Jan. 21 at 12:19 AM
$MESO$XBI BREAKING: Mesoblast (
$MESO) just secured a vital regulatory win for its Stem Cell therapy (rexlemestrocel-L).
The FDA confirmed the path to approval for Chronic Low Back Pain (CLBP)—a market of 7 million US patients.
The Alpha: • Primary Endpoint: FDA accepted 12-month pain reduction as the bar for approval. • Label Upside: FDA is open to including "Opioid Reduction" claims. Data shows patients were 3x more likely to quit opioids completely vs placebo.
This positions
$MESO not just as a pain play, but as a regenerative solution to the Opioid Crisis. Confirmatory Phase 3 is >50% enrolled.
