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Tag: Mesoblast Limited

  • 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.

  • 30 hot stocks trending in the pre-market session

    Naked Brand Group Limited (NAKD) stock plunged -4.92% to $0.1603 in the pre-market trading.

    Nano Dimension Ltd. (NASDAQ: NNDM)  shares are trading up 11.74% at $4.95 at the time of writing recently announced prices $100 million registered direct offering. Company’s 52-week ranged between $0.51 to $6.00. Analysts have a consensus price target of $8.

    BIO-key International Inc. (BKYI), a Security & Protection Services company, dropped about -6.14% at $2.75 in pre-market trading Monday after company recently announced that the Board of Directors has approved a 1-for-8 reverse stock split that is expected to become effective on November 20, 2020.

    Eiger BioPharmaceuticals Inc. (EIGR) stock moved up 9.67 percent to $11.0 in the pre-market trading following firm recently revealed that the U.S. Food and Drug Administration (FDA) has approved ZokinvyTM (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL).

    Lexicon Pharmaceuticals Inc. (LXRX) is down more than -5.33% at $1.42 in pre-market hours Monday November 23, 2020. The stock had dropped over -3.23% to $1.50 in the last trading session.

    Despegar.com Corp. (DESP), a Travel Services company, dropped about -6.54% at $10.01 in pre-market trading Monday.

    Bristol-Myers Squibb Company (BMY) stock moved up 1.41 percent to $62.48 in the pre-market trading today following announcement of  a discovery collaboration with Bristol Myers Squibb Company (NYSE: BMY) to discover, develop, and commercialize therapeutics in multiple disease areas.

    Niu Technologies (NIU) lost over -5.79% at $33.66 in pre-market trading Monday November 23, 2020 as the firm revealed changes to its board of directors and committees of the Board.

    Nxt-ID Inc. (NXTD) is up more than 8.36% at $0.389 in pre-market hours Monday November 23, 2020. The stock had dropped over -0.28% to $0.36 in the last trading session following the corporation said that it plans to adjourn the Annual Meeting of Stockholders, scheduled to be held on Monday, November 23, 2020 at 9:00 a.m. (Eastern Time), to Tuesday, November 24, 2020 at 9:00 a.m. (Eastern Time), to be held at the Company’s office at 288 Christian Street, Hangar C 2nd Floor, Oxford CT 06478.

    Before the trading started on November 23, 2020, Verb Technology Company Inc. (VERB) is up 9.26% to reach $1.18. It has been trading in a 52-week range of $0.78 to $2.64.

    CIIG Merger Corp. (CIIC) stock soared 13.29% to $19.26 in the pre-market trading.

    RedHill Biopharma Ltd. (NASDAQ: RDHL) shares are trading up 8.89% at $9.8 at the time of writing. Company’s 52-week ranged between $3.26 to $11.35 after announced that it has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.

    Xunlei Limited (XNET) gained over 12.0% at $3.08 in pre-market trading Monday November 23, 2020.

    Amarin Corporation plc (AMRN) is down more than -9.74% at $4.17 in pre-market hours Monday November 23, 2020 after shared positive, statistically significant top-line results from Protocol Number EDPC003R01, a Phase 3 clinical trial of VASCEPA® (icosapent ethyl) conducted in China by Amarin partner, Edding. The stock had jumped over 1.76% to $4.62 in the last trading session.

    United Microelectronics Corporation (UMC) grew over 8.65% at $6.28 in pre-market trading today.

    Baozun Inc. (BZUN), a Internet Retail company, dropped about -4.82% at $39.9 in pre-market trading Monday. The firm today announced that its Board of Directors has appointed Mr. Arthur Yu, the Company’s current Vice President of Finance, as Chief Financial Officer (“CFO”), effective December 1, 2020.

    Pioneer Power Solutions Inc. (PPSI) stock moved up 10.49 percent to $4.32 in the pre-market trading.

    SPI Energy Co. Ltd. (SPI) gained over 8.79% at $10.4 in pre-market trading Monday November 23, 2020.

    Bio-Path Holdings Inc. (BPTH) is down more than -0.54% at $3.65 in pre-market hours Monday November 23, 2020 as a result of announcement that the enrollment and dosing of the first patient in a Phase 1 clinical trial evaluating the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients. The stock had jumped over 9.88% to $3.67 in the last trading session.

    Before the trading started on November 23, 2020, Fuel Tech Inc. (FTEK) is up 19.69% to reach $1.52. It has been trading in a 52-week range of $0.30 to $2.05.

    Medigus Ltd. (MDGS) stock soared 8.48% to $3.07 in the pre-market trading after the firm announced its intention to enter into the electric vehicle and electric charging markets. Medigus signed a non-binding memorandum of understanding with the founders of EMuze to invest in a joint venture, NewCo, for the commercialization of EV micro-mobility vehicles for individual urban use, “last mile” and cargo delivery.

    GreenPower Motor Company Inc. (NASDAQ: GP) shares are trading up 11.34% at $24.54 at the time of writing as the news appeared that the Company has granted an aggregate of 300,000 incentive stock options with 100,000 stock options to each of Brendan Riley, Michael Sieffert and Fraser Atkinson. The stock options are subject to the approval of the TSX Venture Exchange and are exercisable for a period of five years at a price of US $20 per share. Company’s 52-week ranged between $0.82 to $23.45. Analysts have a consensus price target of $22.

    Check-Cap Ltd. (CHEK) grew over 7.1% at $0.38 in pre-market trading today.

    Mesoblast Limited (MESO), a Biotechnology company, rose about 9.8% at $15.13 in pre-market trading Monday after announcement of financial results for the third quarter and nine months ended September 30, 2020

    Titan Pharmaceuticals Inc. (TTNP) stock moved down -5.62 percent to $0.193 in the pre-market trading.

    The9 Limited (NCTY) gained over 21.45% at $3.68 in pre-market trading Monday November 23, 2020 as the company revealed that it will hold its annual general meeting of shareholders at the 17 Floor, No. 130 Wu Song Road, Hong Kou District, Shanghai 200080, People’s Republic of China on December 22, 2020 at 2:00 p.m., Shanghai time.

    Before the trading started on November 23, 2020, CPS Technologies Corporation (CPSH) is up 30.0% to reach $3.12. It has been trading in a 52-week range of $0.88 to $3.35.

    Canaan Inc. (CAN) stock soared 17.52% to $5.03 in the pre-market trading following the company plans to release its third quarter 2020 financial results before the market opens on Monday, November 30, 2020.

    Ferroglobe PLC (GSM), a Other Industrial Metals & Mining company, rose about 24.46% at $1.16 in pre-market trading Monday.

    Ideanomics Inc. (IDEX) stock moved up 37.01 percent to $2.11 in the pre-market trading after the company announced that it has increased its stake in California-based Solectrac, Inc. through a follow-on investment of an additional $1.3 million.