Mesoblast Limited
PDUFA AI-extracted
rexlemestrocel-L
chronic heart failure with low ejection fraction (HFrEF)
Date
TBD
FDA decision · Date TBD estimated
What's at stake The FDA's approval decision on rexlemestrocel-L for chronic heart failure with low ejection fraction (HFrEF) is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“Mesoblast is moving from filing for accelerated approval to filing for full FDA approval next quarter.”

Provenance

1 source on file.

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