Protalix Biother Stock Price, News & Analysis

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.

Protalix BioTherapeutics (NYSE American: PLX) reported Q1 2021 results, noting a revenue decline of 10% to $4.5 million, influenced by decreased sales in Brazil. License and R&D service revenues fell 59% to $6.8 million. The FDA issued a Complete Response Letter for PRX-102, though no safety or efficacy issues were identified. A $10 million milestone payment from Chiesi is expected to bolster cash flow. Cash reserves stood at $70.4 million, with a net loss of $5.5 million for the quarter. The company anticipates continued progress in clinical trials while addressing regulatory requirements.

Protalix BioTherapeutics (NYSE American: PLX) will release its first quarter 2021 financial results and provide a business update on May 14, 2021, at 8:30 a.m. EDT. The conference call will cover recent corporate and clinical developments. Protalix develops recombinant therapeutic proteins using its proprietary ProCellEx^® plant cell-based expression system, securing FDA approval for its first product, taliglucerase alfa, in May 2012. The company is advancing several product candidates targeting various diseases.

Protalix BioTherapeutics (NYSE American: PLX) announced an update regarding the Complete Response Letter (CRL) it received from the FDA for its Biologics License Application (BLA) for pegunigalsidase alfa (PRX–102) targeting Fabry disease. The CRL does not raise safety or efficacy concerns but requires an FDA inspection of Protalix's manufacturing facility before approval. The FDA plans to define a path for future inspections. Protalix aims to schedule a Type-A meeting with the FDA to discuss accelerating approval.

Protalix BioTherapeutics (NYSE American: PLX) and Chiesi Global Rare Diseases received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application for pegunigalsidase alfa (PRX-102) intended for treating Fabry disease. The companies are evaluating the regulatory feedback to outline steps for potential approval. Despite the setback, executives express confidence in their clinical data and commitment to advancing the treatment. The PRX-102 BLA was granted Priority Review by the FDA, emphasizing its potential significance in addressing unmet medical needs in Fabry patients.

Protalix BioTherapeutics (PLX) reported financial results for FY 2020, highlighting revenues of $16.2 million from sales and $46.7 million from licenses, marking increases from 2019. The net loss narrowed to $6.5 million, or $0.22 per share, compared to a loss of $18.3 million in 2019. The company advanced its clinical trials, notably for PRX–102, with a significant PDUFA date set for April 27, 2021. Protalix also secured funding through a $40.2 million public offering in February 2021, strengthening its financial position to support upcoming milestones.

Protalix BioTherapeutics, Inc. (NYSE American: PLX) will release its fiscal year 2020 financial results and provide a business update on March 30, 2021, at 8:30 a.m. EDT. The company will host a conference call to discuss recent corporate and clinical developments. Protalix specializes in recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx. The call will be accessible via domestic and international numbers, and will be webcast live on the company's website.