Protalix BioTherapeutics, Inc. - PLX STOCK NEWS

Protalix BioTherapeutics (PLX) reported Q1 2022 financial results, showing a 100% revenue increase to $9.0 million compared to Q1 2021. The company advanced its Fabry disease treatment, PRX-102, completing three phase III trials and preparing for a BLA resubmission to the FDA. Key studies, BRIGHT and BALANCE, demonstrated significant efficacy and safety. R&D expenses rose by 24% to $8.8 million, while net loss improved to $2.3 million. The company holds $32.9 million in cash as of March 31, 2022. A conference call is scheduled for today at 8:30 a.m. EDT.

Protalix BioTherapeutics (NYSE: PLX) will release its first-quarter 2022 financial results on May 16, 2022, and host a conference call at 8:30 a.m. EDT. The call will address financials and provide updates on corporate and clinical developments. The company specializes in recombinant therapeutic proteins using its ProCellEx plant cell-based expression system, with FDA-approved products like taliglucerase alfa. Protalix is also developing several candidates targeting various diseases, including Fabry disease and respiratory conditions.

Protalix BioTherapeutics (PLX) and Chiesi Global Rare Diseases announced positive topline results from the BALANCE pivotal Phase III trial for PRX–102, a novel enzyme replacement therapy for Fabry disease. The trial, involving 78 adult patients, demonstrated non-inferiority of PRX–102 compared to agalsidase beta in slowing kidney function decline, a key outcome measure. The median eGFR slope in the PRX–102 group was -2.514 mL/min/1.73 m²/year, while the agalsidase beta group had -2.155 mL/min/1.73 m²/year. The favorable safety profile and positive results strengthen the case for regulatory submission for PRX–102's approval.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) reported its fiscal year 2021 financial results, highlighting a revenue of $16.7 million, a 3% increase from 2020. However, revenues from licenses and R&D services fell by 54%, totaling $21.6 million. The net loss for 2021 was approximately $27.6 million, or $0.62 per share, compared to a loss of $6.5 million in 2020. Notable developments include a validated Marketing Authorization Application to the EMA for PRX-102 for Fabry disease and positive preliminary results from its phase III BRIGHT clinical trial.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) will announce its fiscal year 2021 financial results and provide a business update on March 31, 2022, at 8:30 a.m. EDT. The conference call will cover recent corporate and clinical developments. Protalix, known for its ProCellEx^® plant cell-based protein expression system, aims to enhance its pipeline, which includes therapies for Fabry disease and other conditions. Investors can join the call via phone or webcast, with links provided for access.

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.