Protalix BioTherapeutics, Inc. Securities Fraud Investigation

Shamis & Gentile, P.A. is investigating claims on behalf of investors of Protalix BioTherapeutics, Inc. (PLX). Impacted investors are advised to contact the firm now.

What the Investigation Is About?

The law firm is investigating whether Protalix and certain of its officers and directors made misrepresentations or failed to disclose material information regarding the regulatory prospects and clinical efficacy of PRX-102 (Elfabrio) between February 2022 and October 16, 2025.

Throughout this period, Protalix and its management highlighted positive clinical data for the 2 mg/kg every-four-week (E4W) dosing regimen of PRX-102 and emphasized progress toward regulatory approval. The Company stated that the E4W regimen was well tolerated and maintained stable kidney function, allegedly framing the dosing schedule as a potential alternative to the approved every-two-week regimen. Management also announced milestones such as the submission and validation of applications with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

On October 17, 2025, Protalix disclosed that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the proposed E4W dosing regimen for Elfabrio.

Market Reaction

Following this news, Protalix’s stock fell 22.5%, from a closing price of $2.40 on October 16 to $1.86 on October 17, 2025, resulting in significant losses for investors.

What Investors Can Do

If you purchased or otherwise acquired Protalix (PLX) securities between February 2022 and October 16, 2025, you may be eligible to seek compensation for your losses. Contact Shamis & Gentile, P.A. today to discuss your rights.

Shamis & Gentile, P.A. stands out as an advocate for investors who are victims of securities fraud. The firm is committed to securing recoveries for investors who have incurred damages due to false and misleading statements or other corporate misconduct by public companies. Shamis & Gentile has recovered over $1 billion for consumers nationwide. Its extensive experience, expertise and resources enable the firm to resolve disputes in a wide range of matters, including class actions, mass torts and mass arbitrations.

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