Reported Sunday March 10, 2024, U.S. FDA Supports Accelerated Approval Pathway for Rexlemestrocel-L In End-Stage Heart Failure Patients With A Left Ventricular Assist Device
Portfolio Pulse from Benzinga Newsdesk
The U.S. FDA has indicated support for an accelerated approval pathway for Mesoblast Limited's rexlemestrocel-L, a treatment for end-stage ischemic heart failure patients with a left ventricular assist device (LVAD). This follows positive results from a pivotal study showing significant benefits, including reduced mortality and improved ability to wean off LVAD support. Mesoblast plans to request a pre-Biologics License Application meeting with the FDA to discuss further steps towards approval.
March 11, 2024 | 1:48 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Mesoblast's rexlemestrocel-L receives FDA support for accelerated approval in end-stage heart failure patients with LVAD, indicating a significant advancement in its regulatory journey and potential market impact.
The FDA's support for an accelerated approval pathway for rexlemestrocel-L significantly enhances Mesoblast's regulatory prospects and market potential. Given the positive study results and the unmet need in end-stage heart failure treatment, this development is likely to be viewed positively by investors, potentially leading to a short-term uptick in MESO's stock price.
CONFIDENCE 90
IMPORTANCE 95
RELEVANCE 100