Protalix BioTherapeutics

PLX

Market cap $232M

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

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

Protalix Biotherapeutics Inc (NYSE-A:PLX) on Monday shared an update from its CEO Dror Bashan, who highlighted the company's strategic priorities for 2026, with a focus on advancing its clinical pipeline while building on its partnered commercial base. In a letter to stockholders, Bashan wrote that Protalix remains focused on “building with our partners a growing, profitable business and an innovative pipeline for patients with high-need rare diseases.

CARMIEL, Israel, Jan. 5, 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 the following update from President and Chief Executive Officer, Dror Bashan, to its stockholders. Dear Protalix Stockholders, As we look forward to 2026, we remain focused on building with our partners a growing, profitable business and an innovative pipeline for patients with high-need rare diseases.

Protalix Biotherapeutics Inc (NYSE-A:PLX) announced that it has entered into a collaboration and option agreement with Secarna Pharmaceuticals to jointly develop new antisense oligonucleotide (ASO) therapies targeting rare kidney diseases, the companies said Tuesday. Secarna, headquartered in Martinsried, Germany, specializes in the discovery and development of oligonucleotide-based therapeutics.

Partnership combines Protalix's rare disease and biologics expertise with Secarna's AI–powered OligoCreator® platform to jointly develop pharmaceutical candidates for rare renal indications Protalix is granted an exclusive option to license any active compounds derived from the research for potential clinical development and commercialization CARMIEL, Israel and MARTINSRIED, Germany , Dec. 17, 2025 /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, and Secarna Pharmaceuticals GmbH & Co. KG, a company redefining the discovery and development of best-in-class oligonucleotide therapeutics, today announced that they have entered into a collaboration and option agreement. Under this agreement, the companies have agreed to partner in the discovery of novel antisense oligonucleotide (ASO) therapies against multiple targets for rare renal indications.

Protalix BioTherapeutics, Inc. ( PLX ) Q3 2025 Earnings Call November 13, 2025 8:00 AM EST Company Participants Mike Moyer Dror Bashan - President, CEO & Director Gilad Mamlok - Senior VP & CFO Conference Call Participants Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division John Vandermosten - Zacks Small-Cap Research Presentation Operator Greetings, and welcome to the Protalix BioTherapeutics Third Quarter Financial and Business Results Conference Call.

Company to host conference call and webcast today at 8:00 a.m. EST CARMIEL, Israel , Nov. 13, 2025 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the quarter ended September 30, 2025, and provided a financial and business update.