STOCKS TELEGRAPH

Tag: MESO Stock Price

  • Mesoblast (MESO) Gains Pre-Hour Momentum With Key Regulatory Win

    Mesoblast (MESO) Gains Pre-Hour Momentum With Key Regulatory Win

    As of the latest check, Mesoblast Limited’s (NASDAQ: MESO) shares were up 38.86% to $17.01, a sharp increase during pre-market activity. This boost comes after one of the company’s main treatments received historic regulatory clearance.

    Mesoblast Receives An FDA Approval

    Mesoblast said that RYONCIL (remestemcel-L), which received regulatory clearance, is now the first mesenchymal stromal cell (MSC) therapy approved by the FDA in the US.

    RYONCIL is the first MSC medication licensed for any condition in the United States to treat steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children as young as two months, including adolescents and teens.

    A serious, sometimes fatal consequence, SR-aGvHD has a dismal prognosis. With this permission, doctors may now offer pediatric patients with few other options a potentially life-saving choice. Additionally, this milestone represents a significant development in MSC-based treatment strategies.

    Revolutionary Impacts

    In a pivotal Phase 3 clinical trial involving pediatric patients with severe SR-aGvHD, RYONCIL demonstrated a 70% overall response rate within 28 days, a strong predictor of survival. Its safety and tolerability profile were demonstrated by the fact that over 85% of patients got the medicine without any interruptions.

    The results of the whole experiment, which were released in the journal Biology of Blood and Marrow Transplantation, show how effective the medication is and how it may improve outcomes for young patients.

    Mesoblast’s Prospects for Upcoming Developments

    The FDA’s approval of RYONCIL solidifies Mesoblast’s position as a pioneer in MSC therapies. The company is committed to advancing its pipeline, including late-stage candidates like REVASCOR for cardiovascular conditions and rexlemestrocel-L for inflammatory pain.

    Additionally, Mesoblast plans to expand RYONCIL’s indications to address inflammatory conditions in both children and adults. RYONCIL will be made available at transplant centers and hospitals across the United States, providing hope and new possibilities for patients and families navigating SR-aGvHD.

    Addition In A Significant Index

    Mesoblast further said that it would shortly be included into the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the annual reconstruction of the 2024 Nasdaq index. Following the entrance of the U.S. market, Mesoblast will be added to the NBI on Monday, December 23, 2024.

  • Regulatory Approval Drives Sharp Increase In Mesoblast (MESO) Shares

    Regulatory Approval Drives Sharp Increase In Mesoblast (MESO) Shares

    Upon the announcement of the acceptance of Mesoblast Limited’s (NASDAQ: MESO) licensing application by regulatory authorities, the company’s shares have witnessed a significant rise on the US stock charts. The price of MESO shares increased by 9.27% to $8.25 as of the most recent check made during the current trading session.

    FDA Approves Mesoblast’s Application

    Mesoblast (MESO) said that their Biologics License Application (BLA) for resubmission has been accepted by the US Food and Drug Administration (FDA). Regarding Ryoncil, this BLA is intended for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

    The company’s top product candidate, Ryoncil, is an experimental treatment consisting of culture-expanded mesenchymal stromal cells taken from an unrelated donor’s bone marrow and given intravenously over many infusions.

    Immunomodulatory characteristics of ryoncil work against the inflammatory pathways linked to SR-aGVHD. This is accomplished by preventing effector T cell activation and proliferation, reducing pro-inflammatory cytokine production, and promoting the migration of anti-inflammatory cells to impacted tissues.

    Designations for Priority and Fast Track Reviews

    Remetemcel-L, the active component of Ryoncil, has been given Fast Track status by the FDA, which will speed up the research and evaluation of treatments for severe illnesses with unmet medical needs.

    It has also been granted the Priority Review classification, which is given to medications that treat critical illnesses and provide considerable increases in either safety or efficacy above currently available therapies.

    The FDA’s approval of the resubmission is regarded as a full response, and Mesoblast hopes to hear back from the agency by January 7, 2025, the Prescription Drug User Fee Act’s (PDUFA) deadline.

    In its resubmission on July 8, 2024, Mesoblast addressed the remaining Chemistry, Manufacturing, and Controls (CMC) issues in response to FDA input in March 2024 that said the clinical results from the Phase 3 trial MSB-GVHD001 looked good enough to warrant the BLA submission.

    Moreover, no Form 483 was issued as a consequence of the FDA’s Pre-License Inspection (PLI) of the remestemcel-L manufacturing process in May 2023.

    Implications for Ryoncil Approval

    The FDA’s acceptance of the BLA resubmission for review marks a critical step towards the potential approval of Ryoncil for treating children with SR-aGVHD, signifying a significant milestone for Mesoblast Limited.

  • Clinical Progress Spurs Mesoblast (MESO) Stock Rise In Pre-Market Trades

    Clinical Progress Spurs Mesoblast (MESO) Stock Rise In Pre-Market Trades

    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.