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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.
Mesoblast Limited furnished a Form 6-K summarizing Australian Securities Exchange disclosures about director equity awards and other unquoted securities. The filing attaches Appendix 3Y notices showing option grants, with no cash consideration, to multiple directors following shareholder approval at the 2025 annual general meeting.
Chief Executive Officer Dr Silviu Itescu received 2,025,600 new options, increasing his option holdings to 18,475,158 while his 78,958,928 ordinary shares were unchanged. Director Dr Eric Rose received 820,000 options, bringing his total to 6,413,451 options with 6,749,274 ordinary shares unchanged. Director Gregory George received 200,000 options to acquire ordinary shares under the employee share option plan. Director Lyn Cobley received 200,000 options, adding to her existing direct and indirect shareholdings. The 6-K also forwards an Appendix 3G notice on unquoted equity securities.
Mesoblast Ltd director Philip R. Krause has filed an initial ownership report showing his equity position in the company. He directly holds 287,500 Ordinary Shares, which are represented by American Depositary Shares. In addition, he holds multiple option awards over Ordinary Shares with exercise prices between $0.32 and $0.99 per share and expirations ranging from 2029 to 2031. Footnotes indicate that certain options were granted in 2023 and 2024 and are scheduled to vest between October 24, 2026 and August 27, 2027, aligning his compensation with the company’s long-term performance.
Mesoblast Limited has filed a Form 6-K highlighting plans for its inaugural R&D Day on April 8, 2026, in New York City. The event will run from 8:00am to 11:00am EST and be webcast live for global access.
Senior leadership and external experts will present on corporate strategy, commercialization of flagship product Ryoncil®, and multi-billion-dollar pipeline opportunities in inflammatory pain and cardiovascular disease. Mesoblast will also unveil new technology intended to support the next era of cellular medicines.
The disclosure reiterates that Mesoblast develops allogeneic cellular therapies for severe inflammatory conditions, including FDA-approved Ryoncil® for pediatric steroid-refractory acute graft versus host disease, and is advancing remestemcel-L and rexlemestrocel-L programs with global partnerships, extensive patents, and proprietary large-scale manufacturing.