Why Is Cell Therapy Focused-Mesoblast Stock Trading Higher On Monday?
Portfolio Pulse from Vandana Singh
Mesoblast Limited (NASDAQ:MESO) stock surged 17.2% in premarket trading after announcing FDA support for an accelerated approval pathway for rexlemestrocel-L for end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). The LVAD-MPC Study #2 showed significant benefits of rexlemestrocel-L over placebo in reducing mortality and improving weaning off LVAD support. Mesoblast plans to request a pre-BLA meeting with the FDA to discuss accelerated approval filing.
March 11, 2024 | 1:24 pm
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POSITIVE IMPACT
Mesoblast Limited's stock surged after FDA support for accelerated approval of rexlemestrocel-L for heart failure, showing significant study benefits.
The positive news about FDA support for an accelerated approval pathway for Mesoblast's rexlemestrocel-L directly impacts the company's potential market and revenue growth, especially given the significant study results showing reduced mortality and improved patient outcomes. This regulatory milestone is a strong positive signal to investors, likely leading to increased investor confidence and a short-term surge in stock price.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100