Mesoblast Limited (NASDAQ: MESO) shares are trending upward in the US market today. At the latest observation during the pre-market session, Mesoblast’s stock demonstrated a notable ascent of 23.64% to $2.72. This surge follows a 1.85% increase in its stock price at the close of the previous session, reaching $2.20. The bullish movement of MESO stock correlates with advancements in a clinical development study.
Recently, Mesoblast (MESO) announced that the FDA in the United States has acknowledged that the clinical data from the Phase 3 trial MSB-GVHD001 that is currently available is considered sufficient to support the filing of a proposed Biologics License Application (BLA). For the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD), remestemcel-L is the subject of this application.
Mesoblast is substantially reassured by the FDA’s answers and instructions to move on with resubmitting their BLA for remestemcel-L in children suffering from SR-aGVHD. The company aims to initiate the resubmission process in the upcoming quarter, with a commitment to addressing any lingering product characterization concerns.
Mesoblast has recently secured firm commitments to fulfill its pro-rata accelerated non-renounceable entitlement offer, which was initiated on December 4, 2023. Dr. Eric Rose, Mesoblast’s Chief Medical Officer and a board member, has pledged to subscribe for additional shares worth A$1.5 million, contingent upon shareholder approval. Dr. Rose, a distinguished cardiac surgeon renowned for conducting the world’s inaugural successful heart transplant in children and formerly serving as Chairman of Columbia University’s Department of Surgery.
He played a pivotal role as Principal Investigator in the pivotal trial leading to FDA approval of the first implantable left ventricular assist device (LVAD) for long-term support of heart failure patients, thus catalyzing an entire industry. The entitlement offer, along with an institutional placement, collectively raised gross proceeds of A$97 million, which included A$36.7 million garnered this month from Mesoblast’s existing major shareholders, under similar terms as the Entitlement Offer.
