Protalix BioTherapeutics, Inc. (PLX - Free Report) and its Italian partner Chiesi Farmaceutici S.p.A. announced that they have successfully completed a type B pre-Biologics License Application (“BLA”) meeting with the FDA regarding the accelerated approval pathway for their lead pipeline candidate, pegunigalsidase alfa (PRX-102). The companies are looking to get the candidate approved for treating Fabry disease, a rare inherited genetic lysosomal disorder.
Shares of Protalix surged 32.3% on Nov 18 following the announcement. However, the company’s shares have declined 17% so far this year against the industry’s growth of 2.4%.
Protalix is a small biotech, focusing on the development of recombinant therapeutic proteins developed using its proprietary ProCellEx plant cell-based protein expression system for treating rare diseases.
Per the meeting, data from the previously completed phase I/II study on pegunigalsidase alfa and the ongoing phase III BRIDGE study will be included in the BLA. The regulatory application is expected to be filed with the FDA by April 2020.
The BRIDGE study evaluated pegunigalsidase alfa in patients with Fabry disease, who received treatment with Sanofi’s (SNY - Free Report) Fabry disease medicine Replagal (agalsidase alfa) for at least two years and were on a stable dose for at least six months. Interim data from the study announced last month looked promising and the candidate was well tolerated in patients.
Moreover, in the meeting, Protalix finalized the enrollment target for its confirmatory phase III study — BALANCE — evaluating pegunigalsidase alfa in Fabry disease. Data from the study will support continued approval for the candidate, if approved under accelerated approval pathway.
The BALANCE study is designed to evaluate the safety and efficacy of pegunigalsidase alfa compared to Sanofi’s another Fabry disease drug, Fabrazyme (agalsidase beta), on renal function in Fabry patients with progressing kidney disease, who have been previously treated with Replagal.
BALANCE is the third phase III study on PRX-102. The first two studies — BRIDGE and BRIGHT — are both fully enrolled and ongoing.
Zacks Rank & Stocks to Consider
Protalix currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the pharmaceutical sector include BioDelivery Sciences International, Inc. (BDSI - Free Report) and Alkermes plc (ALKS - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), BioDelivery carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings estimates increased from 36 cents to 52 cents for 2019 and estimates changed from a loss of 11 cents to earnings of 59 cents for 2020 over the past 30 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 236.8%.
BioDelivery’s loss estimates have narrowed from 22 cents to 16 cents for 2019 and earnings estimates moved up from 27 cents to 31 cents for 2020 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 159.38%. Share price of the company has increased 64.6% so far this year.
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