European Commission Approval of Elfabrio 4-Week Dosing
European Commission approved a 2 mg/kg every 4-week dosing regimen for Elfabrio for adults stable on enzyme replacement therapy, strengthening competitive positioning in the EU and differentiating Elfabrio versus competitors.
Regulatory Milestone and Near-Term Cash Inflow
The EU approval triggered a $25.0 million regulatory milestone payment from partner Chiesi, supporting a projected cash balance of approximately $50.0 million by early April 2026 (from $30.3 million at 12/31/2025).
2026 Revenue Guidance — Significant Growth Expected
Full-year 2026 total revenue guidance of $78.0 million to $83.0 million includes the $25.0 million milestone; expected Chiesi-related revenues of $33.0 million to $35.0 million (projected growth of more than 50% year-over-year) and Elelyso revenues of $20.0 million to $23.0 million.
Commercial Execution by Chiesi Driving Patient Growth
Chiesi reported consistent increases in patient numbers across the U.S. and key ex-U.S. markets, successfully growing both treatment-naive and switch patients and enhancing Elfabrio uptake and long-term market trajectory (Fabry market projected to reach ~$3.4 billion by 2030).
Advancing Clinical Pipeline — PRX-115 Enrollment
PRX-115 Phase II RELEASE study is actively enrolling with first patients randomized; topline results anticipated in the second half of 2027. Company positions PRX-115 as a potential best-in-class therapy for uncontrolled gout with differentiated dosing possibilities.
Pipeline Expansion and Partnerships
Protalix is expanding its rare renal pipeline (PRX-119, long-acting DNase) and collaborating on RNA-based programs with Secarna, indicating multiple development avenues beyond current commercial products.
Improved Cost Structure Signals
SG&A expenses declined slightly to $11.7 million in 2025 mainly due to lower share-based compensation; interest expense reduced following full repayment of secured convertible notes in 2024, partially offsetting FX-related financial expense.