Welcome to our dedicated page for Protalix BioTherapeutics news (Ticker: PLX), a resource for investors and traders seeking the latest updates and insights on Protalix BioTherapeutics stock.
Protalix BioTherapeutics, Inc. (NYSE: PLX) is a clinical-stage biopharmaceutical company specializing in the development and commercialization of recombinant therapeutic proteins. The company leverages its proprietary ProCellEx® plant cell-based protein expression system, a novel method for producing recombinant proteins at an industrial scale.
Core Business: Protalix's main focus is developing therapeutic proteins for various diseases. Its flagship product, Taliglucerase Alfa, is an enzyme replacement therapy for Gaucher disease. This product has completed Phase III studies and is currently under FDA review, with treatment ongoing for numerous patients worldwide. Additionally, Taliglucerase Alfa has been licensed to Pfizer, excluding the Brazilian market, where Protalix retains full rights.
Protalix's second major product, Elfabrio®, was approved by both the U.S. FDA and the European Medicines Agency in May 2023. Developed in partnership with Chiesi Farmaceutici S.p.A., Elfabrio is a PEGylated enzyme replacement therapy for Fabry disease. Chiesi is actively marketing Elfabrio globally, having received approvals in multiple regions, including the U.S., EU, UK, Switzerland, and Israel.
Pipeline: Protalix has a robust pipeline featuring numerous proprietary therapeutic protein candidates:
- PRX-115: A plant cell-expressed recombinant PEGylated uricase for treating severe gout, currently in a Phase I clinical trial.
- PRX-119: A plant cell-expressed long-acting DNase I intended for NETs-related diseases, in preclinical development.
- Other early-stage assets targeting various medical conditions.
Financial Condition: Protalix has shown financial resilience, supported by revenue from product sales and milestone payments. In 2023, the FDA approval of Elfabrio triggered a $20 million milestone payment from Chiesi, adding to the company's revenue stream. Protalix's strong balance sheet positions it well for ongoing operations and future growth.
Partnerships: Protalix has strategic partnerships with industry leaders like Pfizer and Chiesi Farmaceutici S.p.A., enhancing its global reach and market penetration. These collaborations are pivotal in driving the development and commercialization of its therapeutic products.
Recent Updates: Protalix remains committed to its mission despite the current security situation in Israel. The company's operations remain unaffected, ensuring a steady supply of its critical therapies. Protalix continues to host regular investor calls and webcasts to provide updates on financial performance and clinical progress.
Chiesi Global Rare Diseases and Protalix BioTherapeutics (PLX) announced the European Medicines Agency's validation of their Variation Submission for pegunigalsidase alfa. The submission aims to approve a less frequent dosing regimen of 2 mg/kg every four weeks for adult Fabry disease patients, compared to the current 1 mg/kg every two weeks.
The application is supported by a revised Population-PK model, exposure-response analyses, and clinical data from the Phase 3 BRIGHT study and its ongoing extension study. The studies investigated the 2 mg/kg every four weeks dosing in adult Fabry disease patients previously treated with agalsidase-alfa or -beta.
Protalix BioTherapeutics (PLX) reported Q3 2024 financial results with revenues from goods of $17.8 million, a 75% increase from Q3 2023. The company achieved net income of $3.2 million ($0.04 per share basic). Key highlights include completion of all eight cohorts in the PRX-115 phase I trial for uncontrolled gout treatment, showing promising preliminary results with sustained uric acid reduction. Cash position stands at $27.4 million as of September 30, 2024. The company fully repaid its 7.50% Senior Secured Convertible Notes and plans to initiate a phase II clinical trial for PRX-115 in the second half of 2025.
Protalix BioTherapeutics (PLX) has scheduled the release of its third quarter 2024 financial results and business update for November 14, 2024. The company will host a conference call and webcast at 8:30 a.m. EST to discuss financial results and provide updates on corporate and regulatory developments. The event will be accessible via toll-free numbers for domestic and international callers, with a Call me™ feature available for immediate connection. A two-week replay will be available on the company's website.
