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Protalix BioTherapeutics, Inc. develops, manufactures and commercializes recombinant therapeutic proteins for rare diseases using its proprietary plant cell-based expression system, ProCellEx®. The company’s recurring news includes financial results, business updates, regulatory developments for Elfabrio® in Fabry disease, and commercial or partnership activity tied to approved enzyme replacement therapies.
Company updates also cover pipeline programs such as PRX-115, a recombinant PEGylated uricase candidate for uncontrolled gout, and PRX-119, a long-acting DNase I program associated with rare kidney disease research. Protalix also reports on collaborations involving RNA-based therapeutic discovery and on its licensed relationship with Pfizer for taliglucerase alfa, Elelyso®, for Gaucher disease outside Protalix-retained rights in Brazil.
Protalix BioTherapeutics (NYSE American: PLX) reflects on its significant achievements in 2022 in a letter to shareholders. The company, in collaboration with Chiesi, has submitted marketing applications for its Fabry disease treatment PRX-102 to both the FDA and EMA, with the latter under review. The FDA has set a decision date of May 9, 2023. Additionally, Protalix is progressing with PRX-115 for severe gout, showing promising preclinical results. The firm expresses optimism for continued growth in 2023, underscoring the potential market for PRX-102 and ongoing pipeline developments.
Protalix BioTherapeutics (NYSE American: PLX) will voluntarily delist its common stock from the Tel Aviv Stock Exchange (TASE) to focus on trading on the NYSE American. This decision is expected to streamline operations, reducing costs and regulatory compliance. The delisting process will begin immediately, with an expected completion time of three months. During this transition, PLX shares will continue to trade on the TASE and will eventually transfer to the NYSE American. The company remains committed to complying with U.S. SEC regulations and will provide further updates on the delisting timeline.
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.