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
- Oct 29, 2026positive FDA confirmed that the BLA filing may proceed for rexlemestrocel-L for patients with life-threatening major gastrointestinal bleeding in end-stage heart failure with LVAD.
FDA confirmed the BLA filing may proceed for patients with life-threatening major gastrointestinal bleeding, a complication of the severe inflammation and vascular abnormalities in these patients.
Filing - Oct 29, 2026started The registration trial for expansion of Ryoncil use for adults with SR-aGvHD has commenced and is currently enrolling patients.
The registration trial for expansion of RYONCIL use for 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 - Oct 29, 2026n/a FDA confirmed that the BLA filing for rexlemestrocel-L may proceed for patients with life-threatening major gastrointestinal bleeding in end-stage heart failure with LVAD.
FDA confirmed the BLA filing may proceed for patients with life-threatening major gastrointestinal bleeding, a complication of the severe inflammation and vascular abnormalities in these patients.
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
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.