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Mesoblast Limited reported preliminary net revenue from Ryoncil® (remestemcel-L-rknd) of US$36 million for the fourth quarter and US$115 million for the first full year ended June 30, 2026. Management highlights strong uptake since launch and states that revenues have already exceeded initial projections.
The company expects continued revenue growth in the coming fiscal year, citing momentum across major U.S. pediatric centers, and describes its capital position as strong with operational activities well funded through revenue growth and a new five-year facility. Ryoncil® is described as the first FDA-approved mesenchymal stromal cell therapy and the only approved product for children under 12 with steroid-refractory acute graft-versus-host disease. The revenue figures are based on preliminary estimates and remain subject to customary year-end closing and audit procedures.
Mesoblast Limited reports a key regulatory step for its investigational cell therapy rexlemestrocel-L in end-stage heart failure patients supported by left ventricular assist devices (LVADs). The company has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration and has requested a modular review of the BLA for preventing life-threatening gastrointestinal bleeding linked to right ventricular dysfunction.
Rexlemestrocel-L, an allogeneic mesenchymal precursor cell therapy, holds both Regenerative Medicine Advanced Therapy and Orphan Drug designations in this LVAD population, potentially allowing rolling and priority review. Mesoblast highlights recent FDA draft guidance emphasizing regulatory flexibility for serious rare diseases, while positioning rexlemestrocel-L within a broader pipeline that includes the already FDA-approved Ryoncil for pediatric steroid-refractory acute graft versus host disease.
Mesoblast Limited has drawn down US$50 million from a five-year, non-dilutive credit facility provided by existing shareholder and director Dr. Gregory George. Together with US$122 million of cash as of March 30, 2026, this strengthens funding for commercial operations and its growth pipeline.
The new facility carries a fixed interest rate of 8.00% per annum with a five-year interest-only period and can be repaid at any time without prepayment or exit fees. It is secured solely by the Temcell royalty, leaving Mesoblast’s other material assets and intellectual property unencumbered.
Mesoblast Limited highlights progress as a global leader in allogeneic, off‑the‑shelf cellular medicines. Its first FDA‑approved product RYONCIL has generated net revenue exceeding US$100M since launch, with Q3 FY26 gross revenue of US$35M and net revenue of US$30M.
RYONCIL produced gross profit of US$44M in 1H FY26, against direct selling costs of US$7M. Net operating cash spend in Q3 FY26 was US$4M, supported by receipts of US$34.6M, and cash was US$122M at March 31, 2026. A new US$125M term loan replaces higher‑cost debt.
The company is funding an extensive pipeline, including Phase 3 programs for chronic low back pain and chronic heart failure using rexlemestrocel‑L, and label‑extension studies for RYONCIL in adult steroid‑refractory acute graft versus host disease and pediatric Duchenne muscular dystrophy. Mesoblast is also advancing next‑generation gene‑modified MSC platforms such as CAR‑MSCs and OV‑MSCs for new indications.
Mesoblast Limited reported strong progress for the quarter ended March 31, 2026. Lead product Ryoncil® generated gross sales of US$35.3 million and net revenues of US$30.3 million, with first-year launch revenues approaching US$100 million. Net operating cash spend was reduced to US$4.1 million, supported by customer receipts of US$34.6 million and tight cost control.
The company ended the quarter with US$121.8 million in cash and cash equivalents and reported total available funding of US$171.8 million, equivalent to an estimated 41.8 quarters of funding at the current cash burn rate. Mesoblast achieved its patient recruitment target in a pivotal phase 3 trial of rexlemestrocel‑L for chronic low back pain and received FDA clearance to begin a label‑extension trial of Ryoncil in adults with steroid‑refractory acute graft versus host disease, as well as IND clearance for a registrational trial in Duchenne muscular dystrophy. The company also acquired an exclusive worldwide license to a patented CAR technology platform to develop next‑generation mesenchymal stromal cell products for inflammatory and autoimmune diseases.
Mesoblast Ltd director Lynette Elizabeth Cobley filed an initial Form 3 showing her existing equity stake. She reports 30,000 Ordinary Shares held directly and 33,000 Ordinary Shares held indirectly through Synergy Finance Pty Ltd as trustee for her self-managed superannuation fund. She also holds an option over 200,000 Ordinary Shares at an exercise price of $1.72 per share, expiring on May 9, 2032. According to the footnote, these options were granted on May 10, 2025 and vest in three annual tranches through 2028.
Mesoblast Limited reported that its pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease has reached its patient recruitment target of at least 300 participants. Patients receive a single intra-discal injection of rexlemestrocel-L or sham control and are followed for 12 months.
The study aims to confirm earlier Phase 3 results that showed clinically meaningful pain and opioid-use reductions for up to three years. Top-line data are expected in mid-CY2027, with a planned U.S. FDA Biologics License Application filing in Q3 CY2027. Rexlemestrocel-L holds Regenerative Medicine Advanced Therapy designation, and Mesoblast sees potential peak year revenue above US$10 billion at single-digit market penetration, given over 7 million affected patients in the U.S.
Mesoblast Limited furnished a Form 6-K that forwards several Australian Securities Exchange appendices on new equity issues and changes in securities, including a detailed change of director’s interest notice for Gregory George.
The notice shows an increase in his indirect holdings after on-market purchases by related holders. These trades added 70,000 American Depositary Shares (ADS), with each ADS representing 10 ordinary shares, and 7,210,962 ordinary shares. The filing states total cash consideration of US$11,429,969.84 for the ADS and ordinary shares purchased. Following the transactions, his indirect interests rose to 12,855,154 ordinary shares, 14,485,410 ADS, and 6,830,602 warrants to acquire ordinary shares, while his direct positions were unchanged.
Mesoblast Ltd director and ten percent owner George Gregory reported a series of indirect open-market purchases of Ordinary Shares. Between April 4 and April 10, related accounts for Grant George and James George, each granting power of attorney to Dr. George, bought a combined 7,910,962 Ordinary Shares at prices between $1.41 and $1.48 per share. The filing shows indirect holdings in these accounts increasing to as many as 13,586,890 Ordinary Shares following the transactions. A footnote explains that these Ordinary Shares are represented by American Depositary Shares, with each ADS reflecting a beneficial interest in 10 Ordinary Shares, and that reported prices are already adjusted to the per‑Ordinary‑Share level.
Mesoblast Ltd director and 10% owner George Gregory, through accounts held by Grant George and James George over which he has power of attorney, reported open-market purchases totalling 8,305,962 Ordinary Shares of Mesoblast.
Individual transactions on April 4, April 9 and April 10, 2026 ranged from 4,000,000 shares at $1.42 per share to smaller blocks around $14.10–$14.40 per share. Following these purchases, the reported indirect holdings in the various accounts increased, with the largest shown position reaching 13,586,890 Ordinary Shares. The Ordinary Shares are represented by American Depositary Shares, with each ADS corresponding to a beneficial interest in 10 Ordinary Shares.