
• Remaining states will implement mandatory coverage for 24 million lives by July 1, 2025
• Commercial plans and managed Medicaid have established policies covering 84 million lives

Additional coverage through Medical Exceptions policies exists but is not included in these figures, suggesting the total coverage is higher than reported.

Mesoblast (Nasdaq:MESO) announced that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to U.S. tariffs as they are designated as 'U.S. Country of Origin' products. The company's products are manufactured from U.S. donors within the United States.

Ryoncil® holds the distinction of being the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication. It is specifically approved for treating pediatric patients 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD), a high-mortality condition.

Mesoblast (MESO) has filed a request for a Type B meeting with the FDA to discuss the accelerated approval pathway for Revascor® in treating ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. The meeting, expected this quarter, will be held under Mesoblast's Regenerative Medicines Advanced Therapy (RMAT) designation.

In a previous Type B meeting, the FDA indicated Mesoblast's eligibility to file for accelerated approval for Revascor in end-stage HFrEF patients, based on data from two randomized controlled trials. The FDA also specified the requirement for a single confirmatory trial in class II/III patients with ischemic HFrEF and inflammation post-approval.

The upcoming meeting aims to obtain FDA feedback on chemistry, manufacturing & controls (CMC), align on potency assays for commercial product release, and discuss the proposed design and primary endpoint for the confirmatory trial.

Mesoblast (MESO) has entered into the Medicaid National Drug Rebate Agreement with U.S. Centers for Medicare & Medicaid Services for Ryoncil®, the first FDA-approved mesenchymal stromal cell therapy. This agreement ensures treatment access for approximately 40% of U.S. children covered by Medicaid who have steroid-refractory acute graft versus host disease (SR-aGvHD), with the remaining coverage through private insurance.

States can immediately opt to cover Ryoncil®, with mandatory coverage starting July 1, 2025. The first three children with SR-aGvHD will begin treatment this week. Ryoncil® is approved for pediatric patients 2 months and older, with a recommended course of 2×106 MSC/kg body weight per intravenous infusion, administered twice weekly for 4 consecutive weeks.

Mesoblast (MESO) has announced that Ryoncil® (remestemcel-L), the first FDA-approved mesenchymal stromal cell (MSC) therapy, is now commercially available in the United States. The therapy is approved for treating pediatric patients aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD).

The recommended dosage is 2×106 MSC/kg body weight per intravenous infusion, administered twice weekly for 4 weeks. Mesoblast has established MyMesoblast™, a patient access hub, to facilitate insurance coverage and financial assistance. Nine commercial payers, covering approximately 37 million lives in the US, have published favorable medical policies. The company is also in process of entering the National Drug Rebate Agreement with Medicaid.

Mesoblast (Nasdaq:MESO; ASX:MSB) announced that pricing information for Ryoncil® is now accessible in all four major U.S. drug pricing compendia. This development follows the FDA's approval and publication of the revised Ryoncil® label, specifically updating Section 16 regarding supply and handling information.

The update includes the approval of eight new Ryoncil® kits, each with unique National Drug Codes (NDC), designed to match product dosage with patient weight-bands. Treatment centers can now order weight-appropriate kits with uniform pricing regardless of patient weight. The four major compendia are Merative Micromedex® RED BOOK®, First Databank FDB MedKnowledge® Drug Pricing, Elsevier Gold Standard Drug Database, and Wolters Kluwer Medi-Span® Price Rx®.

Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, announced that CEO Silviu Itescu will deliver the Featured Presentation at the International Cell & Gene Therapy (ISCT) North America Regional Virtual Town Hall. The presentation, titled 'Ryoncil® - The First FDA Approved Mesenchymal Stromal Cell Therapy,' will take place on March 12, 2025, at 4:00pm EDT (March 13th, 7:00am AEDT).

Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has been added to the S&P/ASX 200 Index effective March 6, 2025.

The S&P/ASX 200 Index is Australia's premier benchmark index, designed to track the performance of the 200 largest index-eligible stocks listed on the Australian Stock Exchange (ASX) by float-adjusted market capitalization. This widely recognized index serves as the institutional investable benchmark in Australia, known for its representative, liquid, and tradable characteristics.

Mesoblast (NASDAQ:MESO) has announced the pricing and upcoming availability of its FDA-approved product Ryoncil® for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. The wholesale acquisition cost is set at US$194,000 per infusion.

The company reported that Ryoncil® demonstrated a 70% overall response rate in Phase 3 trials, with 49% survival through 4 years. The treatment's total benefits range from US$3.2-4.1 million per patient. Mesoblast has established MyMesoblast™ hub for patient services and partnered with Cencora for distribution.

Financial highlights include a cash balance of US$38 million as of December 31, 2024, with pro-forma cash of approximately US$200 million after completing a US$161 million global private placement. The company reported a net loss of US$47.9 million for H1 FY2025, with net operating cash spend reduced by 22% to US$20.7 million compared to H1 FY2024.