FDA Accepts Mesoblast's Biologics License Application (BLA) For Ryoncil In Children With Steroid-Refractory Acute Graft-Versus-Host Disease
Portfolio Pulse from Benzinga Newsdesk
The FDA has accepted Mesoblast's Biologics License Application (BLA) for Ryoncil, a treatment for children with steroid-refractory acute graft-versus-host disease. This is a significant milestone for Mesoblast as it moves closer to potentially bringing Ryoncil to market.
July 23, 2024 | 11:56 am
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POSITIVE IMPACT
The FDA's acceptance of Mesoblast's BLA for Ryoncil is a significant regulatory milestone, potentially paving the way for market approval and commercialization. This could positively impact Mesoblast's stock price in the short term.
The acceptance of the BLA by the FDA is a critical step in the regulatory process, indicating that the application is sufficiently complete to warrant a full review. This increases the likelihood of eventual approval and commercialization, which is likely to boost investor confidence and positively impact the stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100