Protalix BioTherapeutics, Inc. - PLX STOCK NEWS

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.

Protalix BioTherapeutics (PLX) has entered into Exchange Agreements to exchange $54.65 million of its existing 7.50% Senior Secured Convertible Notes due 2021 for $28.75 million of new notes due 2024 and $25.90 million in cash. This initiative aims to optimize the company’s capital structure and support the ongoing development of its lead drug, PRX-102. Approximately $3.27 million of existing notes will still be outstanding post-exchange. Institutional investors backing the exchange reflect confidence in Protalix's strategic direction.

Protalix BioTherapeutics (NYSE American: PLX) announced its financial results release for Q2 2021 on August 16, 2021, followed by a conference call at 8:30 a.m. EDT. The call will discuss financial outcomes and recent corporate and clinical updates. Protalix focuses on developing recombinant therapeutic proteins via its ProCellEx^® system. The company is known for its FDA-approved product, taliglucerase alfa, and has several products in its pipeline, including pegunigalsidase alfa for Fabry disease and OPRX-106 for anti-inflammatory treatment.

Protalix BioTherapeutics (NYSE American: PLX) announced on August 2, 2021, that it submitted a Type A Meeting request to the FDA. This follows the Complete Response Letter (CRL) received on April 27, 2021, regarding the Biologics License Application (BLA) for its treatment, pegunigalsidase alfa (PRX-102), for Fabry disease. The meeting is anticipated within 30 days of the FDA's receipt of the request, aimed at clarifying the next steps for the BLA process.

Protalix BioTherapeutics (NYSE American: PLX) announced a virtual fireside chat on June 30, 2021, featuring CEO Dror Bashan and CFO Eyal Rubin, hosted by Zacks Investment Research. The event begins at 9:00 a.m. EDT, with a webcast available for investors. Protalix specializes in developing therapeutic proteins using its proprietary ProCellEx® expression system, having received FDA approval for its first product in May 2012. The company has a robust pipeline targeting various diseases, including Fabry disease and respiratory conditions.

Protalix BioTherapeutics (PLX) and Chiesi Global Rare Diseases announced updates on the clinical development of pegunigalsidase alfa (PRX–102) for Fabry disease. Currently in a Phase III BALANCE trial, PRX–102 shows promising interim results with 78 patients enrolled. The interim efficacy analysis indicates favorable safety data, with no deaths reported. Protalix intends to submit a Marketing Authorization Application (MAA) to the EMA, aiming for regulatory approval in both the EU and the U.S. after further clinical assessments.