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      Mesoblast Ltd. (MESO) Stock Dips Following Disclosure of Financial Reports for Q2 2021 - Stocks Telegraph

      By Shimrez Hyder

      Published on

      August 31, 2021

      4:06 PM UTC

      Mesoblast Ltd. (MESO) Stock Dips Following Disclosure of Financial Reports for Q2 2021 - Stocks Telegraph

      Mesoblast Ltd. (MESO) stock prices were down by 9.56% shortly after market trading commenced on August 31st 2021. This brought the price per share down to USD$6.62 early on in the trading day.

      MESO Stock Applies for EUA

      MESO stock reported a meeting with the United States Food and Drug Administration (FDA) in regard to the potential EUA for remestemcel-L. The emergency use authorization would be for the treatment of ventilator-dependent patients with moderate or severe acute respiratory distress syndrome ARDS, arising from Covid-19. The FDA concluded that an additional clinical study in Covid-19 ARDS would be required to approve the EUA. A statistically positive outcome could provide a dataset in conjunction with the recently completed 222 patient clinical study.

      Development of Remestemcel-L

      The U.S FDA provided MESO stock with guidance about the existing Covid-19 ARDS Investigational New Drug (IND) file and future submissions for remestemcel-L. The existing IND may continue to cross-reference manufacturing information in Biologics License Application (BLA) 125706 for pediatric steroid-refractory acute graft versus host disease. The FDA further indicated the requirement of potency assays needing to be established and agreed upon prior to the commencement of the proposed Phase 3 clinical trial.

      MESO Stock Working with FDA

      The company was also informed by the FDA that existing potency assays in development seemed to be reasonable, on the basis of in vitro results provided in relevant briefing documents. The in vitro activity of the product appears to be relatively well established, despite the relationship between in vitro activity and the product’s actual mechanism of action remains theoretical. MESO stock plans to meet with the FDA’s Office of Tissue and Advanced Therapies (OTAT) in the fourth quarter of 2021. Together, they will address potency assays for remestemcel-L in relation to SR-aGvHD, with the company posting that these attributes could also be relevant to Covid-19 ARDS.

      Partnership with Novartis

      MESO Stock has also entered into a license and collaboration agreement with Novartis. This partnership will facilitate the development, manufacture, and commercialization of remestemcel-L, with an initial focus on the treatment of ARDS. The agreement is contingent on certain closing conditions, as well as time to analyze the results from the Covid-19 ARDS trial.

      Future Outlook for MESO stock

      The company reported a promising quarter, as reflected by its promising financial and operational reports for Q2 2021. MESO stock is poised to capitalize on the opportunities afforded to it in the context of a pandemic that is once again gaining traction. Current and potential investors are hopeful that management will be able to usher in organic growth over the long term.

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