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MESOBLAST (MESO)

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Recent press releases and 8-K filings for MESO.

Mesoblast Reports Strong Ryoncil Sales and Secures New Financing in Q2 2026
MESO
Earnings
Debt Issuance
New Projects/Investments
  • Mesoblast Limited reported Ryoncil® net revenues of US$30 million for the quarter ended December 31, 2025, with gross sales increasing 60% to US$35 million compared to the prior quarter.
  • The company secured a new US$125 million non-dilutive credit-line at a fixed interest rate of 8.00% per annum, with US$75 million initially drawn, and held US$130 million in cash at December 31, 2025.
  • Net operating cash spend for the quarter was US$16 million, and the company estimates 11.6 quarters of funding available based on current cash and unused facilities.
  • Mesoblast received positive FDA feedback on a potential Biologics License Application (BLA) filing for rexlemestrocel-L in chronic discogenic low back pain and expects to commence a pivotal trial for Ryoncil® in adults with severe SR-aGvHD this quarter.
Jan 29, 2026, 1:17 PM
Mesoblast Reports Strong Real-World Survival Data for Ryoncil® in Pediatric SR-aGvHD
MESO
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Mesoblast Limited reported 84% survival (21 out of 25 patients) in children with steroid-refractory acute graft-versus-host disease (SR-aGvHD) after completing the initial 28-day treatment regimen with Ryoncil® (remestemcel-L-rknd) since its commercial availability in March 2025.
  • Ryoncil® is available through 45 onboarded transplant centers and is covered by government and commercial payers for over 260 million U.S. lives.
  • The issuance of a specific HCPCS J-Code on October 1, 2025, for billing and reimbursement resulted in greater usage of Ryoncil® under CMS coverage in the last quarter.
  • The company plans to expand the FDA label for Ryoncil® to adults with severe SR-aGvHD, a market approximately three times larger than the pediatric population, with a pivotal trial expected to commence site enrollment this quarter (Q2 2026).
Jan 28, 2026, 8:26 PM
Mesoblast Receives Positive FDA Feedback on Rexlemestrocel-L for Chronic Low Back Pain
MESO
Product Launch
New Projects/Investments
  • The FDA acknowledged that the effects on pain intensity favor Mesoblast's rexlemestrocel-L and confirmed that a clinically meaningful reduction in pain intensity at 12 months can support product efficacy for chronic discogenic low back pain (CLBP).
  • The FDA also stated that robust results on opioid reduction from an adequate and well-controlled trial could be included in the Clinical Studies section of the product labeling for rexlemestrocel-L.
  • Mesoblast's second randomized controlled Phase 3 trial (MSB-DR004) for rexlemestrocel-L is over 50% enrolled and is expected to complete its 300-patient enrollment target within the next three months.
Jan 20, 2026, 10:42 PM
Mesoblast Reports Strong Ryoncil Sales Growth and New Financing Facility
MESO
Earnings
Revenue Acceleration/Inflection
Debt Issuance
  • Mesoblast Limited announced gross revenue of US$35.1 million from Ryoncil® sales for the quarter ended December 31, 2025.
  • This represents a 60% increase in Ryoncil® sales compared to the prior quarter ended September 30, 2025.
  • The company secured a new US$125 million five-year interest-only facility, which allowed for the full repayment of its prior senior secured loan and partial repayment of its subordinated royalty facility.
  • The new financing facility offers a substantially lower overall cost and provides greater flexibility for strategic partnerships and commercialization.
  • Ryoncil®, the first FDA-approved mesenchymal stromal cell product, will be evaluated in a pivotal trial for adults with steroid-refractory acute graft-versus-host disease (SR-aGvHD), a market approximately three times larger than the pediatric market.
Jan 9, 2026, 12:59 AM
Mesoblast refinances debt with new credit facility
MESO
Debt Issuance
  • Mesoblast Limited repaid its existing senior secured loan and partially repaid its subordinated royalty facility by drawing US$75 million from a new five-year credit facility.
  • The new facility, provided by an existing shareholder and director, features a fixed interest rate of 8.00% per annum, a substantial reduction from previous debt facilities, and includes a five-year interest-only period.
  • An additional US$50 million can be drawn by Mesoblast until June 30, 2026, and the facility does not encumber any material assets or intellectual property, providing greater financial flexibility.
