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FDA Grants Orphan Drug Designation (ODD) to AlloVir’s Posoleucel, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy, for the Treatment of Virus-Associated Hemorrhagic Cysti...

AlloVir, Inc. (ALVR) 
Company Research Source: Business Wire
ODD for posoleucel adds to RMAT designation by FDA and OMP and PRIME designations by EMAPhase 3 registrational study of posoleucel in virus-associated hemorrhagic cystitis is ongoing CAMBRIDGE, Mass.--(BUSINESS WIRE)--AlloVir, Inc. (Nasdaq: ALVR), a late clinical-stage cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to posoleucel (Viralym-M, ALVR105) for the treatment of virus-associated hemorrhagic cystitis (HC). Posoleucel is an investigational, allogeneic, off-the-shelf, multi-virus specific T cell therapy under development for the treatment and prevention of serious diseases caused by six devastating viral pathogens: BK virus (BKV) and the related polyomavirus JC virus (JCV), cytomegalovirus (CMV), human herpes virus-6 (HHV-6), Epstein Barr virus (EBV) and adenovirus (AdV).An inflammatory disease of the bladder, virus-associated HC is a serious complication of hematopoietic stem cell transplantatio Show less Read more
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