We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Protalix Completes Enrollment in Third Fabry Disease Study
Read MoreHide Full Article
Protalix BioTherapeutics, Inc. 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.
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.
Image: Bigstock
Protalix Completes Enrollment in Third Fabry Disease Study
Protalix BioTherapeutics, Inc. 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.
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. , 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 >>