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Stock Alert: Mesoblast Tanks 30%

Shares of Mesoblast Ltd. (MESO) are down over 30% on Tuesday morning after the U.S. FDA released two advisory reports related to Ryoncil, a stem cell treatment for children with a specific inflammatory condition. An FDA panel is slated to review Ryoncil on August 13, 2020.

Mesoblast is seeking Biologics License Application for approval of Ryoncil (remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease in children.

There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

The FDA's oncologic drugs advisory committee briefings conclude it is unclear whether clinical trial results submitted provide evidence of sufficient benefit in the treatment of SR-aGVHD.

FDA's ODAC will meet on Thursday to consider evidence of the effectiveness of Ryoncil.

"FDA's position is that the product attributes the Applicant has identified as related to potency and activity do not have a demonstrated relationship to the clinical performance of specific [drug protocol] lots, and that the product's proposed immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects receiving remestemcel-L," the briefing paper noted.

MESO is currently trading at $12.03, down $5.39 or 30.94%, on the Nasdaq.

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