The Mesoblast Limited (ASX: MSB) share price is heading north today following a positive update regarding its remestemcel-L drug.
At the time of writing, the share price of the allogeneic cellular medicines company is up by 2.94% to $1.40.
However, in earlier trading, the Mesoblast share price reached $1.43, which is 5.1% above yesterday's close of $1.36.
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What did Mesoblast announce?
Investors are snapping up Mesoblast shares after the company provided a regulatory update on the appropriate potency assay on remestemcel-L.
According to the release, the company held discussions with US Food and Drug Administration's Office of Tissues and Advanced Therapies (OTAT) in response to the received complete response letter (CRL).
As such, Mesoblast requested to explore the potency assay and chemistry, manufacturing and controls (CMC) items for remestemcel-L.
The OTAT advised that the company's approach to addressing the outstanding CMC items is a reasonable critical quality attribute (CQA). OTAT also noted that the relevance of this activity to clinical outcomes should be established.
Mesoblast stated that it has generated substantial data that it believes meets the proposed in vitro immunomodulatory activity of remestemcel-L. This is demonstrated in its phase III trial in children with steroid-refractory acute graft versus host disease (SR-aGVHD).
The company will present its findings to the OTAT, and address other remaining CRL items as required, for the Biologics License Application resubmission.
What is remestemcel-L?
Mesoblast's lead drug candidate remestemcel-L is a cellular therapy product. It consists of cultured, cryopreserved mesenchymal stem cells derived from the bone marrow of healthy donors.
Remestemcel-L is being developed to treat steroid-refractory acute graft versus host disease (SR-aGVHD). However, Mesoblast has also been experimenting with remestemcel-L to treat patients infected with COVID-19.
About the Mesoblast share price
Over the past 12 months, Mesoblast shares have plummeted in value, sinking almost 40%.
The Mesoblast share price fell to a 52-week low of $1.31 earlier this month.
At today's price, Mesoblast has a market capitalisation of $908 million, with approximately 648 million shares on issue.
