Protalix BioTherapeutics secures €25M after EU dosing approval, forecasts 50% growth
Protalix BioTherapeutics received a €25 million milestone payment after EU approval of its less frequent EFrio dosing regimen, boosting projected cash to $50 million by April 2026. The company posted a $6.6 million net loss in 2025 as R&D expenses climbed 51%, with U.S. approval timing unclear.
1. EU Dosing Approval and Milestone Payment
Protalix obtained European Commission approval for a 1-to-4-week EFrio dosing regimen for Fabry disease, triggering a €25 million milestone payment and enhancing its competitive position in the EU market.
2. Cash Position and 2026 Revenue Outlook
The company projects holding approximately $50 million in cash by early April 2026 and anticipates over 50% revenue growth next year, driven by expanded patient uptake and additional regulatory milestones.
3. 2025 Financial Performance
Protalix recorded a $6.6 million net loss in 2025 as R&D expenses rose 51% and cost of goods sold reached $27 million, while revenue from licensing and R&D services remained minimal.
4. Pipeline Progress and U.S. Approval Timing
The PRX 115 gout candidate has entered phase II trials with flexible dosing options, but the company has not yet set a timeline for U.S. approval of the new EFrio regimen.