MESO

RYONCIL™ (Remestemcel-L)

Acute graft-versus-host disease (aGVHD) – Pediatric

BLA Approval

Exp Date

December 2020 (Est)

Amp Volatility Score

N/A

Catalyst Info & Data Links

TITLE: RYONCIL™ (Remestemcel-L) in Acute graft-versus-host disease (aGVHD) – Pediatric BLA Approval

  • ClinicalTrial.gov (NCT02336230): A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD


WHAT IS THE CATALYST EVENT?

  • BLA approval

WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • December 2020


PRIOR DATA/EVENTS

PRESS RELEASE

MECHANISM OF ACTION / RATIONALE

  • Mesoblast’s lead allogeneic cell therapy product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the  production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

COMPETITORS


IMBRUVICA® (ibrutinib)

MARKET 

  • Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). 

  • Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.2 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.

Updated by MV

#MESO, #RYONCIL, #Remestemcel-L, #Acute graft-versus-host disease, #pediatric

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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Recent Posts

See What The Community Is Saying - Click To See Full Post

MESO - Novartis and Mesoblast ...

Summary: MESOBLAST ENTERS GLOBAL COLLABORATION FOR DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF REMESTEMCEL-L Initial Focus on Acute Respiratory Distress Syndrome, including COVID-19 #MESO "an...

MESO - 2nd Interim Analysis & ...

#MESO "today announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had receiv...

MESO - Randomized Controlled P...

#MESO "announced today that the randomized controlled Phase 3 trial of remestemcel-L on top of maximal care in ventilator-dependent patients with acute respiratory distress syndrome (ARDS) due to COVI...

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