Mesoblast Shares Tumble As FDA Strikes Out Cell Therapy Application For Children Again, Requires Additional Trial
Portfolio Pulse from Vandana Singh
Mesoblast Limited's (NASDAQ:MESO) shares fell after the FDA required an additional trial for its resubmission of remestemcel-L for pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA requires more data and Mesoblast will conduct a study in high-risk adults. The company has generated pilot data showing a survival benefit with remestemcel-L in this target population. However, analysts downgraded the stock due to a lack of clarity regarding the path forward for remestemcel-L.
August 04, 2023 | 3:29 pm
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NEGATIVE IMPACT
Mesoblast's stock price fell after the FDA required an additional trial for its resubmission of remestemcel-L. The company's future is uncertain due to a lack of clarity regarding the path forward for remestemcel-L.
The FDA's requirement for an additional trial for Mesoblast's remestemcel-L indicates that the agency is not yet satisfied with the data provided. This creates uncertainty about the future of the drug and the company, which is reflected in the stock price drop. The downgrade by analysts further exacerbates the negative sentiment.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100