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Protalix Completes Enrollment in Third Fabry Disease Study

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Protalix BioTherapeutics, Inc. (PLX - Free Report) announced that it has completed enrollment in the third phase III study, evaluating its pipeline candidate — PRX-102 (pegunigalsidase alfa) — for the treatment of Fabry disease, a rare inherited genetic lysosomal disorder.

The BALANCE study is designed to evaluate the safety and efficacy of PRX-102 compared to Fabrazyme (agalsidase beta) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta.

Fabrazyme, currently marketed by Sanofi (SNY - Free Report) , is already approved for treating Fabry disease. Replagal too won the nod for addressing the same.

Shares of Protalix have slumped 33.5% so far this year compared with the industry’s decline of 3.2%.


BALANCE is the third phase III study on PRX-102. The first two studies — BRIDGE and BRIGHT — are both fully enrolled and ongoing.

Along with the press release, the company said it plans to submit a biologics license application (BLA) to the FDA under an accelerated approval pathway for PRX-102 in the first quarter of 2020. The BLA will be supported by results from the completed phase I/II studies of PRX-102 and the ongoing phase III BRIDGE clinical study.

Notably, in January 2018, the FDA granted a Fast Track designation to the candidate for the treatment of Fabry disease.

We would like to remind investors that Protalix has a single marketed drug, Elelyso, approved for treating Gaucher disease. The drug is marketed by Pfizer Inc. (PFE - Free Report) in the United States as part of an exclusive license and supply agreement.

The company is also developing OPRX-106 as an orally-delivered anti-inflammatory treatment. In 2018, it delivered positive results from the phase II OPRX-106 study for the treatment of ulcerative colitis.


Zacks Rank & A Stock to Consider

Currently, Protalix is a Zacks Rank #3 (Hold) stock.

A better-ranked stock in the biotech sector is Acorda Therapeutics Inc. (ACOR - Free Report) , carrying a Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates for the current year narrowed from $3.51 to $2.74 over the past 60 days. The company recorded a positive earnings surprise in the preceding four quarters, the average beat being 69.68%.    

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