Protalix Biother Stock Price, News & Analysis

Protalix BioTherapeutics (PLX) released its 2025 stockholder letter highlighting key achievements in 2024 and future outlook. The company reports significant progress in its partnership with Chiesi Global Rare Diseases, including EMA's validation of a variation submission for pegunigalsidase alfa to enable less frequent dosing for Fabry disease patients. PLX completed a phase I trial for PRX-115 for uncontrolled gout, with plans to advance to phase II in H2 2025.

The company reports growth in sales across its three revenue streams: Elfabrio® to Chiesi, Elelyso® to Pfizer, and Uplyso® to Brazil. Notably, PLX has achieved debt-free status by fully repaying all outstanding convertible notes. Despite regional conflicts in Israel, operations remain uninterrupted, and the company maintains its focus on R&D in renal rare diseases using its ProCellEx platform.

Chiesi Global Rare Diseases and Protalix BioTherapeutics (PLX) announced the European Medicines Agency's validation of their Variation Submission for pegunigalsidase alfa. The submission aims to approve a less frequent dosing regimen of 2 mg/kg every four weeks for adult Fabry disease patients, compared to the current 1 mg/kg every two weeks.

The application is supported by a revised Population-PK model, exposure-response analyses, and clinical data from the Phase 3 BRIGHT study and its ongoing extension study. The studies investigated the 2 mg/kg every four weeks dosing in adult Fabry disease patients previously treated with agalsidase-alfa or -beta.

Protalix BioTherapeutics (PLX) reported Q3 2024 financial results with revenues from goods of $17.8 million, a 75% increase from Q3 2023. The company achieved net income of $3.2 million ($0.04 per share basic). Key highlights include completion of all eight cohorts in the PRX-115 phase I trial for uncontrolled gout treatment, showing promising preliminary results with sustained uric acid reduction. Cash position stands at $27.4 million as of September 30, 2024. The company fully repaid its 7.50% Senior Secured Convertible Notes and plans to initiate a phase II clinical trial for PRX-115 in the second half of 2025.

Protalix BioTherapeutics (PLX) has scheduled the release of its third quarter 2024 financial results and business update for November 14, 2024. The company will host a conference call and webcast at 8:30 a.m. EST to discuss financial results and provide updates on corporate and regulatory developments. The event will be accessible via toll-free numbers for domestic and international callers, with a Call me™ feature available for immediate connection. A two-week replay will be available on the company's website.

Protalix BioTherapeutics (NYSE American:PLX) announced it will present data from its phase I clinical trial of PRX-115, a recombinant PEGylated uricase product candidate for uncontrolled gout treatment, at the ACR Convergence 2024. The presentation, titled 'Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115,' will be delivered as a late-breaking poster on November 18, 2024. The study focuses on participants with elevated urate levels, and the results will be presented by Dr. Orit Cohen Barak from Protalix.

Protalix BioTherapeutics (NYSE American: PLX), a biopharmaceutical company specializing in recombinant therapeutic proteins, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel in New York City.

Company President and CEO Dror Bashan will deliver a presentation on Wednesday, September 11, at 12:30 p.m. EDT in the Holmes II Room on the Fourth floor. The management team will also engage in one-on-one meetings with registered investors throughout the conference.

Protalix is known for its proprietary ProCellEx® plant cell-based protein expression system, which is used in the development and production of recombinant therapeutic proteins.

Protalix BioTherapeutics (NYSE American: PLX) has announced the full repayment of its 7.50% Senior Secured Convertible Promissory Notes, marking a significant milestone for the company. The repayment was financed entirely with available cash, resulting in Protalix becoming debt-free with no outstanding notes. This move has eliminated the potential equity overhang presented by the notes and strengthened the company's balance sheet.

CEO Dror Bashan highlighted that the company's financial discipline has led to a strong financial position, providing sufficient runway for planned ongoing operations. Protalix, a biopharmaceutical company specializing in recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, had previously relied on convertible notes for financing, with the total outstanding principal amount reaching $78.0 million at its peak.

Protalix BioTherapeutics (NYSE American: PLX) reported Q2 2024 financial results and provided a business update. Key highlights include:

- Revenues from selling goods decreased 12% to $13.3 million

- License and R&D services revenue fell 99% to $0.2 million

- Net loss of $2.2 million ($0.03 per share) compared to net income of $19.3 million in Q2 2023

- Cash position of $45 million as of June 30, 2024

- Positive topline results from Phase I trial of PRX-115 for uncontrolled gout

- Preparations initiated for Phase II trial of PRX-115

The company's pipeline progress and strong balance sheet position it to repay convertible notes due September 2024 while maintaining operations.

Protalix BioTherapeutics (NYSE American: PLX) has announced that it will release its financial results for the second quarter of 2024 on August 14, 2024. The company, which specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based protein expression system, will also provide a business and clinical update during a conference call with investors.

The conference call is scheduled for 8:30 a.m. EDT on August 14, 2024. Investors can join via toll-free numbers for US and Israeli participants, or through an international line. A webcast of the call will also be available, and a replay will be accessible for two weeks on the company's website.