Ann: Ryoncil Is Now Available For Purchase In The United States, page-154

Hi @HarveyM,

Agreed, they may not be the most proactive marketing company (especially for retail holders), however, below is just a sample of the news that I have seen and been released by a range of newsletters over the last 24 hrs (Motley Fool also had their say but I didnt bother including it).

NB: I haven’t copied every article (the links are there) but tried to pull out the ones that demonstrate some analysis (I hope the formatting stays it took forever ):

Stock Titan
"https://www.stocktitan.net/news/MESO/ryoncil-is-now-available-for-purchase-in-the-united-0jj0jcit2ddo.html"

Ryoncil® is Now Available for Purchase in the United States

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.

Positive

First FDA-approved MSC therapy now commercially available in USNine commercial payers covering 37M lives have approved favorable policiesSuccessful commercial launch within 3 months of FDA approvalPatient access hub established to facilitate insurance coverage
Negative
None.
Biotech Commercialization Analyst positiveMesoblast's announcement that Ryoncil® is now commercially available marks a pivotal transition from development-stage to commercial-stage company - a fundamental milestone in biotech evolution. The three-month timeline from FDA approval to market availability demonstrates efficient operational execution for a complex cell therapy product.

The commercial infrastructure appears well-established with the MyMesoblast™ patient access hub addressing critical reimbursement challenges typical of advanced therapies. The favorable coverage policies from nine commercial payers representing approximately 37 million covered lives indicates successful initial market access efforts, though this represents only a portion of the US insured population.

As the first FDA-approved mesenchymal stromal cell therapy for any indication, Ryoncil establishes Mesoblast's leadership in the cellular medicine space. While pediatric steroid-refractory acute GvHD represents a specialized market with patient numbers, successful commercialization validates the company's platform technology and manufacturing capabilities.

The pending Medicaid enrollment through the National Drug Rebate Agreement will expand access to additional patient populations. The lack of pricing details or revenue projections in this announcement is typical at this stage, with commercial performance metrics likely to emerge in future quarterly reports.

Healthcare Market Access Specialist positiveThe commercial launch of Ryoncil® represents significant progress in Mesoblast's reimbursement strategy. Securing favorable medical policies from nine commercial payers covering 37 million lives this early in the launch cycle suggests successful payer engagement, particularly noteworthy for a novel cell therapy where reimbursement hurdles are typically substantial.

The establishment of the MyMesoblast™ patient access hub indicates the company has implemented sophisticated patient support infrastructure - a critical success factor for specialized therapies with complex administration requirements. The hub's focus on insurance coverage assistance and financial support programs addresses the practical barriers that often limit uptake of advanced therapies.

The ongoing Medicaid enrollment process through the National Drug Rebate Agreement will be crucial for enabling access for economically disadvantaged patients. While the timeline is described only as "in short order," government program enrollment typically takes 1-2 quarters to fully implement.

For steroid-refractory acute GvHD patients who face high mortality rates, the availability of this therapy addresses a significant unmet medical need. The twice-weekly administration for four weeks represents a defined treatment course, which is favorable from both a clinical and reimbursement perspective compared to open-ended treatment regimens.

BioSpace

Ryoncil®is Now Available for Purchase in the United States

https://www.biospace.com/press-releases/ryoncil-is-now-available-for-purchase-in-the-united-states

BiotechDispatch

Mesoblastsays its FDA-approved mesenchymal stromal cell therapy available for sale inthe US

https://biotechdispatch.com.au/news/mesoblast-says-its-fda-approved-mesenchymal-stromal-cell-therapy-available-for-sale-in-the-us

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

MarketScreener

MesoblastLimited Announces That Ryoncil is Now Available for Purchase in the UnitedStates

https://www.marketscreener.com/quote/stock/MESOBLAST-LIMITED-6499027/news/Mesoblast-Limited-Announces-That-Ryoncil-is-Now-Available-for-Purchase-in-the-United-States-49453968/

Gurufocus

MesoblastLtd (MESO) Announces FDA Approval and U.S. Availability of Ryoncil® forPediatric SR-aGvHD

https://www.gurufocus.com/news/2752651/mesoblast-ltd-meso-announces-fda-approval-and-us-availability-of-ryoncil-for-pediatric-sragvhd

-
InnovativeMSC Therapy Now Accessible with Comprehensive Patient Support Programs

On March26, 2025, Mesoblast Ltd (MESO, Financial), a leader in allogeneic cellularmedicines for inflammatory diseases, announced the U.S. availability of Ryoncil®(remestemcel-L), the first FDA-approved mesenchymal stromal cell (MSC) therapyfor any indication. Ryoncil® is now available for pediatric patients withsteroid-refractory acute graft versus host disease (SR-aGvHD), a condition withhigh mortality rates. Mesoblast has also launched the MyMesoblast™ patientaccess hub to assist with insurance coverage and financial assistance.
-

PositiveAspects

Ryoncil®is the first FDA-approved MSC therapy, marking a significant milestone forMesoblast.

Thetherapy is available for pediatric patients, addressing a critical need forthose with SR-aGvHD.

Mesoblasthas established the MyMesoblast™ hub to ensure patient access and support.

Engagementwith insurers has resulted in favorable medical policies covering approximately37 million lives in the U.S.
-

NegativeAspects

Thetherapy's success depends on continued expansion of insurance coverage andreimbursement agreements.

Potentialrisks include regulatory challenges and market acceptance of stem-cell basedtherapies.

FinancialAnalyst Perspective

From a financial standpoint, the FDAapproval and subsequent U.S. launch of Ryoncil® represent a pivotal moment forMesoblast Ltd (MESO, Financial). The company's strategic engagement withinsurers and the establishment of the MyMesoblast™ hub are likely to facilitatemarket penetration and revenue generation. However, the financial success will depend on thecompany's ability to expand insurance coverage and manage the costs associatedwith manufacturing and distribution. The potential for additional indicationsand partnerships in global markets could further enhance revenue streams.
-

MarketResearch Analyst Perspective

As a market research analyst, theintroduction of Ryoncil® into the U.S. market is a significant development inthe field of cellular medicines. The approval of the first MSC therapy by theFDA sets a precedent and could influence the regulatory landscape for similartherapies. The focus on pediatric SR-aGvHD addresses a niche but criticalmarket, and the success of Ryoncil® could pave the way for broader applicationsof MSC therapies. The company's proactive approach in securing insurancecoverage and establishing patient support programs is likely to enhance marketacceptance and adoption