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Protalix Faces EMA Setback on Elfabrio® Dosing

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Protalix Faces EMA Setback on Elfabrio® Dosing

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Protalix ( (PLX) ) has issued an announcement.

On October 17, 2025, Protalix BioTherapeutics and its partner Chiesi Global Rare Diseases announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the proposed dosing regimen for Elfabrio®. This decision may impact the company’s market strategy and regulatory approach for Elfabrio® in Europe, potentially affecting stakeholders and future commercial plans.

The most recent analyst rating on (PLX) stock is a Hold with a $2.00 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.

Protalix’s overall stock score reflects strong earnings growth and promising product developments, offset by high leverage and inconsistent revenue growth. The recent CFO appointment and technical indicators suggest potential for future improvement.

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

More about Protalix

Protalix BioTherapeutics, Inc. is a pharmaceutical company specializing in the development of recombinant proteins for the treatment of rare diseases. The company is known for its proprietary ProCellEx® platform, which focuses on plant cell protein expression and enzyme replacement therapies. Protalix has commercialized products such as Elfabrio® and Elelyso, with global partnerships including Chiesi Global Rare Diseases and Pfizer Inc.

Average Trading Volume: 702,725

Technical Sentiment Signal: Buy

Current Market Cap: $191.4M

See more insights into PLX stock on TipRanks’ Stock Analysis page.

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