FDA grants RMAT designation to AlloVir's posoleucel

Shares of USA-based AlloVir (Nasdaq: ALVR) shot up more than 46% to $7.90 in mid-morning trading, after it announced that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational multi-virus-specific T cell therapy, posoleucel.

The drug candidate is intended for the prevention of clinically significant infections and disease from six devastating viruses that commonly impact high-risk adult and pediatric patients following allogeneic hematopoietic cell transplant (allo-HCT) – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV).

This is the third RMAT designation that the FDA has granted to posoleucel, in recognition of the therapy’s transformative potential to address significant unmet medical needs facing immunocompromised allo-HCT patients.