Delay hits Regenxbio BLA review
The US Food and Drug Administration (FDA) has extended Regenxbio’s (Nasdaq: RGNX) review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
With this delay, the Prescription Drug User Fee Act (PDUFA) goal date has been extended from November 9 this year to February 8, 2026.
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