Welcome to our dedicated page for Protalix Biother news (Ticker: PLX), a resource for investors and traders seeking the latest updates and insights on Protalix Biother stock.
News and updates for Protalix BioTherapeutics, Inc. (PLX) center on its activities as a biopharmaceutical company focused on rare disease therapeutics and recombinant proteins produced with its proprietary ProCellEx® plant cell-based expression system. This page aggregates company press releases, financial announcements and clinical program updates that reflect how Protalix is developing and commercializing enzyme replacement therapies and advancing its pipeline.
Investors and followers of PLX can find coverage of commercial performance for the company’s approved products, including Elfabrio® for Fabry disease and Elelyso® (taliglucerase alfa) for Gaucher disease, supplied to partners such as Chiesi, Pfizer and Fiocruz in Brazil. News items also describe how these established revenue streams support Protalix’s research and development efforts.
Another key theme in Protalix news is pipeline progress. The company regularly reports on PRX–115, a plant cell-expressed recombinant PEGylated uricase for uncontrolled gout, including Phase 1 data and regulatory milestones like the submission of an IND to the FDA for a planned Phase 2 trial. Updates also cover PRX–119, a long-acting DNase I candidate for NETs-related and rare renal diseases, and the company’s collaboration with Secarna Pharmaceuticals to discover antisense oligonucleotide therapies for rare kidney indications.
Regulatory and corporate developments appear frequently in PLX news, such as EMA evaluations of new dosing regimens for Elfabrio, inclusion in the Russell 3000® and 2000® Indexes, at-the-market equity program amendments, executive appointments and outcomes of stockholder meetings or legal matters. Bookmark this page to follow how Protalix’s commercial partnerships, clinical trials and strategic collaborations evolve over time.
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.