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.
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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.