| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | December 27, 2024 9:00 A.M. |
| Form: | F-3 | ||||||
| |||||||
Save time and jump to the most important pieces.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 12/23/2024 | Buy → Hold | Jefferies | |
| 9/24/2024 | $12.00 | Hold → Buy | Maxim Group |
| 8/29/2024 | Hold → Buy | Jefferies | |
| 7/23/2024 | $4.00 → $11.00 | Neutral → Overweight | Piper Sandler |
| 8/31/2023 | Hold → Buy | Jefferies | |
| 8/7/2023 | Buy → Hold | Maxim Group | |
| 8/4/2023 | $7.00 → $2.00 | Overweight → Neutral | Piper Sandler |
| 8/4/2023 | Outperform → Mkt Perform | William Blair |
RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.In a single-arm, multi-center, Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or Grade D disease, 70% achieved an overall response by Day 28 of treatment with RYONCIL, a measure that predicts survival in aGVHD. RYONCIL'S immunomodulatory effects, including inhibition of T cell activation and secretion of pro-inflammatory cytokines, position t
NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (NASDAQ:NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast's inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024. The Nasdaq Biotechnology Index contains securities of Nasdaq-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals. The Nasdaq Biotechnology Index is calculated under a modified capitalization-weighted methodo
NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the United States Food and Drug Administration (FDA) has granted its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy Revascor® (rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. Mesoblast Chief Executive Silviu Itescu said: "We appreciate FDA's support i
NEW YORK, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: "During the past year we have built significant momentum in our interactions with the United States Food and Drug Administration (FDA) across each of our Phase 3 products. I am very pleased that our Biologics License Application (BLA) resubmission for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD)
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023. Mesoblast Chief Executive Silviu Itescu said: "We were very busy operationally during the last quarter and continued to have positive engagement with the United States Food and Drug Administration (FDA) across our lead programs. We have strengthened our balance sheet while maintaining overall spending constraint in line with our corporate objectives. For our product Ryoncil® (remestemcel-L) for life-threatening steroid-ref
NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and an operational update for the period ended June 30, 2023, and provided an overview of upcoming milestones. Mesoblast Chief Executive Silviu Itescu said: "We had anticipated that remestemcel-L would have been approved by the United States Food and Drug Administration (FDA) for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD), a condition with a high mortality where there are no approved therapies for children under 12 years old. During the six-month B
Jefferies downgraded Mesoblast from Buy to Hold
Maxim Group upgraded Mesoblast from Hold to Buy and set a new price target of $12.00
Jefferies upgraded Mesoblast from Hold to Buy
6-K - MESOBLAST LTD (0001345099) (Filer)
EFFECT - MESOBLAST LTD (0001345099) (Filer)
424B3 - MESOBLAST LTD (0001345099) (Filer)
SC 13G/A - MESOBLAST LTD (0001345099) (Subject)
SC 13G/A - MESOBLAST LTD (0001345099) (Subject)
SC 13G/A - MESOBLAST LTD (0001345099) (Subject)
KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announces the appointment of Schond Greenway as Chief Financial Officer (CFO). With more than 25 years of experience in corporate finance and investment analysis, Mr. Greenway has extensive biotechnology expertise, notably in navigating capital markets and spearheading successful fundraising initiatives. "We are thrilled to welcome Schond as our inaugural CFO. As we advance into clinical development with our lead program VET3-TGI, his proven track record in biotech finance and strategic leadership will be pivotal in steering KaliVir through our next
Dr. Grossman brings over 20 years of drug development expertise having held senior executive leadership positions in large and small pharmaceutical companies leading the development and FDA approval of numerous multi-billion dollar blockbuster drugs addressing significant unmet medical needs particularly across CNS disorders. Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. He served as President and Chief Medical Officer at Glenmark Pharmaceuticals (BSE: 532296) as well as Chief Medical Officer at Mesoblast, Inc. (NASDAQ:MESO). Dr. Grossman is Board-Certified in Psychiatry and a Fellow of the American Psychiatric Association
NEW YORK, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Jane Bell to its Board of Directors. Ms Bell is a banking and finance lawyer with 22 years of corporate finance expertise focussing on international investment transactions in the United States, Canada, Australia and the United Kingdom, including funds management, mergers, acquisitions, and divestments. She has served as a non-executive Director in a diverse range of highly regulated sectors including delivery of healthcare, life sciences, medical research, and funds management. Ms Bell curre