Mesoblast tanks as FDA issues CRL

4 August 2023

Australian regenerative medicine company Mesoblast (ASX: MSB) saw its shares plunge almost 57% to A$0.47 after it revealed a second setback in the development of it remestemcel-L.

Mesoblast said that the US Food and Drug Administration (FDA) has provided a complete response letter (CRL) to its Biologics License Application (BLA) resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) and requires more data to support marketing approval. In 2020, the FDA slapped the first CRL on the BLA.

To obtain the data required, Mesoblast will conduct a targeted, controlled study in the highest-risk adults with the greatest mortality. This adult study is in line with our overall commercial strategy, which envisioned a sequenced progression from pediatric to adult SR-aGVHD indications. Adults comprise 80% of the SR-aGVHD market.

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