Why is the Mesoblast share price surging 8% on Monday?

We take a look at the latest update from Mesoblast.

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Key points

  • Mesoblast shares are rising 8% today 
  • Mesoblast advised it has submitted new information to the FDA 
  • The company described this as a "major milestone"  

The Mesoblast Limited (ASX: MSB) share price is surging today on the back of a product update.

Mesoblast shares are lifting 7.69% today and are currently trading at 84 cents. For perspective, the S&P/ASX 200 Index (ASX: XJO) is down 0.33% today.

Let's take a look at what's impacting the Mesoblast share price today.

Mesoblast share price rises on "major milestone"

Mesoblast is working on allogeneic cellular medicines for inflammatory diseases.

Investors appear to be buying up Mesoblast shares after the company provided an update on a US Food and Drug Administration (FDA) application.

Mesoblast supplied the FDA with "substantial new information" on the use of remestemcel-L to treat children with steroid-refractory acute graft versus host disease (SR-aGVHD).

This new information is in response to a Complete Response Letter (CRL) from the FDA received in September 2020.

Mesoblast said this is a "major milestone" in the company's response to the FDA.

Commenting on the news, chief executive Dr Silviu Itescu said:

The submission summarizes controlled data providing further evidence of remestemcel-L's ability to save lives.

Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.

Mesoblast share price snapshot

The Mesoblast share price has fallen 49% in the past year, while it has lost 40% in the year to date. In the last month, Mesoblast shares have shed more than 1%.

In comparison, the ASX 200 has shed 10% in the past year.

Mesoblast has a market capitalisation of more than $619 based on the current share price.

Motley Fool contributor Monica O'Shea has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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