The Mesoblast Ltd (ASX: MSB) share price is having a disappointing session on Tuesday.
In morning trade, the biotechnology company's shares are down 4.5% to $1.07.
As a comparison, the ASX 200 index is up 0.65% at the time of writing.
Image source: Getty Images
What's going on with the Mesoblast share price?
Investors have been selling the allogeneic cellular medicines developer's shares this morning despite the release of an announcement relating to its Ryoncil (remestemcel-L) product.
According to the release, the company has resubmitted its biologic license application (BLA) for the approval of Ryoncil in the treatment of children with steroid-refractory acute graft-versus-host disease (SR-aGVHD).
Management notes that the filing of this resubmission comes after Mesoblast was informed by the United States Food & Drug Administration (FDA) at the end of March that, following additional consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of paediatric patients with SRaGVHD.
It also highlights that the new filing addresses remaining CMC (Chemistry, Manufacturing, and Control) items.
Commenting on the resubmission, Mesoblast's CEO, Dr. Silviu Itescu, said:
We have worked closely with the agency and thank them for their ongoing guidance, facilitating the potential approval of RYONCIL and addressing the urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD.
What now?
The US FDA previously granted remestemcel-L Fast Track designation. This is a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs.
In addition, it has been granted Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments.
As a result, the BLA resubmission is expected to have a review period of between two and six months from receipt once accepted.
Why are its shares falling?
Today's weakness in the Mesoblast share price could be a case of buy the rumour and sell the news.
In addition, there could be some profit taking going on from some investors that aren't keen to stick around for up to six months to get a response from the US FDA.
After all, over the past six months the Mesoblast share price has risen an enormous 285%. This means that investors buying in January would have almost quadrupled their money.
Here's hoping for good news in the coming months for its remaining shareholders.
