Mesoblast Limited (NASDAQ: MESO) is currently experiencing a surge in its stock value during the pre-market session, marking a notable increase of 24.15% to reach $6.22. This follows a substantial rise of 43.55% during the previous Friday session, concluding at $5.01. The continuation in upward trajectory of Mesoblast’s stock can be attributed to significant progress in regulatory approval processes.
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Mesoblast (MESO) has received confirmation from the U.S. Food and Drug Administration (FDA) that the clinical results from its Phase 3 trial MSB-GVHD001 seems sufficient to support the proposed Biologics License Application (BLA) for remestemcel-L. The treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD) is the goal of this application.
In response to the FDA’s comments, Mesoblast has confirmed its intention to refile the BLA for remestemcel-L in children suffering from SR-aGVHD and has gained a great deal of clarity and confidence in its regulatory approach. The company is poised to initiate the resubmission process in the upcoming quarter, with a strategic focus on resolving any remaining product characterization concerns.
Furthermore, Mesoblast has successfully secured firm commitments to finalize its pro-rata accelerated non-renounceable entitlement offer, which commenced on December 4, 2023. This initiative, coupled with an institutional placement, has generated gross proceeds totaling A$97 million. Notably, A$36.7 million was recently secured under the same terms as the Entitlement Offer, primarily from existing major shareholders of Mesoblast.
Among the notable participants in this initiative is Dr. Eric Rose, Mesoblast’s Chief Medical Officer and a distinguished member of its board. Dr. Rose’s subscription for additional shares amounting to A$1.5 million underscores his confidence in the company’s vision and potential. With a remarkable background as a pioneering heart surgeon and extensive contributions to medical innovation, Dr. Rose brings invaluable expertise to Mesoblast’s endeavors.
Mesoblast’s recent advancements underscore its commitment to advancing innovative therapies while fostering shareholder confidence through strategic initiatives and regulatory progress.
