Why the Mesoblast (ASX:MSB) share price is rising 5% today

What did Mesoblast tell ASX investors today?

| More on:
A smiling woman looks at her computer laptop in her home with warm lights in the background feeling happy to see the EMvision share price rising

Image source: Getty Images

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

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.

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.

Motley Fool contributor Aaron Teboneras 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 Bruce Jackson.

More on Healthcare Shares

Cropped shot of an attractive young female scientist working on her computer in the laboratory.
Healthcare Shares

CSL share price leaping higher amid $1.9 billion funding news

ASX 200 investors are bidding up the CSL share price on Wednesday.

Read more »

Two happy scientists analysing test results.
Healthcare Shares

Mesoblast share price rockets 36% on breaking FDA news

ASX investors are sending the Mesoblast share price soaring following promising FDA news.

Read more »

a doctor in white coat and stethoscope stands in front of a building holding an electronic device in his hands.
Healthcare Shares

Guess which ASX 200 healthcare share is jumping 7% on a guidance update

This healthcare share is performing better than expected in FY 2024.

Read more »

a biomedical researcher sits at his desk with his hand on his chin, thinking and giving a small smile with a microscope next to him and an array of test tubes and beackers behind him on shelves in a well-lit bright office.
Earnings Results

Chemist Warehouse merger target Sigma reports 149% FY24 profit jump

This could be the last set of results from Sigma as we know it if its merger is approved.

Read more »

Cropped shot of an attractive young female scientist working on her computer in the laboratory.
Healthcare Shares

1 ASX healthcare stock that looks severely undervalued

I think this stock looks too cheap to miss.

Read more »

Stethoscope with a piggy bank and hundred dollar notes.
Healthcare Shares

Own Medibank shares? Here's why it's a rewarding day for you

Shareholders are getting a healthy boost today.

Read more »

Health professional looking at a laptop.
Healthcare Shares

Are CSL shares a must-buy in March?

Let's see what analysts are saying about this high-quality company.

Read more »

A woman jumps for joy with a rocket drawn on the wall behind her.
Healthcare Shares

This ASX healthcare stock is up 72% on FDA news and 'historic moment'

Huge gains are been recorded by this stock on Tuesday. But why?

Read more »