Protalix BioTherapeutics, Inc. PLX announced completion of enrollment in a phase III study, evaluating its pipeline candidate — PRX-102 (pegunigalsidase alfa) — for the treatment of Fabry disease, a rare inherited genetic lysosomal disorder.
The phase III BRIGHT study, evaluated the safety, efficacy and pharmacokinetics (PK) of PRX-102 through intravenous (IV) infusions of 2 mg/kg, administered once every four weeks to patients, previously treated with an enzyme replacement therapy (ERT) — Fabrazyme or Replagal for 12 months. Moreover, the study compared PRX-102 with the current standard of care treatment regimen of infusions every two weeks.
Fabrazyme, currently marketed by Sanofi SNY, is already approved for treating Fabry disease. Replagal too won the nod for addressing the same.
To date, all patients who enrolled in the BRIGHT program, decided to continue treatment under the 4-week dosing regimen in a long-term extension study.
Shares of Protalix have surged 35.8% so far this year, outperforming the industry’s increase of 1.4%.
Notably, last January, the FDA granted a Fast Track designation to PRX-102 for the treatment of Fabry disease. In early 2019, Protalix had a productive meeting with the FDA to discuss the potential filing of its application for the accelerated approval of PRX-102. Last month, the company announced that it plans to hold a follow-up meeting in the second quarter of 2019 to discuss the data and content of the potential filing for an expedited nod.
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 its phase II study of OPRX-106 for the treatment of ulcerative colitis.
Zacks Rank & Key Pick
Protalix currently has a Zacks Rank #4 (Sell).
A better-ranked stock in the healthcare sector is Acorda Therapeutics, Inc. ACOR, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
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