Mesoblast (NASDAQ: MESO) shares are climbing premarket on Monday after the company released clinical trial results for its drug rexlemestrocel-L, showing promising signs.
Mesoblast’s US-listed shares are up 77.48% at $15.37 after its Australian-listed shares closed 14.29%.
The results from the DREAM-HF randomised controlled Phase 3 trial showed that a single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. The trial enrolled 537 treated patients with chronic heart failure and reduced left ventricular ejection fraction.
Since existing therapies have minimal or no benefit on these endpoints, Mesoblast feels the outcomes may signal a breakthrough in addressing the unmet needs in patients with chronic heart failure.
Heart attacks and strokes were reduced by 60% over an average follow-up period of 30 months following a single dose of rexlemestrocel-L in the group of 537 patients with New York Heart Association class II or III chronic heart failure.
Rexlemestrocel-L significantly reduced Major Adverse Cardiovascular Events (MACE) by 30% compared to controls across the population of 537 patients.
Mesoblast said it now intends to meet with the US Food and Drug Administration (FDA) to discuss a potential pathway to approval.