U.S. Markets open in 3 hrs 33 mins

Protalix Completes Enrollment in Third Fabry Disease Study

Zacks Equity Research

Protalix BioTherapeutics, Inc. PLX 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, 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 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.

Protalix BioTherapeutics, Inc. Price

Protalix BioTherapeutics, Inc. Price

Protalix BioTherapeutics, Inc. price | Protalix BioTherapeutics, Inc. Quote

 

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, 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%.    

5 Stocks Set to Double

Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

Today, See These 5 Potential Home Runs >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Sanofi (SNY) : Free Stock Analysis Report
 
Protalix BioTherapeutics, Inc. (PLX) : Free Stock Analysis Report
 
Acorda Therapeutics, Inc. (ACOR) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research