Mesoblast Updates On Rexlemestrocel-L Program In Chronic Low Back Pain
- Mesoblast Limited (NASDAQ: 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.
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