Protalix and Chiesi agree plan with FDA to progress Fabry candidate PRX-102

7 February 2020

Israeli biotech Protalix BioTherapeutics (TASE: PLX) and commercialization partner, Italy’s family-owned Chiesi Farmaceutici, have entered into an agreement with the US Food and Drug Administration for the Initial Pediatric Study Plan (iPSP) for pegunigalsidase alpha, or PRX-102.

The companies reported the news after completing discussions with the FDA and receiving confirmation in an official "Agreement Letter" which outlines an agreed approach to address the needs of pediatric patients with Fabry disease. The development saw the Israeli firm’s share rise 2.67% to 1,268 shekels.

PRX-102 is Protalix' plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A candidate for the treatment of Fabry disease. PRX-102 has the potential to be approved for adult patients with Fabry disease under the FDA's Accelerated Approval pathway.

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