Protalix BioTherapeutics

PLX

Market cap $187M

Protalix BioTherapeutics reported weaker FY25 results but issued robust FY26 revenue guidance of $78–83 million, well above consensus. PLX's growth thesis centers on Elfabrio's EU approval and once-every-4-weeks dosing, offering a clear competitive and patient adherence advantage. Chiesi's contribution is expected to exceed 50% revenue growth in 2026, improving margin mix and earnings predictability despite near-term volatility.

Protalix BioTherapeutics, Inc. (PLX) Q4 2025 Earnings Call Transcript

Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) reported its 2025 financial results and outlined recent regulatory, clinical and commercial developments, including a new European approval for its Fabry disease therapy and updated guidance for 2026. "2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline," the company's CEO Dror Bashan said.

Company to host conference call and webcast today at 8:00 a.m. EDT The European Commission (EC) approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® in adults living with Fabry disease providing a meaningful reduction in treatment burden without compromising efficacy The EC approval triggered the Company's entitlement to a $25.0 million milestone payment from Chiesi, strengthening the Company's cash position and supporting an expected cash balance of approximately $50.0 million by April 2026 Based on current estimates, management expects total revenues in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million payment referenced above The Phase 2 clinical trial of PRX–115 is actively enrolling; the Company believes PRX-115 has the potential to be a best-in-class therapy, improving uncontrolled gout patients' compliance and outcomes Continued strategic focus on rare renal diseases to build a pipeline through innovation and partnerships CARMIEL, Israel, March 18, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the fiscal year ended December 31, 2025, and provided a business and clinical update.

Company to host conference call and webcast at 8:00 a.m. EDT CARMIEL, Israel, March 11, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today announced that it will release its financial results for the fiscal year ended December 31, 2025 and provide a business update on March 18, 2026.

Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) announced that the European Commission has approved a new dosing regimen for pegunigalsidase alfa for adults with Fabry disease who are stable on enzyme replacement therapy (ERT), triggering a $25 million regulatory milestone payment from partner Chiesi Global Rare Diseases. The approval allows eligible patients to receive the therapy at a dose of 2 mg/kg every four weeks, instead of the previous every-two-weeks schedule.

This press release is intended for US audiences for transparency relative to global news for the Fabry community. This dosing regimen for Elfabrio is not approved in the US. In the US, the FDA-approved dosing regimen remains 1mg/kg every 2 weeks. Please see Important Safety Information below and the  Full Prescribing Information , including Boxed Warning.

Protalix Bio Therapeutics (PLX) received a positive CHMP opinion for Elfabrio's every-four-weeks dosing in stable adult Fabry patients, pending EC approval by March. PLX's Elfabrio could halve infusion frequency, improving patient quality of life and potentially strengthening its competitive position in the Fabry market. Elfabrio drove over half of PLX's FY24 product revenue, with sales rising and a potential $25 million milestone tied to EU approval.

Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) said on Friday that the European Medicines Agency's human medicines committee has issued a positive opinion recommending approval of an expanded dosing regimen for Elfabrio, its treatment for Fabry disease, in adult patients. The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a 2 mg/kg every-four-weeks dosing schedule for Elfabrio in adult Fabry patients who are stable on enzyme replacement therapy, following a re-examination of the application.

Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion following re-examination, which will be reviewed by the European Commission (EC), with a decision anticipated by March 2026