Stock Track | Mesoblast Soars 5.12% Intraday on FDA BLA Filing Number for Rexlemestrocel-L Heart Failure Therapy

Stock Track

07/01

MESOBLAST LTD (MSB.AU) shares soared 5.12% during intraday trading on Wednesday, driven by a significant regulatory milestone for its lead therapy candidate.

The biotech company announced it received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration for rexlemestrocel-L. The therapy is intended to prevent gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD).

Mesoblast also requested a modular review of the BLA, a process that can potentially expedite the regulatory pathway. The therapy holds both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation, which support eligibility for rolling or priority review by the FDA, highlighting the treatment's potential to address an unmet medical need.

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