Mesoblast LimitedNASDAQ: MESO

NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week.

NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference.

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.

Mesoblast's (MESO) Revascor (rexlemestrocel-L) gets FDA's Rare Pediatric Disease designation for treating children with congenital heart disease. Shares rise in after-hours trading.

Mesoblast Limited (MESO) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.

The FDA has rejected Mesoblast's cell therapy candidate for pediatric acute graft versus host disease, causing the stock to decline. Mesoblast is an old company located in Australia, which may impact its resonance with the FDA. The FDA has a bias against cell and other human biologic therapies, making approval for Mesoblast's therapy challenging.

Mesoblast Limited (NASDAQ:MESO ) Q4 2023 Results Conference Call August 30, 2023 6:30 PM ET Company Participants Dr. Silviu Itescu - Chief Executive Officer Dr. Eric Rose - Chief Medical Officer Andrew Chaponnel - Interim Chief Financial Officer Dr. Philip Krause - Board Member Conference Call Participants Louise Chen - Cantor Edward Tenthoff - Piper Sandler Sami Corwin - William Blair John Hester - Bell Potter Operator Hello and welcome to the Mesoblast Financial Results for the Period Ended June 30, 2023. An announcement and presentation have been lodged with the ASX and are also available on the home and investor [email protected].

Several analysts have recently downgraded their positions on the pharmaceutical stock. Mesoblast focuses on therapies derived from the cells of the bone marrow from healthy donors.

Mesoblast focuses on therapies to treat autoimmune disorders. The company's resubmission of Ryoncil was given a Complete Response Letter by the FDA.