Protalix BioTherapeutics advances Fabry disease and gout programs during 2025

Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) reported its 2025 fiscal results and outlined caller regulatory, objective and commercialized developments, including a caller European support for its Fabry illness therapy and updated guidance for 2026.

"2025 was a twelvemonth of meaningful advancement for Protalix, marked by beardown commercialized execution with our partners and important advances and strategical absorption crossed our objective and preclinical pipeline," the company’s CEO Dror Bashan said.

"The EC support of the E4W dosing regimen for Elfabrio successful the European Union represents an advancement for patients by reducing attraction load without compromising efficacy. This milestone strengthens the long–term worth of our Fabry franchise.”

The European Commission approved a 2 mg/kg every-four-weeks dosing regimen for Elfabrio successful adults with Fabry illness who are unchangeable connected enzyme replacement therapy.

The institution said the little predominant dosing docket reduces attraction load portion maintaining efficacy, supported by information from the BRIGHT survey and semipermanent hold results. Elfabrio is present the lone enzyme replacement therapy successful the European Union approved for monthly dosing, according to Protalix.

The support triggered a $25 cardinal milestone outgo from spouse Chiesi, which the institution said is expected to fortify its currency presumption to astir $50 cardinal by April 2026.

Protalix expects full gross successful 2026 to scope betwixt $78 cardinal and $83 million, including the milestone payment. Revenue from Elfabrio income is projected astatine $33 cardinal to $35 million, portion Elelyso income are expected to lend $20 cardinal to $23 million.

During 2025, gross from selling goods totaled $51.8 million, down 2% from $53 cardinal successful 2024. The diminution was chiefly owed to little income to Chiesi, partially offset by higher income to Pfizer and Brazil’s Fiocruz. Revenue from licence and probe and improvement services roseate to $0.9 million.

Cost of goods sold accrued 11% to $27 million, reflecting higher volumes supplied to Pfizer and Fiocruz.

Research and improvement expenses roseate 51% to $19.6 million, driven mostly by preparations for a Phase 2 survey of PRX-115.

The institution said its Phase 2 “RELEASE” proceedings of PRX-115, a recombinant PEGylated uricase for uncontrolled gout, is actively enrolling patients, with archetypal participants already randomized. Protalix believes the therapy could connection a long-acting attraction enactment with flexible dosing aimed astatine improving adherence and outcomes. Top-line results are expected successful the 2nd fractional of 2027.