Why Protalix Bio Therapeutics, PLX Stock Surged by 46.67% Pre-Market?

PLX Stock Surged: Excitement for Premarket hours are rising up among the players of the share market as the market is about to opens after April’s first weekend. As of now the hottest share in the entire market is Protalix (NYSE: PLX), a biotech company developing mostly therapeutic proteins. PLX is soaring 46.67% on more than 3 million shares.

PLX Stock Surged – All thanks to successful clinical trials of PRX-102

Clinical trials of PRX-102 have been going on for 24 months and the phase 3 of this trial has shown some positive results in treating Fabry disease. Einat Brill Almon who is Protalix’s Chief Development Officer also commented over the trial that: “Given these results, we plan, together with Chiesi, our commercialization partner, to work with regulatory agencies on the applicable submissions, hopefully bringing PRX–102 to approval as a new PEGylated enzyme replacement therapy for all adult Fabry patients”

Experts predicted that if the PRX-102’s clinical trails gets successful and it gets commercialized then Protalix will definitely attain record-high revenue. Thus, investing in PLX stock surged is becoming feasible.

BALANCE Phase-3 Clinical Trial Results of Protalix

On 4th April 2022, PLX published topline results from its BALANCE clinical trial. This main Phase-3 clinical trial helps in evaluating the safety and efficacy of pegunigalsidase alfa in comparison to agalsidase beta to treat Fabry disease. PRX–102 is an underdeveloped PEGylated enzyme replacement therapy for Fabry patients.

PLX Fiscal 2021/ Last Year Financial Results

(PLX) Stock surge by 46 %

Earlier on 31st March 2022, PLX happily announced its financial results for the fiscal year ended 31st December 2021. Protalix was also successful in delivering corporate updates over the current clinical developments. Cash and cash equivalents were near about US$39.0M on 31st December 2021. The company reported a net loss of US$27.6M, or per share of US$0.62, for fiscal 2021. Net loss totaled US$6.5M, or per share of US$0.22, last year.

As first announced in October 2021, as part of a Type A End–of–Review meeting, the U.S. Food and Drug Administration (FDA), in principle, agreed that the proposed analysis of the BALANCE study demonstrating non-inferiority to agalsidase beta included in the data package for the PRX–102 biologics license application (BLA) resubmission has the potential to support the approval of PRX–102 for the treatment of Fabry disease. Given the changed regulatory landscape in the United States with the full approval of agalsidase beta in March 2021, the primary analysis of the BALANCE study was changed from superiority to non-inferiority, as demonstrating superiority is no longer required under FDA guidelines. The primary endpoint of the BALANCE study compared the eGFR annualized changes (slope) between the two treatment arms in the ITT analysis set (77 patients). The study met its pre-specified primary endpoint and demonstrated that PRX-102 was statistically non-inferior to agalsidase beta.

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