Mesoblast (MESO) has released an update.
Mesoblast Limited has reported significant progress in its discussions with the FDA, receiving guidance on licensure paths for its innovative therapies, remestemcel-L for pediatric graft versus host disease, and rexlemestrocel-L for end-stage heart failure. The company is poised to resubmit its Biologics License Application for remestemcel-L and seeks an accelerated approval for rexlemestrocel-L following promising study results. With a strengthened balance sheet and cost containment strategies, Mesoblast continues to advance its late-stage product candidates, targeting severe inflammatory conditions.
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