Mesoblast shares are trading higher after the FDA informed the company that the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease.
Portfolio Pulse from Benzinga Newsdesk
Mesoblast shares surged following the FDA's indication that the clinical data from its Phase 3 study MSB-GVHD001 is sufficient to support the submission of a Biologics License Application for remestemcel-L, aimed at treating pediatric patients with steroid-refractory acute graft versus host disease.
March 26, 2024 | 12:14 pm
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POSITIVE IMPACT
Mesoblast's stock is likely to experience a positive short-term impact following the FDA's supportive stance on the clinical data for remestemcel-L, indicating a significant step forward in its regulatory approval process.
The FDA's indication of sufficient clinical data for Mesoblast's remestemcel-L represents a critical regulatory milestone, likely boosting investor confidence and driving short-term stock price appreciation.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100