Allogeneic cell therapy for inflammatory conditions, Ryoncil approved in Japan
Peer-reviewed papers & conference abstracts via PubMed
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These changes were automatically detected by comparing ClinicalTrials.gov records over time. A slipped date means the trial's expected completion moved later; pulled forward means it moved earlier.
| Event | Type | Confidence | Impact | Date | Status |
|---|---|---|---|---|---|
| Remestemcel-L US BLA resubmission pathway Working with FDA on pathway for US approval in SR-aGvHD | regulatory decision | Expected | arrow_upwardHigh | 30 June 2026 | Upcoming |
| CHF Phase 3 interim data Rexlemestrocel-L in chronic heart failure, interim data expected | data readout | Expected | arrow_upwardHigh | 30 Sept 2026 | Upcoming |
| Ryoncil® (remestemcel-L-rknd) FDA — Mesoblast R&D Day Features Commercial & Blockbuster Programsopen_in_new The FDA cleared an IND for Ryoncil® to directly proceed to a registrational trial for approval in children with Duchenne muscular dystrophy (DMD). This represents a label extension strategy beyond Ryoncil's existing approval for pediatric SR-aGvHD. | regulatory decision | Confirmed | removeMed | 8 Apr 2026 | Completed |
| Ryoncil (remestemcel-L-rknd) FDA — FDA Clears Ryoncil IND for Registration Trial in DMDopen_in_new The FDA granted IND clearance for Ryoncil to proceed directly to a registrational clinical trial in Duchenne Muscular Dystrophy, evaluating the drug's anti-inflammatory mechanism in children aged 5 to 9 years. The trial will randomize 76 patients with a primary endpoint of time-to-stand at nine months, a validated FDA approval endpoint. | regulatory decision | Confirmed | removeMed | 8 Apr 2026 | Completed |
| Ryoncil (remestemcel-L-rknd) FDA — FDA Clears Ryoncil IND for Registration Trial in DMDopen_in_new The FDA granted IND clearance for Ryoncil to proceed directly to a registrational clinical trial in Duchenne muscular dystrophy, bypassing earlier phase trials. The trial will randomize 76 patients aged 5-9 years to evaluate Ryoncil's anti-inflammatory mechanism as a potential treatment to preserve muscle function and slow disease progression in DMD. | regulatory decision | Confirmed | removeMed | 8 Apr 2026 | Completed |
| Results posted — Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L)open_in_new Results available at https://clinicaltrials.gov/study/NCT02032004 | data readout | Confirmed | arrow_upwardHigh | 8 Apr 2026 | Completed |
| Results posted — Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infopen_in_new Results available at https://clinicaltrials.gov/study/NCT01781390 | data readout | Confirmed | arrow_upwardHigh | 8 Apr 2026 | Completed |
| Results posted — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaopen_in_new Results available at https://clinicaltrials.gov/study/NCT02412735 | data readout | Confirmed | arrow_upwardHigh | 8 Apr 2026 | Completed |
| Results posted — A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Sopen_in_new Results available at https://clinicaltrials.gov/study/NCT02336230 | data readout | Confirmed | arrow_upwardHigh | 8 Apr 2026 | Completed |
| Results posted — Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Hopen_in_new Results available at https://clinicaltrials.gov/study/NCT02652130 | data readout | Confirmed | arrow_upwardHigh | 8 Apr 2026 | Completed |
| Ryoncil (remestemcel-L) FDA — Mesoblast R&D Day Presentationopen_in_new Ryoncil (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy, successfully launched in the US for pediatric SR-aGvHD. Net revenue has approached US$100 million since launch, with the company now investing proceeds into label extension studies and blockbuster pipeline opportunities. | regulatory decision | Confirmed | removeMed | 8 Apr 2026 | Completed |
| Ryoncil® (remestemcel-L-rknd) FDA — Mesoblast R&D Day Features Commercial & Blockbuster Programsopen_in_new The FDA cleared an IND allowing Mesoblast to directly proceed to a registrational trial for approval of Ryoncil® in children with Duchenne muscular dystrophy (DMD). This represents a label extension strategy beyond Ryoncil's existing approval for pediatric steroid-refractory acute graft versus host disease. | regulatory decision | Confirmed | removeMed | 8 Apr 2026 | Completed |
| Ryoncil (remestemcel-L) FDA — Mesoblast R&D Day Presentationopen_in_new Ryoncil (remestemcel-L) received FDA approval as the first approved mesenchymal stromal cell therapy, and has been successfully launched in the US with net revenue approaching US$100 million since launch. The company is now pursuing label extensions including adult SR-aGvHD and pediatric rare diseases such as Duchenne Muscular Dystrophy. | regulatory decision | Confirmed | removeMed | 8 Apr 2026 | Completed |
| Results posted — Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L)open_in_new Results available at https://clinicaltrials.gov/study/NCT02032004 | data readout | Confirmed | arrow_upwardHigh | 13 Apr 2026 | Completed |
| Results posted — A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Sopen_in_new Results available at https://clinicaltrials.gov/study/NCT02336230 | data readout | Confirmed | arrow_upwardHigh | 13 Apr 2026 | Completed |
| Results posted — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaopen_in_new Results available at https://clinicaltrials.gov/study/NCT02412735 | data readout | Confirmed | arrow_upwardHigh | 13 Apr 2026 | Completed |
| Results posted — Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Hopen_in_new Results available at https://clinicaltrials.gov/study/NCT02652130 | data readout | Confirmed | arrow_upwardHigh | 13 Apr 2026 | Completed |
| Results posted — Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infopen_in_new Results available at https://clinicaltrials.gov/study/NCT01781390 | data readout | Confirmed | arrow_upwardHigh | 13 Apr 2026 | Completed |