Protalix updates on PRX-102 FDA PDUFA date May 9, 2023; PRX-115 Phase I in Q1 2023

Protalix BioTherapeutics, Inc.

MAA submitted to EMA Feb 2022; BLA resubmitted to FDA Nov 2022 with PDUFA goal date May 9, 2023.
BALANCE study: PRX-102 statistically non-inferior to agalsidase beta on eGFR slope; BRIGHT: stable disease.
PRX-115 (PEGylated uricase) for severe gout: Phase I trial planned for Q1 2023; preclinical data show stable PK and low immunogenicity.
If PRX-102 approved by FDA, Protalix eligible for milestone payment from partner Chiesi.

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