Protalix Biotherapeutics, Inc. (PLX)

Protalix BioTherapeutics reported weaker-than-expected FY25 results but issued a strong FY26 revenue guidance. The European Commission approved an additional dosing regimen of every four weeks for Elfabrio. The CHMP issued a negative opinion on a request to approve a new dosing regimen for Elfabrio, causing PLX shares to drop. Protalix Biotherapeutics released its Third Quarter 2025 financial and business results, with EPS missing analyst expectations. The company reported its Second Quarter 2025 financial results, noting a 16% increase in revenues from selling goods compared to the same period in 2024, primarily driven by sales of Elfabrio to Chiesi. The stock price as of March 30, 2026, was $2.09 per share, representing an 18.36% decline from $2.56 per share on March 31, 2025.

Protalix expects global ordering patterns for Elfabrio to fluctuate quarterly during its early launch phase, stabilizing as the launch matures and market share expands. Chiesi tends to place orders towards the end of the year, potentially weighting revenue in the fourth quarter.

Protalix Biotherapeutics, Inc. is a biopharmaceutical company specializing in the development, production, and commercialization of recombinant therapeutic proteins for rare and specialty diseases, operating within the Healthcare sector and Biotechnology industry. Its major commercial products include Elelyso (taliglucerase alfa) for Gaucher disease, for which Protalix has licensed rights to Pfizer Inc. excluding Brazil, and Elfabrio (pegunigalsidase alfa) for Fabry disease, developed in partnership with Chiesi Farmaceutici S.p.A. Protalix also has product candidates in development, including PRX-115 for gout, PRX-119 for NETs diseases, and Alidornase alfa (PRX-110).

Protalix Biotherapeutics, Inc. is headquartered in Hackensack, New Jersey, United States, and maintains offices and a manufacturing facility in Carmiel, Israel. Its operations and partnerships extend across various countries and regions, including the United States, Brazil, and several European markets.

Protalix BioTherapeutics focuses on developing innovative medicines for patients with rare diseases. The European Commission approved an additional dosing regimen of every four weeks for Elfabrio, which could enhance its competitive advantage and patient adherence. The CHMP issued a negative opinion regarding a new, less frequent dosing regimen for Elfabrio, leading to a significant drop in the company's stock price and potentially impacting its reputation regarding the flexibility of its approved treatments.

Protalix Biotherapeutics, Inc. has a mixed ownership structure, including institutional, insider, and retail investors. Approximately 18.66% of the company's stock is held by institutional investors, 9.49% by company insiders, and 71.85% by other and public investors as of February 19, 2026. Major Institutional Owners include BlackRock, Inc., Opaleye Management Inc., and Renaissance Technologies Llc. Major Individual and Insider Owners include Biocell Ltd, Phillip Md Et Al Frost, and Zeev Bronfeld.