CHIESI FARMACEUTICI S.P.A.

Protalix BioTherapeutics, Inc. shares accomplishments in 2024, including EMA validation for pegunigalsidase alfa dosing, phase I trial results for PRX-115, and repayment of convertible notes. The company looks forward to advancing PRX-115 and pipeline developments in 2025.

EMA validates variation submission for pegunigalsidase alfa to label a 2 mg/kg dose every four weeks in adult Fabry disease patients, supported by clinical data from Phase 3 studies.

EMA validates Chiesi and Protalix's submission for pegunigalsidase alfa, proposing a 2 mg/kg dose every four weeks for Fabry disease treatment, compared to the current 1 mg/kg every two weeks regimen.

Protalix BioTherapeutics reports financial results for Q3 2024, highlighting completion of phase I PRX-115 study for gout treatment. Preliminary results show PRX-115's potential as an effective uric acid-lowering treatment. The company plans to initiate a phase II clinical trial in H2 2025. Financial highlights include $17.8M in revenue, a $3.2M net income, and $27.4M in cash and cash equivalents.

The global oral proteins and peptides market is projected to reach USD 20.36 billion by 2029, driven by increasing demand for oral peptides in treating chronic diseases, R&D investments, and advancements in drug delivery technologies. The US dominates the market, supported by a strong biopharmaceutical sector and presence of key players like Novo Nordisk and Pfizer. Semaglutide leads in molecule segments, used for managing type-2 diabetes and obesity.

Chapters cover methodology, executive summary, market variables, segmentation by disease, molecule, biological target, mechanism, and region, and competitive landscape.