Mesoblast Updates On Rexlemestrocel-L Program In Chronic Low Back Pain

Mesoblast Limited MESO provided an update on the strategy for bringing rexlemestrocel-L to patients in the U.S. with chronic low back pain (CLBP) due to degenerative disc disease refractory to available therapies.
The company has filed a request and expects to hold a Type C meeting with the FDA during the current quarter to discuss the pathway to U.S. regulatory approval for rexlemestrocel-L following the recently completed Phase 3 trial.
It plans to use the results from a planned U.S. trial to support potential approvals in both U.S. and E.U. by including 20% E.U. patients to provide regulatory harmonization, cost efficiencies, and streamlined timelines without initiating an E.U. trial.
In line with this strategy, Mesoblast and its partner Grünenthal have amended their collaboration agreement, with Mesoblast eligible to receive payments up to $112.5 million before the product launch in the E.U., inclusive of US$17.5 million already received.
Cumulative milestone payments could reach $1 billion.
Price Action: MESO shares are trading higher by 15% at $8.60 in the premarket session on the last check Thursday.