Protalix BioTherapeutics, Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Protalix BioTherapeutics, Inc. (PLX)

If you purchased or acquired Protalix BioTherapeutics securities and suffered losses during the relevant period, you may be eligible to join this securities investigation and seek compensation.

About Protalix BioTherapeutics

Protalix BioTherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins. One of its key products is PRX-102 (Elfabrio), a therapy developed for the treatment of Fabry disease.

The company has partnered with Chiesi Global Rare Diseases to pursue regulatory approvals and commercialization of Elfabrio in multiple regions, including the United States and Europe.

Potential Concerns Under Investigation

Attorneys are reviewing whether Protalix and its management made false or misleading statements or failed to disclose material information about the regulatory outlook and efficacy of PRX-102’s every-four-week (E4W) dosing regimen for Fabry disease.

In February 2022, Protalix announced the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for PRX-102, noting that the filing included Phase III BRIGHT trial data showing that the every-four-week regimen was well tolerated and maintained stable kidney function in treated patients.

Throughout 2023 and 2024, Protalix allegedly continued to highlight the commercial potential of PRX-102 and to reference positive regulatory updates. In December 2024, Protalix announced that the EMA had “validated” its variation submission for the E4W dosing and stated that the application remained under review. These communications allegedly maintained a positive tone until October 2025, when the regulatory outcome changed.

On October 17, 2025, Protalix disclosed that the CHMP had issued a negative opinion on the E4W dosing regimen. This was potentially the first public indication that the alternative dosing approach had failed regulatory review.

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

Your Rights and Next Steps

This is an ongoing investigation and not a filed lawsuit. Investors who purchased or otherwise acquired Protalix securities during the relevant period and suffered losses may have legal rights. If evidence shows that investors were misled, the matter could lead to a class action lawsuit seeking recovery for affected shareholders.

Lawyers are available to help investors review their options and determine eligibility. There is no cost or obligation to join the investigation, and participation is confidential.

You May Be Entitled to Compensation

If you purchased or otherwise acquired Protalix BioTherapeutics securities between February 2022 and October 16, 2025, you may be eligible to receive compensation through any potential class action. The investigation is ongoing, and time is of the essence for investors who wish to protect their rights.

To find out if you qualify and to join the investigation, complete the form below.