Protalix Biother Stock Price, News & Analysis

Chiesi Global Rare Diseases and Protalix BioTherapeutics (NYSE: PLX) have launched an Expanded Access Program (EAP) in the U.S. for pegunigalsidase alfa, aimed at treating Fabry disease. This initiative enables broader patient access to the investigational drug, currently under FDA review through a Biologics License Application (BLA). The EAP targets patients with Fabry disease who lack satisfactory treatment options. Treatment will involve bi-weekly infusions of pegunigalsidase alfa, with data collected on adverse events. The drug's safety and effectiveness have yet to be established by the FDA.

Protalix BioTherapeutics (NYSE American: PLX) announced on September 3, 2020, that it has regained compliance with all continued listing standards of the NYSE American. This follows a deficiency notification received on August 26, 2019. The company met the $50 million market capitalization exemption, allowing it to continue trading without restrictions. Protalix is known for its plant cell-based protein expression system, ProCellEx, and its investigational drug, pegunigalsidase alfa, is under review by the FDA for Fabry disease treatment.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced that its CEO, Dror Bashan, will present at the H.C. Wainwright 22nd Annual Global Investment Virtual Conference on September 15, 2020, at 12:00 PM ET. This virtual event runs from September 14-16, 2020. A live webcast of the presentation will be available on Protalix's website, with a replay accessible for at least 15 days afterward. Protalix specializes in recombinant therapeutic proteins through its ProCellEx® plant-based expression system, which has FDA-approved products including taliglucerase alfa.

Protalix BioTherapeutics (NYSE American: PLX) has completed the treatment period of its Phase III BRIGHT clinical trial for pegunigalsidase alfa (PRX–102) aimed at treating Fabry disease. The company is finalizing the data analysis process amid COVID-19 restrictions and expects to announce top-line results in Q4 2020. This trial follows positive results from the earlier Phase III BRIDGE trial. Additionally, Protalix has filed a BLA for PRX–102 with the FDA, targeting a PDUFA date of January 27, 2021, marking significant progress in their drug development pipeline.

Protalix BioTherapeutics (PLX) announced that the FDA has accepted its Biologics License Application (BLA) for pegunigalsidase alfa and granted it Priority Review for treating Fabry disease. The FDA set a decision date for January 27, 2021, under the Accelerated Approval pathway. The submission includes data from completed Phase I/II trials and ongoing studies of PRX-102. This designation significantly shortens the review period, indicating potential for substantial benefits in treating serious conditions. The company aims to establish a new treatment option for Fabry patients.

Protalix BioTherapeutics (NYSE American: PLX) reported its Q2 2020 financial results, highlighting significant milestones despite COVID-19 challenges. The company announced positive topline results from its BRIDGE Phase III trial of PRX–102 for Fabry disease and submitted a Biologics License Application (BLA) to the FDA. Q2 revenues reached $10.9 million, a 12% year-on-year decrease mainly due to lower R&D revenues. Research expenses fell by 31% to $9.2 million. Protalix remains financially stable with $4.8 million in cash and $35.2 million in bank deposits, indicating a solid foundation for future growth.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) announced its participation in the BTIG Virtual Biotechnology Conference on August 10-11, 2020. Dror Bashan, the CEO, will present in a fireside chat format on August 10 at 2:00 PM ET. The presentation can be viewed live on the company’s website and will be available for replay for 15 days. Protalix is known for its proprietary ProCellEx® system for producing therapeutic proteins and has a pipeline targeting diseases like Fabry disease and cystic fibrosis.

Protalix BioTherapeutics (NYSE: PLX) announced it will release its second quarter 2020 financial results and business update on August 10, 2020, at 8:30 a.m. EDT. A conference call with management will follow to discuss the results. Protalix, known for its ProCellEx® plant cell-based protein expression system, has developed recombinant therapeutic proteins, including taliglucerase alfa. The company has ongoing partnerships for product development, notably with Chiesi Farmaceutici for pegunigalsidase alfa aimed at Fabry disease.

Protalix BioTherapeutics (NYSE American: PLX) announced a non-binding term sheet with SarcoMed USA for the development of PRX-110 (alidornase alfa) targeting Pulmonary Sarcoidosis. This follows the FDA granting Orphan Drug Designation to alidornase alfa for the treatment of this rare disease on July 21, 2020. Protalix, known for its ProCellEx® plant-based protein expression system, seeks to advance its pipeline that includes various recombinant therapeutic proteins. The company has previously collaborated with Pfizer for another product, taliglucerase alfa.