Mesoblast Advances Toward Remestemcel-L Approval for Pediatric SR-aGVHD: FDA Meeting Update
Portfolio Pulse from Benzinga Newsdesk
Mesoblast Limited (NASDAQ:MESO) has provided an update on the path to approval for its lead-product candidate remestemcel-L in the treatment of pediatric and adult steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA clarified that the key remaining issue for pediatric approval is providing further evidence that the potency assay will assure the consistent efficacy of the commercial product. Mesoblast intends to generate new potency assay data for RYONCIL in the coming months and believes these additional data will provide a link between the RYONCIL product used in the Phase 3 trial and the RYONCIL product which will be used in a future trial for the adult indication.
September 21, 2023 | 7:33 am
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Mesoblast is advancing towards FDA approval for its lead-product candidate remestemcel-L. The company intends to generate new potency assay data for RYONCIL in the coming months, which could potentially impact the stock positively if successful.
The news about Mesoblast's progress towards FDA approval for its lead-product candidate remestemcel-L is directly related to the company and its stock. If the company is successful in generating the required potency assay data for RYONCIL, it could potentially lead to FDA approval, which would likely have a positive impact on the stock.
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