Protalix and Chiesi seek EMA re-examination of Elfabrio dosing opinion
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they have requested a re-examination of a recent negative opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning a new dosing regimen for Elfabrio. The CHMP's opinion relates to a proposal to add a 2 mg/kg every-four-weeks (E4W) dosing option to the currently approved 1 mg/kg every-two-weeks (E2W) regimen for the treatment of adults with Fabry disease.
Protalix, Chiesi reaffirm commitment to Fabry disease patients after EMA panel setback
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they remain committed to advancing treatment options for Fabry disease after a European Medicines Agency committee declined to recommend approval of a new, less frequent dosing regimen for Elfabrio (pegunigalsidase alfa). The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the proposed dosing schedule of 2 mg/kg every four weeks, in addition to the already approved 1 mg/kg every two weeks regimen.
Protalix: Speculative Buy On Promising Plant-Cell Platform And Elfabrio Ramp
Protalix BioTherapeutics uses a plant-cell approach with ProCellEx. This has given it two approved ERTs plus PRX-115 and PRX-119. Its main focus is on a growing rare-disease pipeline. The main value driver is Elfabrio, which targets Fabry's rapidly growing TAM. PLX's valuation multiples also look compelling, especially after the stock retraced significantly in the last few weeks.
Protalix BioTherapeutics, Inc. (PLX) Q2 2025 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q2 2025 Earnings Call August 14, 2025 8:30 AM ET Company Participants Dror Bashan - President, CEO & Director Eyal Rubin - Senior VP, CFO, Treasurer & Corporate Secretary Conference Call Participants Daniel Robert Smith - H.C. Wainwright & Co, LLC, Research Division John D.
Protalix BioTherapeutics lifts revenue on strong Elfabrio demand
Protalix Biotherapeutics Inc (NYSE-A:PLX) reported higher quarterly revenue and reaffirmed its long-term growth outlook on Thursday, pointing to expanding demand for its Fabry disease treatment Elfabrio and upcoming clinical milestones for its pipeline. The Israeli biopharmaceutical company said revenue from selling goods rose 16% to $15.4 million in the quarter ended June 30, driven largely by increased sales of Elfabrio to Italian drugmaker Chiesi.
Protalix BioTherapeutics welcomes new finance chief
Protalix BioTherapeutics Inc (NYSE-A:PLX) has announced the appointment of Gilad Mamlok as senior vice president and chief financial officer, succeeding Eyal Rubin. Mamlok has already joined the company and is currently working alongside Rubin, the company said.
Protalix BioTherapeutics joins Russell 3000 and 2000 indexes following annual reconstitution
Protalix Biotherapeutics Inc (NYSE-A:PLX) announced that it has been added to the Russell 3000 and Russell 2000 Indexes, effective after the US market closed on Friday, June 27. The inclusion follows the annual reconstitution of the Russell indexes by global index provider FTSE Russell.
Protalix BioTherapeutics, Inc. (PLX) Q1 2025 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q1 2025 Earnings Conference Call May 9, 2025 8:30 AM ET Company Participants Mike Moyer – Investor Relations Dror Bashan – President and Chief Executive Officer Eyal Rubin – Senior Vice President and Chief Financial Officer Conference Call Participants John Vandermosten – Zacks Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2025 Financial and Business Results Conference Call. As a reminder, this conference is being recorded.
Protalix eyes Phase II gout trial later this year following solid Q1 revenue growth
Protalix Biotherapeutics Inc (NYSE-A:PLX) said it is on track to launch a Phase II clinical trial of its experimental gout treatment PRX-115 later this year, as the company builds on momentum from positive early-stage results and rising product sales. The Israeli biopharmaceutical firm reported first-quarter revenues from product sales of $10 million, up 170% from a year earlier, driven largely by higher sales to Pfizer and Brazil's Fiocruz.
Protalix BioTherapeutics Is A Strong Buy With Increasing Revenues And A Promising Pipeline
Protalix BioTherapeutics is rated a Strong Buy due to stable income, profitability, and potential from pipeline programs PRX-115 and PRX-119. Elelyso and Elfabrio provide recurring revenue, with increasing royalties expected, and the company has achieved a debt-free status and profitability. PRX-115 shows promise for gout treatment, potentially outperforming KRYSTEXXA, while PRX-119 targets NETs but remains speculative.
Protalix Biotherapeutics chairman discusses breakthrough in gout treatment, drug pipeline - ICYMI
Protalix Biotherapeutics Inc (NYSE-A:PLX) chairman Eliot Forster joined Proactive to discuss the company's unique approach to drug manufacturing using plant cells instead of mammalian cells. He explained that this method enhances purity, sustainability, and reproducibility, setting Protalix apart in the biotech space.
Protalix Biotherapeutics gains momentum: analysts see long-term upside
Protalix Biotherapeutics Inc (NYSE-A:PLX) reported increased product revenues for 2024, driven by higher sales of its Fabry disease treatment, Elfabrio, to partner Chiesi Rare Disease. The company's improving financial position and revenue outlook have analysts projecting further upside following the release of its full year 2024 results.