  • In connection with the facility, the provider will receive 5-year warrants to purchase approximately 323,000 American Depositary Shares (ADSs) at US$21.51 per ADS, subject to shareholder approval by November 30, 2026.
Dec 30, 2025, 12:10 AM
Mesoblast Issues Warrants as Commitment Fee for Convertible Note Facility
MESO
Debt Issuance
  • Mesoblast Limited issued 5,000,000 unquoted WARRANTS 3 on December 17, 2025.
  • These warrants were issued as a commitment fee for an up to US$50 million convertible note facility.
  • The warrants have an exercise price of AUD 2.50 and an expiry date of December 17, 2029.
  • 3 million of these warrants will only vest and become exercisable if the company exercises its option under the convertible note facility.
Dec 18, 2025, 2:58 AM
Mesoblast's Remestemcel-L Shows Superior Outcomes in SR-aGvHD Treatment Study
MESO
New Projects/Investments
  • An independent meta-analysis presented at the 67th ASH Annual Meeting concluded that Mesoblast's remestemcel-L demonstrated superior outcomes in complete and overall remission compared to ruxolitinib for treating steroid-refractory acute graft versus host disease (SR-aGvHD).
  • The study involved 2,732 patients, with 644 receiving remestemcel-L and 1,349 receiving ruxolitinib across 11 studies.
  • Mesoblast's Ryoncil® (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell (MSC) product and the only one approved for children under age 12 with SR-aGvHD.
  • The company holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection through to at least 2044.
Dec 12, 2025, 1:09 AM
Mesoblast Reports Strong Ryoncil Launch and Outlines Pipeline Progress
MESO
Product Launch
Guidance Update
New Projects/Investments
  • Mesoblast's Ryoncil for pediatric acute acute graft-versus-host disease (aGVHD) achieved $30 million in net sales in the first two quarters of 2025, with current quarter (Q4 2025) sales projected to be greater than $30 million.
  • The company plans to expand Ryoncil into the adult aGVHD market, which is three times larger than the pediatric market, with a potential 2027 filing for label extension following a planned 12-month enrollment for a randomized controlled trial.
  • Mesoblast anticipates filing a Biologics License Application (BLA) for Revascor in heart failure patients with a left ventricular assist device (LVAD) in the first quarter of 2026.
  • A second trial for Revascor in chronic lower back pain is ongoing, with enrollment expected to complete in the first quarter of 2026 and a 12-month readout, showing potential for opioid avoidance.
  • The company reported approximately $146 million in cash at the end of Q3 2025 and anticipates potentially reaching break-even by mid-2026.
Dec 4, 2025, 5:00 PM
Mesoblast Provides Updates on Ryoncil Launch, Revascor Filings, and Financial Outlook
MESO
Product Launch
Guidance Update
New Projects/Investments
  • Mesoblast reported net sales of $30 million for Ryoncil in the first two quarters and expects over $30 million in the current quarter, indicating a strong launch in pediatric acute graft-versus-host disease (aGVHD).
  • For Ryoncil's adult aGVHD indication, a randomized controlled trial is planned, with enrollment expected to take 12 months and a 2027 filing targeted for potential label extension.
  • The company anticipates filing a Biologics License Application (BLA) for Revascor in heart failure patients with a left ventricular assist device (LVAD) in Q1 2026.
  • Enrollment for a confirmatory Phase III trial of rexlemestrocel-L (Revascor) for chronic lower back pain is projected to complete in Q1 2026, with a 12-month readout.
  • Mesoblast reported approximately $146 million in cash at the end of the last quarter and aims to potentially reach break-even by mid-2026.
Dec 4, 2025, 5:00 PM
Mesoblast Provides Update on Product Launches, Pipeline, and Financials
MESO
Product Launch
Guidance Update
New Projects/Investments
  • Mesoblast's Ryoncil for pediatric acute aGVHD has achieved $30 million in net sales over the first two quarters, with the current quarter (Q4 2025) projected to exceed $30 million.
  • The company plans to file a Biologics License Application (BLA) for Revascor in heart failure patients with a left ventricular assist device (VAD) in the first quarter of 2026.
  • A randomized controlled trial for Ryoncil in adult steroid-refractory acute graft-versus-host disease is commencing, targeting a 2027 filing for label expansion.
  • Mesoblast reported approximately $146 million in cash at the end of Q3 2025 and anticipates potentially reaching break-even by mid-2026.
Dec 4, 2025, 5:00 PM