Mesoblast Limited (MESO)
After hours:
| Previous close | 5.11 |
| Open | 5.06 |
| Bid | 5.18 x 200 |
| Ask | 5.22 x 200 |
| Day's range | 5.06 - 5.34 |
| 52-week range | 1.61 - 10.24 |
| Volume | |
| Avg. volume | 2,246,672 |
| Market cap | 594.31M |
| Beta (5Y monthly) | 2.59 |
| PE ratio (TTM) | N/A |
| EPS (TTM) | -0.87 |
| Earnings date | N/A |
| Forward dividend & yield | N/A (N/A) |
| Ex-dividend date | N/A |
| 1y target est | 8.00 |
ZacksMesoblast (MESO) to File Pediatric GVHD Drug BLA, Stock Up
Mesoblast (MESO) gains as the FDA states that the available phase III data for lead candidate, remestemcel-L, is sufficient to support a regulatory filing for pediatric SR-aGVHD indication.
BenzingaAfter Almost 4 Years, FDA Says Mesoblast Phase 3 Therapy Data Can Support Resubmission For Serious Complications in Children Following Stem Cell Transplant
Monday, the FDA informed Mesoblast Limited (NASDAQ:MESO) that following additional consideration, the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). “We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of
GlobeNewswireUnited States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graf
