The Mesoblast Ltd (ASX: MSB) share price is having a very strong start to the month.
At the time of writing, the biotechnology company's shares are up almost 13% to $1.07.
Whys is this ASX All Ords biotech share rocketing higher?
Investors have been scrambling to buy the ASX biotech's shares following the release of a positive regulatory update.
According to the release, the allogeneic cellular medicines developer has resubmitted to the U.S. Food and Drug Administration (FDA) its Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
The company notes that the resubmission contains substantial new information as required by the FDA.
This includes new long-term survival data of children enrolled in the Phase 3 trial showing durability of treatment effect through at least four years and new data showing remestemcel-L's treatment benefit in high-risk disease activity and on survival in propensity-matched studies of children in the Phase 3 trial.
It also highlights that new data shows that the validated potency assay has low variability and can adequately demonstrate manufacturing consistency and reproducibility. The lack of consistency was a key issue that the FDA had previously brought up.
All in all, management appears hopeful that this will be enough to get remestemcel-L approved by the FDA this time around.
Mesoblast's chief executive, Dr. Silviu Itescu, commented:
There is an urgent need for a therapy that improves the dismal survival outcome in children with SRaGVHD. Our team has worked tirelessly over the past two years to provide a comprehensive response to the FDA. We are grateful for the agency's active dialogue and constructive feedback that will ensure a high bar is met in terms of product consistency and predictability of clinical outcomes.
Pleasingly, shareholders won't have too long to wait for a result. The resubmission will have a review period up to six months from filing upon acceptance by FDA.
