Welcome to our dedicated page for Mesoblast SEC filings (Ticker: MESO), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Mesoblast Limited (MESO) SEC filings page on Stock Titan provides access to the company’s U.S. regulatory disclosures as a foreign private issuer. Mesoblast files annual reports on Form 20-F and frequent Form 6-K reports that incorporate announcements made to the Australian Securities Exchange. These filings cover topics such as quarterly cash flow reports (Appendix 4C), new issue announcements (Appendix 3G), changes in directors’ interests (Appendix 3Y), and investor presentations.
For investors analyzing Mesoblast’s biotechnology business, the filings are a primary source of information on its allogeneic mesenchymal stromal cell platform, the commercial performance of Ryoncil for pediatric steroid-refractory acute graft versus host disease, and the development of product candidates like rexlemestrocel-L for chronic low back pain and heart failure. The company’s disclosures also describe its extensive intellectual property portfolio, proprietary manufacturing processes for cryopreserved off-the-shelf cellular medicines, and financing arrangements such as credit facilities and convertible notes.
Stock Titan enhances these documents with AI-powered summaries that highlight key points from long filings, helping readers quickly understand material changes, risk factor updates, and financing terms. Users can review real-time 6-K updates pulled from EDGAR, as well as annual 20-F reports that provide detailed discussion of Mesoblast’s operations, cell therapy pipeline, and risk profile.
In addition, this page offers convenient access to information related to equity issuance, corporate governance, and director transactions referenced in Mesoblast’s cross-filed ASX appendices. By combining original SEC documents with AI-generated overviews, the filings section helps investors, analysts, and researchers interpret Mesoblast’s regulatory reporting without reading every page line by line.
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.
Mesoblast Limited used its R&D Day to highlight rapid commercial progress with Ryoncil and a late‑stage pipeline targeting multi‑billion‑dollar inflammatory indications. Ryoncil net revenue is approaching US$100 million since its U.S. launch last year, with Q3 FY26 gross revenue of US$35 million and net revenue of US$30 million.
The company reported H1 FY26 Ryoncil gross profit of US$44 million against US$7 million in direct selling costs, and a cash balance of US$130 million at December 31 2025, supported by a new US$125 million term loan. Management targets FY26 net revenue of US$110–120 million and aims to double Ryoncil revenue.
Mesoblast is advancing Phase 3 programs for chronic low back pain and inflammatory heart failure, each with stated total addressable markets above US$10 billion, plus label extensions for Ryoncil in adult SR‑aGvHD and Duchenne muscular dystrophy. Next‑generation CAR‑ and oncolytic virus‑engineered MSC platforms and manufacturing upgrades are intended to support long‑term growth.
Mesoblast Limited reports that the U.S. FDA has granted Investigational New Drug (IND) clearance to proceed directly to a registrational clinical trial of Ryoncil (remestemcel-L-rknd) in Duchenne muscular dystrophy (DMD), a disease affecting about 15,000 children in the U.S.
The randomized trial will enroll 76 children aged 5 to 9 years to receive either Ryoncil or placebo on top of standard care, with seven infusions over nine months. The primary endpoint will be time-to-stand at nine months, an FDA-validated measure for approval.
Ryoncil, already FDA-approved for steroid-refractory acute graft-versus-host disease in pediatric patients, is being studied for its anti-inflammatory effects in DMD. Mesoblast is partnering with Parent Project Muscular Dystrophy to support patient identification and trial awareness.
Mesoblast Limited reports that Ryoncil® (remestemcel-L-rknd) generated net sales of US$30.3 million for the quarter ended March 31, 2026, marking a strong finish to Ryoncil’s first year on the market. February and March sales offset weaker, holiday-affected demand in January, and total Ryoncil® revenue since launch now approaches US$100 million, helping to strengthen the company’s balance sheet and fund label extension and late-stage programs.
Ryoncil® is described as the first mesenchymal stromal cell therapy approved by the U.S. FDA for any indication and the only FDA-approved treatment for children under 12 with steroid-refractory acute graft-versus-host disease. Mesoblast will present its Ryoncil® growth strategy and late-stage pipeline at an inaugural R&D Day in New York on April 8, 2026, alongside updates on its broader allogeneic cell therapy portfolio.
Mesoblast Limited submitted a Form 6-K as a foreign private issuer to provide U.S. investors with access to two Australian Securities Exchange filings. The report furnishes an April 7, 2026 Appendix 3B new issue announcement and an April 8, 2026 Appendix 2A application for quotation of securities as exhibits.
Mesoblast Ltd director William Murray Burns filed an initial Form 3 showing his beneficial holdings in the company. The filing lists several option awards over Ordinary Shares with exercise prices ranging from $0.36 to $1.81 per share and expirations between 2026 and 2031. It also reports direct ownership of 226,250 Ordinary Shares as of the reporting date. These entries reflect existing positions rather than new purchases or sales.
Mesoblast Ltd CEO and Managing Director Silviu Itescu reported his existing ownership of Ordinary Shares and stock options. He directly holds 67,756,838 Ordinary Shares and has additional indirect holdings through entities associated with him. He also holds multiple option awards over Ordinary Shares with exercise prices from 0.3500 to 2.4600 per share, expiring between 2026 and 2032.
Mesoblast Ltd CEO and Managing Director Silviu Itescu has filed an initial Form 3 detailing his beneficial ownership in the company. The filing lists substantial direct holdings of Mesoblast ordinary shares along with additional shares held indirectly through entities associated with him.
It also discloses multiple option awards over Mesoblast ordinary shares at exercise prices ranging from $0.01 to $3.39 per share, with expirations extending out to 2031. These options provide the right to acquire additional ordinary shares if exercised before their respective expiration dates.