Important announcement

@EMA_News has granted orphan drug designation to RLS-0071 (pegtarazimod) for the treatment of #GvHD, based on preliminary data from an ongoing phase II study including patients with SR-aGvHD. Read more: https://loom.ly/Ozl53ck

On June 2, 2025, a marketing authorization application was submitted to the @EMA_News for MaaT013, a pooled fecal microbiota product, for the treatment of gastrointestinal acute #GvHD. This follows positive data from the Pivotal ARES study. Read more: https://businesswire.com/news/home/20250602568637/en/MaaT-Pharma-Advances-Toward-Commercialization-And-Submits-Marketing-Authorization-Application-to-the-European-Medicines-Agency-EMA-for-Xervyteg-MaaT013-in-Acute-Graft-versus-Host-Disease

On March 11, 2025, the EMA Pediatric Committee provided a positive opinion and cleared the pediatric investigation plan to assess MaaT013 in patients from 6 years old to <18 years old with aGvHD. The study is planned to start in 2026. Read more: https://businesswire.com/news/home/20250311353696/en/MaaT-Pharma-Receives-Positive-Opinion-from-EMA-Pediatric-Committee-on-the-Pediatric-Investigation-Plan-for-MaaT013

@US_FDA approves remestemcel-L, an allogeneic bone marrow-derived MSC therapy, for the treatment of pediatric patients (aged ≥2 months) with SR-aGvHD, based on data from the MSB-GVHD001 study. Read more: https://loom.ly/0g3c-cc