In morning trade the Mesoblast limited (ASX: MSB) share price has charged higher.
At the time of writing the allogeneic cellular medicines developer’s shares are up over 8% to $1.94.
Why is the Mesoblast share price charging higher?
Investors have been buying the company’s shares this morning after it announced a new agreement with integrated solutions provider Lonza.
According to the release, the two parties have entered into an agreement for the commercial manufacture of Mesoblast’s lead cell therapy product candidate, remestemcel-L for pediatric steroid-refractory acute graft versus host disease (aGVHD).
The release explains that this agreement will facilitate inventory build ahead of the planned United States market launch of remestemcel-L and commercial supply to meet its long-term market projections.
Mesoblast expects to complete the filing of the rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) by the end of this year.
Once accepted, the product is eligible for FDA priority review under its existing Fast Track designation. After which, if it is approved, the US launch of remestemcel-L is expected to occur next year.
Mesoblast’s chief executive, Dr Silviu Itescu, explained: “This commercial manufacturing agreement with Lonza for our lead product candidate is designed to ensure that we are in a position to meet projected commercial demand as we plan to roll out the first of our allogeneic cell therapies to people around the world in need of life-saving and disease-modifying products.”
Lonza’s Alberto Santagostino, spoke very highly of Mesoblast and appears to see a lot of potential in remestemcel-L and other products.
He said: “Mesoblast is a true trailblazer, leading the way in developing life-changing cell therapies and working hard to soon make them available to large numbers of patients. This agreement builds on the successful partnership and alliance between our two companies over the years.
“As we also enter new partnerships with early-stage companies on one side, Mesoblast shows the path of success in reaching commercialization on the other. We are committed for the long run with Mesoblast, to continue to grow and deliver cell therapies to all patients in need, together,” Santagostino concluded.
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James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of CSL Ltd. and Nanosonics Limited. The Motley Fool Australia has recommended Nanosonics Limited. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.