GlobeNewsWire
01 Jul 2026, 00:38 UTC · 2h ago
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Mesoblast has received a BLA filing number from the FDA and requested a modular review for rexlemestrocel-L for end-stage heart failure patients with LVADs. — Receiving a filing number indicates the FDA has accepted the application for review, a critical step toward commercialization for a biotech company.
+0.60Rexlemestrocel-L has received Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations for this specific patient population. — These designations provide regulatory advantages, including eligibility for priority and rolling reviews, which can accelerate the time to market.
+0.40The FDA has released new draft guidance signaling increased regulatory flexibility for products treating rare diseases with high mortality and morbidity. — A more flexible regulatory environment reduces the risk of rejection or requests for additional costly trials for orphan drugs.
+0.30Which stocks this story touches
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The company received a BLA filing number from the FDA and requested a modular review for its rexlemestrocel-L therapy.
The company received a BLA filing number from the FDA and requested a modular review for its rexlemestrocel-L therapy.
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