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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: PLX) and Chiesi Global Rare Diseases announced final results from the BRIGHT Phase III trial for PRX-102, aimed at treating Fabry disease. The trial showed that PRX-102 at 2 mg/kg every four weeks was well tolerated, with stable eGFR and lyso-Gb3 levels. Out of 30 enrolled patients, 29 completed the study, showcasing a favorable safety profile with no severe treatment-related adverse events. The companies plan to seek regulatory approvals for PRX-102, which could provide a new treatment option for Fabry patients currently on enzyme replacement therapy.
Protalix BioTherapeutics (NYSE: PLX) and Chiesi Global Rare Diseases announced the submission of a Marketing Authorization Application (MAA) for pegunigalsidase alfa (PRX-102) to the European Medicines Agency (EMA) for treating adults with Fabry disease. The MAA, validated by the EMA, includes comprehensive clinical data from various studies, including the phase III BALANCE clinical trial. This submission is seen as a significant step toward making PRX-102 available throughout the EU, pending a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP).
Protalix BioTherapeutics (NYSE American: PLX) announced two poster presentations for its investigational drug, pegunigalsidase alfa (PRX-102), at the 18th Annual WORLD Symposium 2022 from February 7-11, 2022, in San Diego, California. The presentations include:
- Safety and Efficacy of Pegunigalsidase Alfa Administered Every 4 Weeks in Patients with Fabry Disease, by Mr. Myrl D. Holida.
- Long-Term Safety and Efficacy of Pegunigalsidase Alfa: A Multicenter Extension Study, by Dr. Derralynn Hughes.
This event highlights Protalix's commitment to developing treatments for Fabry disease.
Protalix BioTherapeutics (PLX) provided its 2021 update to stockholders, reflecting on achievements amid pandemic challenges. Key highlights include regulatory progress for PRX-102, aimed at treating Fabry disease, with a BLA resubmission planned for H2 2022 and EMA MAA submission expected Q1 2022. Clinical advancements include completion of the Phase III BALANCE trial, with final data anticipated in Q2 2022. Financially, Protalix strengthened its balance sheet, raising nearly $50 million in new equity and issuing new convertible notes due 2024.
Protalix BioTherapeutics (PLX) reported its Q3 2021 financial results, highlighting a 36% revenue increase to $4.5 million compared to Q3 2020. The company is optimistic about the regulatory path for PRX-102, aimed at treating Fabry disease, with anticipated resubmission of its BLA to the FDA in H2 2022 and MAA submission to the EMA in Q1 2022. R&D expenses decreased 5% to $7.3 million. Cash reserves stood at $48.7 million, supporting operations through 2022 milestones. A net loss of $4.2 million was reported, an improvement from the previous year.
Protalix BioTherapeutics (NYSE American: PLX) will announce its third quarter 2021 financial results on November 15, 2021, at 8:30 a.m. EST. The announcement follows a conference call where management will discuss financial results and updates on corporate, clinical, and regulatory developments. Protalix is recognized for its innovative ProCellEx® system, which produces recombinant therapeutic proteins. Their first FDA-approved product is taliglucerase alfa, approved in May 2012, and they have a pipeline targeting various conditions, including Fabry disease and respiratory diseases.
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced the final dosing of the last patient in the phase III BALANCE clinical trial for pegunigalsidase alfa (PRX–102), aimed at treating Fabry disease. The study involved 78 patients, with 72 completing the two-year treatment. The BALANCE Study compares the efficacy of PRX–102 with agalsidase beta (Fabrazyme) on renal function in patients with worsening kidney disease.
As the trial concludes, 67 patients will continue with PRX–102 in a long-term extension study, indicating ongoing commitment to addressing Fabry disease treatment needs.
Protalix BioTherapeutics (PLX) and Chiesi Global Rare Diseases have shared a regulatory update on pegunigalsidase alfa (PRX–102), aimed at treating Fabry disease. The FDA's Type A meeting minutes indicate a potential pathway for resubmitting the Biologics License Application (BLA) based on positive feedback. The planned BLA resubmission will include final analyses from the phase III BALANCE trial. The companies also held discussions with the EMA regarding a Marketing Authorization Application (MAA) for PRX–102, anticipated to be submitted in Q1 2022, reinforcing their commitment to the Fabry community.
Protalix BioTherapeutics (NYSE American: PLX) has completed the exchange of $54.65 million in 2021 Senior Secured Convertible Notes for $28.75 million of new notes due in 2024, alongside $25.90 million in cash. This strategic move is aimed at advancing the resubmission of the PRX-102 BLA to the FDA and submission of the MAA to the EMA. The initial conversion price of the new notes is approximately $1.7755 per share, representing a 32.5% premium to its recent stock price. The exchanges were completed with institutional note holders, enhancing Protalix's financial flexibility.
Protalix BioTherapeutics (NYSE American: PLX) reported its Q2 2021 financial results, revealing revenues of $3.2 million—a decrease of 11% from Q2 2020. Revenue from license and R&D services fell by 56% to $3.2 million, primarily due to updated cost estimates. The company incurred a net loss of $11.2 million or $0.25 per share, compared to a net loss of $4.2 million in the same quarter last year. Protalix continues to engage with the FDA regarding PRX-102 for Fabry disease, with a meeting scheduled for September 9, 2021, and plans to submit a Marketing Authorization Application to the EMA, pending positive discussions.