Mesoblast Limited (NASDAQ: MESO) stock surged almost 80% on Tuesday following a pivotal announcement from the Food and Drug Administration (FDA).
Mesoblast (MESO) has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Phase 3 study MSB-GVHD001, signaling a significant step forward in the development of remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Mesoblast (MESO) received notification from the U.S. FDA stating that the available clinical data from its Phase 3 study MSB-GVHD001 is adequate to support the submission of the proposed Biologics License Application (BLA) for remestemcel-L.
Dr. Silviu Itescu, CEO of Mesoblast, expressed gratitude for the FDA’s collaborative approach, stating,
“We thank the agency for their collaborative approach. The responses and guidance from the FDA are clear and give us a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD.”
Mesoblast aims to initiate the resubmission process next quarter, focusing on addressing all remaining product characterization issues.
This positive development follows Mesoblast’s recent earnings report for the half-year ended December 31, 2023. The company reported sales of $3.39 million, slightly down from $3.42 million in the same period a year ago. The net loss for the period was $32.54 million, compared to $41.37 million a year ago.
The company reported a basic loss per share from continuing operations of $0.0382, improving from $0.0564 a year ago. In addition, diluted loss per share from continuing operations came in at $0.0382, compared to $0.0564 in the previous year.
Mesoblast (NASDAQ: MESO) Stock Price Action
MESO stock soared 78.64% to close at $3.93 on Tuesday. The traders had exchanged hands with 68,338,200 (68.33 million) shares compared to the average daily trading volume of 404.44K.
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