Mesoblast share price frozen ahead of FDA news

The Mesoblast Ltd (ASX: MSB) share price won’t be going anywhere on Wednesday.

That’s because the biotechnology company has just requested a trading halt.

Why is the Mesoblast share price halted?

According to the request, the company has asked for its shares to be out of action until Friday at the latest.

This is so that it can prepare an announcement in relation to the U.S. Food and Drug Administration’s (FDA) review of its Biologics License Application (BLA) resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (aGVHD).

This review is arguably the pivotal moment in the company’s history, so there certainly is a lot riding on this.

What do you need to know?

As covered here recently, the US FDA promised to give Mesoblast a decision on its remestemcel-L therapy by 2 August.

Bell Potter described this review as “make or break” for the company, so expect huge movement from the Mesoblast share price when it returns to trade.

The good news is that its analysts believe that this movement could be to the upside. That’s because they feel that there’s a good chance that the US FDA will finally give its thumbs up to the stem cell therapy. It said:

The company resubmitted the Biological License Application (BLA) in January 2023 which was formally accepted for review in March. This was followed by a pre license inspection (by 4 FDA inspectors) of the manufacturing process for remestemcel-L at the Lonza manufacturing facility in Singapore in May. The inspection is considered to have gone well and did not result in the issuance of any form 483 (being potential violations of laws regulating drug manufacturing for use in the USA).

The four year survival data for Remestemcel – L indicates a clean safety profile and a survival rate of 49% and we believe this long term survival data along with overwhelming support of physicians should be sufficient to obtain an approval. The approval of any new class of therapy can never be taken for granted, nevertheless the data package supporting approval on this occasion is substantially stronger than in 2020.

Stay tuned for its update tomorrow or Friday.