Mesoblast Ltd MESO
Mesoblast Ltd (Nasdaq: MESO) is a pain/anesthesia drug developer. Its lead program, rexlemestrocel-L, is in Phase 3 for chronic low back pain associated with degenerative disc disease.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ryoncil (remestemcel-L-rknd) | pediatric steroid-refractory acute GvHD (FDA approved, commercial since March 2025) | cell therapy | Approved |
| rexlemestrocel-L (MSB-DR004) | chronic low back pain / degenerative disc disease (pivotal Phase 3; patient treatment completed Aug 2026) | cell therapy | Phase 3 |
| rexlemestrocel-L | GI bleeding in end-stage heart failure patients with an LVAD (BLA filing number received, modular review requested June 2026) | cell therapy | Phase 3 |
| Ryoncil (remestemcel-L-rknd) | adult steroid-refractory acute GvHD, pivotal trial with BMT CTN planned | cell therapy | Phase 3 |
| Ryoncil (remestemcel-L-rknd) | Duchenne muscular dystrophy, IND cleared for registrational trial | cell therapy | Pre-clinical |
Recent results and decisions
- Sep 24, 2026n/a FDA approved a new potency assay (T-cell Proliferation Inhibition BioAssay, TIBA) for release and stability monitoring of all new commercial Ryoncil lots; a CMC change, not a new indication or product approval.
today announced that it has received approval from the United States Food and Drug Administration (FDA) to implement a new potency assay, T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of all new commercial product lots
Filing - Aug 26, 2026positive Previously presented (Tandem Meetings, February 2026) expanded-access data show 76% Day 100 survival in adolescents and adults treated with Ryoncil as third-line therapy, versus historical 20-30%.
showing 76% Day 100 survival in adolescents and adults treated with RYONCIL for third-line SR-aGvHD
Filing - Jul 29, 2026started Registration trial of Ryoncil for label extension in adults with SR-aGvHD has commenced and is enrolling, with up to 40 US sites expected to be activated this year.
The registration trial for label extension of Ryoncil® into adults with SR-aGvHD has commenced and is currently enrolling patients, with up to 40 sites across the U.S. expected to be activated this year
Filing
8 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 pain/anesthesia companies
- Not specified in extract Not specified in extract
- Scilex Holding Co SCLX
- Ensysce Biosciences, Inc. ENSC
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.