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Protalix Gains EU Approval for Extended Elfabrio Dosing

Story Highlights
  • On March 9, 2026, the European Commission approved a new every‑four‑weeks Elfabrio dosing regimen for stable adult Fabry patients in the EU.
  • The extended Elfabrio regimen should lower treatment burden, bolster Protalix’s Fabry market position, and unlock a $25 million milestone payment.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Protalix Gains EU Approval for Extended Elfabrio Dosing

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Protalix ( (PLX) ) just unveiled an update.

On March 9, 2026, Protalix BioTherapeutics and its partner Chiesi Global Rare Diseases announced that the European Commission approved a 2 mg/kg every‑four‑weeks dosing regimen for Elfabrio (pegunigalsidase alfa) in adults with Fabry disease who are stable on enzyme replacement therapy. The approval, based on data from the BRIGHT study and its extension, adds a new option in the EU alongside the existing schedule, while the U.S. regimen remains 1 mg/kg every two weeks.

The extended-interval regimen is expected to reduce treatment burden by cutting infusion frequency in half for eligible patients, potentially easing pressure on families and healthcare systems and enhancing long‑term disease management. For Protalix, the decision strengthens its position in the Fabry treatment market and triggers a $25 million regulatory milestone payment from Chiesi, underscoring the commercial significance of the new dosing schedule.

The most recent analyst rating on (PLX) stock is a Buy with a $12.00 price target. To see the full list of analyst forecasts on Protalix stock, see the PLX Stock Forecast page.

Spark’s Take on PLX Stock

According to Spark, TipRanks’ AI Analyst, PLX is a Neutral.

The score is driven primarily by improved profitability and a healthier balance sheet, offset by deteriorating TTM cash flow and shrinking recent revenue. Technicals are supportive but overbought, while valuation is a headwind given the high P/E and no dividend. Earnings-call updates and recent regulatory news are net positive but do not fully offset the cash-flow and growth concerns.

To see Spark’s full report on PLX stock, click here.

More about Protalix

Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs. The company, which partners with Chiesi Global Rare Diseases on Elfabrio, targets conditions such as Fabry disease with enzyme replacement therapies designed to improve long-term patient care.

Average Trading Volume: 1,183,895

Technical Sentiment Signal: Buy

Current Market Cap: $210.7M

Learn more about PLX stock on TipRanks’ Stock Analysis page.

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