Mesoblast Limited (MESO)
市前：
- Zacks
Mesoblast (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.
- Benzinga
After 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
- Insider Monkey
Mesoblast Limited (NASDAQ:MESO) Q2 2024 Earnings Call Transcript
Mesoblast Limited (NASDAQ:MESO) Q2 2024 Earnings Call Transcript February 29, 2024 Mesoblast Limited isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here). Silviu Itescu: Good morning, good afternoon to Mesoblast’s Financial Results and Operational Update for the Half Year ended December 31, […]
