Phase 3Data readout

Rexlemestrocel

Chronic lower back pain (CLBP)

MESOMesoblast

Expected catalystAugust 15, 2027Company guidance: Aug 15, 2027

Catalyst overview

Event details

Drug or asset: Rexlemestrocel
Development stage: Phase 3
Event type: Data readout
Indication: Chronic lower back pain (CLBP)

Research summary

What is being tracked?

This catalyst tracks a Phase 3 data readout for Rexlemestrocel in Chronic lower back pain (CLBP). The expected timing is based on the latest available company guidance and may change.

Development notes

4/29/24 - Second Ph 3 study ongoing. 8/29/24- Received RMAT designation. 1/30/25- Upcoming Ph3 completion & BLA submission. 11/4/25– FDA meeting in December. 01/18/26:- FDA Type B feedback supports 12-month pain endpoint; Ph3 MSB-DR004 enrollment completion expected April 2026. 02/20/26:- PR No update. 04/28/26:- Recruitment complete in MSB-DR004; topline results expected Mid-2027; filing expected Q3 2027. 04/29/26:- Ph3 CLBP trial met recruitment target; topline data and BLA timeline unchanged. 07/13/26:- Treated 300+ pts in MSB-DR004 Ph3; topline results still expected Mid-2027. 07/29/26:- MSB-DR004 Ph3 reached 300 treated patients. Mid-2027 topline timing remains unchanged. 08/16/26:- Completed MSB-DR004 Ph3 treatment (350 pts); topline results still expected Mid-2027.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

What is being tracked?

This catalyst tracks a Phase 3 data readout for Rexlemestrocel in Chronic lower back pain (CLBP). The expected timing is based on the latest available company guidance and may change.