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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.
Protalix BioTherapeutics (NYSE: PLX) and Chiesi Global Rare Diseases announced the FDA's acceptance of the resubmitted Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) aimed at treating adult patients with Fabry disease. The BLA, deemed a complete class 2 response, has a set action date of May 9, 2023. This submission includes comprehensive clinical data from over 140 patients over five years, covering studies from the Phase III clinical program. If approved, Protalix stands to receive a milestone payment from Chiesi.
Protalix BioTherapeutics (NYSE: PLX) announced a key opinion leader (KOL) webinar on Fabry Disease and its treatment candidate PRX-102, scheduled for December 5, 2022, at 8:30 a.m. EST. The webinar will be led by Myrl D. Holida from the University of Iowa, discussing the robust clinical program for PRX-102. This event aims to engage healthcare professionals with insights on this potential treatment. Protalix’s pipeline includes other therapeutic candidates targeting various diseases, leveraging its proprietary ProCellEx plant cell-based expression system.
Protalix BioTherapeutics (NYSE American: PLX) reported a significant business update and financial results for Q3 2022, noting a 96% increase in revenue from goods sold, totaling $8.8 million. The company resubmitted a biologics license application for PRX-102, aimed at treating Fabry disease, incorporating updated clinical trial data. R&D expenses slightly rose to $7.4 million, while net loss decreased to $3.6 million. The company maintains cash reserves of approximately $20.8 million as of Sept 30, 2022, highlighting ongoing efforts in advancing their therapy pipeline.
Protalix BioTherapeutics (NYSE American: PLX) announced the resubmission of a Biologics License Application (BLA) for PRX–102 to the FDA on November 9, 2022. This application aims to treat adult patients with Fabry disease, a rare genetic disorder. The BLA includes extensive clinical data from over 140 patients over five years, covering Phase III studies. If approved, Protalix could receive a milestone payment from Chiesi Global Rare Diseases. The FDA is expected to complete its review within six months, with ongoing EMA discussions for marketing approval in Europe.
Protalix BioTherapeutics, a biopharmaceutical company, will release its third quarter 2022 financial results and a business update on November 14, 2022. A conference call will take place at 8:30 a.m. EST to discuss these results and recent corporate developments. Investors can access the call via a toll-free number or a live webcast through the company’s website. Protalix specializes in recombinant therapeutic proteins manufactured using its proprietary ProCellEx system and has a diverse pipeline targeting significant pharmaceutical markets.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced that President and CEO Dror Bashan will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 11:00 a.m. EDT in New York City. The conference runs from September 12-14, 2022, and includes options for virtual participation. A live corporate overview will be webcast, replacing a prior pre-recorded presentation. Management will also engage in one-on-one investor meetings during the event.
Protalix specializes in recombinant therapeutic proteins through its ProCellEx® expression system.
Protalix BioTherapeutics (NYSE American: PLX) announced its participation at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, at the Lotte New York Palace Hotel. CEO Dror Bashan will present a corporate overview, and a live webcast will start at 7:00 AM ET on September 12. Protalix specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® system. The company has FDA approval for its first product, taliglucerase alfa, and is advancing several therapeutic candidates for various diseases.
Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced its Q2 2022 financial results and business updates on August 15, 2022. The firm reported revenues of $3.4 million from goods, a 6% increase year-over-year, and $5.4 million from licenses and R&D services, a 69% increase. The cost of goods sold decreased by 13% to $4.1 million. Research expenses slightly fell by 1% to $7.6 million, while SG&A expenses dropped by 19% to $2.6 million. The net loss narrowed to approximately $5.3 million, down from $11.2 million in Q2 2021. Protalix confirmed positive results from the phase III BALANCE trial for PRX-102.
Protalix BioTherapeutics (NYSE American: PLX) will announce its second-quarter 2022 financial results and provide a business update on August 15, 2022. A conference call with investors is scheduled for the same day at 8:30 a.m. EDT, where management will discuss financial results and recent corporate updates. Protalix is known for its ProCellEx protein expression system and has FDA-approved products, including taliglucerase alfa. The company has a strong pipeline targeting various medical conditions.
Protalix BioTherapeutics (NYSE American: PLX) has appointed Shmuel 'Muli' Ben Zvi, Ph.D., to its Board of Directors. Dr. Ben Zvi, who brings extensive financial and management expertise, will also serve on the Audit and Compensation Committees. His prior experience includes senior roles at Teva Pharmaceuticals and positions on various boards including Bank Leumi. Protalix is known for its innovative plant cell-based expression system and has FDA-approved products, ensuring its commitment to developing recombinant therapeutic proteins.
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