Protalix wins EU approval for monthly Elfabrio dosing, nets $25M
Protalix secured European Commission approval for a 2 mg/kg monthly Elfabrio dosing regimen, triggering a $25 million Chiesi milestone payment and boosting cash to about $50 million by April 2026. The company posted $51.8 million in 2025 revenue and expects $78–83 million in 2026 sales, including $33–35 million from Elfabrio.
1. European Approval and Milestone Payment
The European Commission approved a 2 mg/kg every-four-weeks dosing regimen for Elfabrio in adults with Fabry disease, making it the only monthly enzyme replacement therapy in the EU. This approval triggered a $25 million milestone payment from partner Chiesi, lifting Protalix’s projected cash balance to approximately $50 million by April 2026.
2. 2025 Financial Results
Protalix reported 2025 revenue of $51.8 million, a 2% decline from $53.0 million in 2024, primarily due to lower Chiesi orders offset by higher sales to Pfizer and Fiocruz. Cost of goods sold rose 11% to $27.0 million, while research and development expenses jumped 51% to $19.6 million as the company prepared for its Phase 2 PRX-115 gout trial.
3. 2026 Guidance and Pipeline Outlook
The company forecasted total 2026 revenue of $78–83 million, including $33–35 million from Elfabrio and $20–23 million from Elelyso sales. Enrollment is underway in the Phase 2 PRX-115 study for uncontrolled gout, with top-line data expected in the second half of 2027.