Stock Alert: FDA Clears Mesoblast's IND For Remestemcel-L; Stock Up 36%

(RTTNews) - Shares of Mesoblast Ltd. (MESO) are surging over 36% in pre-market today, after the company announced that the U.S. FDA has cleared its Investigational New Drug or IND application to use intravenous infusions of its allogeneic mesenchymal stem cell or MSC product candidate remestemcel-L to treat patients with acute respiratory distress syndrome or ARDS caused by coronavirus infection (COVID-19).

The company noted that Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.

Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS.

Mesoblast Chief Medical Officer Dr Fred Grossman said: "The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial."

The stock has been trading in the range of $3.12 - $10.88 for the past one year, and closed Friday's trade at $4.20, down 32 cents or 7.08%. MESO is currently trading at $5.75, up $1.55 or 36.90% in the pre-market trading session.