Protalix BioTherapeutics (NYSE American:PLX) announced it will present data from its phase I clinical trial of PRX-115, a recombinant PEGylated uricase product candidate for uncontrolled gout treatment, at the ACR Convergence 2024. The presentation, titled 'Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115,' will be delivered as a late-breaking poster on November 18, 2024. The study focuses on participants with elevated urate levels, and the results will be presented by Dr. Orit Cohen Barak from Protalix.
Protalix BioTherapeutics (NYSE American: PLX), a biopharmaceutical company specializing in recombinant therapeutic proteins, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel in New York City.
Company President and CEO Dror Bashan will deliver a presentation on Wednesday, September 11, at 12:30 p.m. EDT in the Holmes II Room on the Fourth floor. The management team will also engage in one-on-one meetings with registered investors throughout the conference.
Protalix is known for its proprietary ProCellEx® plant cell-based protein expression system, which is used in the development and production of recombinant therapeutic proteins.
Protalix BioTherapeutics (NYSE American: PLX) has announced the full repayment of its 7.50% Senior Secured Convertible Promissory Notes, marking a significant milestone for the company. The repayment was financed entirely with available cash, resulting in Protalix becoming debt-free with no outstanding notes. This move has eliminated the potential equity overhang presented by the notes and strengthened the company's balance sheet.
CEO Dror Bashan highlighted that the company's financial discipline has led to a strong financial position, providing sufficient runway for planned ongoing operations. Protalix, a biopharmaceutical company specializing in recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, had previously relied on convertible notes for financing, with the total outstanding principal amount reaching $78.0 million at its peak.
Protalix BioTherapeutics (NYSE American: PLX) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Revenues from selling goods decreased 12% to $13.3 million
- License and R&D services revenue fell 99% to $0.2 million
- Net loss of $2.2 million ($0.03 per share) compared to net income of $19.3 million in Q2 2023
- Cash position of $45 million as of June 30, 2024
- Positive topline results from Phase I trial of PRX-115 for uncontrolled gout
- Preparations initiated for Phase II trial of PRX-115
The company's pipeline progress and strong balance sheet position it to repay convertible notes due September 2024 while maintaining operations.
Protalix BioTherapeutics (NYSE American: PLX) has announced that it will release its financial results for the second quarter of 2024 on August 14, 2024. The company, which specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based protein expression system, will also provide a business and clinical update during a conference call with investors.
The conference call is scheduled for 8:30 a.m. EDT on August 14, 2024. Investors can join via toll-free numbers for US and Israeli participants, or through an international line. A webcast of the call will also be available, and a replay will be accessible for two weeks on the company's website.
Protalix BioTherapeutics (NYSE American: PLX), a biopharmaceutical firm, will host an in-person investor day on June 26, 2024, at the Lotte Palace New York Hotel. The event will begin at 8:30 a.m. EDT. Key opinion leaders, including Aleš Linhart of Charles University and Naomi Schlesinger of the University of Utah, will discuss the treatment landscapes for Fabry disease and uncontrolled gout, respectively. Special focus will be on clinical results for Elfabrio® (pegunigalsidase alfa) and PRX-115. Protalix's CEO, Dror Bashan, will also present a corporate overview. A live Q&A session will follow the presentations.
Protalix BioTherapeutics (NYSE American: PLX), a biopharmaceutical company specializing in recombinant therapeutic proteins via its ProCellEx® plant cell-based system, announced its participation at the 2024 BIO International Convention in San Diego, California. The convention, hosted by the Biotechnology Innovation Organization (BIO), is the largest industry event, gathering global biotech and biopharmaceutical executives. Dror Bashan, President and CEO of Protalix, will present on June 3, 2024, at 2:30 PM PDT in Theater 1, providing updates on corporate developments to industry leaders and investors.
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