Stock of the Day

January 9, 2020

Mesoblast (MESO)

$13.38
-$0.57 (-4.1%)
Market Cap: $1.74B

About Mesoblast

Mesoblast Limited engages in the development of regenerative medicine products in Australia, the United States, Singapore, and Switzerland. The company offers products in the areas of cardiovascular, spine orthopedic disorder, oncology, hematology, and immune-mediated and inflammatory diseases. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage cells. The company offers Remestemcel-L that is in Phase III clinical trials for the treatment of systemic inflammatory diseases, including steroid refractory acute graft versus host disease, acute respiratory distress syndrome, and biologic refractory inflammatory bowel disease; and Remestemcel-L, which is in Phase III clinical trials to treat chronic heart failure and chronic low back pain due to degenerative disc disease. It is also developing MPC-300-IV to treat biologic refractory rheumatoid arthritis diabetic nephropathy; and MPC-25-IC for the treatment or prevention of acute myocardial infarction. It has strategic partnerships with Tasly Pharmaceutical Group to offer MPC-150-IM for heart failure and MPC-25-IC for heart attacks in China; JCR Pharmaceuticals Co. Ltd. to treat wound healing in patients with epidermolysis bullosa; and Grünenthal to develops and commercializes cell therapy for the treatment of chronic low back pain. The company was incorporated in 2004 and is headquartered in Melbourne, Australia.

Today's Trend

Mesoblast Limited (NASDAQ: MESO; ASX: MSB) received U.S. Food and Drug Administration (FDA) approval for a new potency assay, the T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of all new commercial lots of Ryoncil (remestemcel-L-rknd).

  • The FDA clearance should support Mesoblast’s ability to release and monitor commercial Ryoncil batches, reducing a potential manufacturing and regulatory hurdle. The announcement initially helped MESO trade higher in premarket activity. Mesoblast Receives FDA Approval for New Potency Assay
  • The regulatory decision concerns the testing method used to release and monitor Ryoncil, rather than a new indication or expansion of the product’s approved use. Investors may therefore view it as an operational milestone with limited immediate revenue impact. Mesoblast Gets FDA Approval for New Ryoncil Potency Assay
  • A report stating that short interest totaled zero shares implies no measurable short-selling pressure, but the figure conflicts with the description of a “large increase” and may reflect incomplete or unreliable data. Mesoblast Secures US FDA Approval for New Potency Assay
  • Despite the FDA announcement, MESO came under pressure and was reported below its 50-day moving average. This suggests some investors may have taken profits or considered the approval already priced in, creating a negative technical signal in the near term. Mesoblast Shares Cross Below 50 Day Moving Average
← Previous Stock of the DayNext Stock of the Day →

Recent News