Protalix resubmits BLA for PRX-102 for Fabry disease; Q3 revenue up 96% YoY

Protalix BioTherapeutics, Inc.

BLA resubmitted to FDA on Nov 9, 2022; FDA review expected within six months; milestone payment due upon approval.
Q3 2022 revenue from selling goods $8.8M up 96% YoY; net loss $3.6M ($0.07/share) vs loss $4.2M ($0.09).
Cash and equivalents $20.8M as of Sep 30, 2022.
BLA includes data from over 140 patients, phase III BALANCE, BRIDGE, BRIGHT studies, and phase I/II extension.
Chiesi Global Rare Diseases is commercialization partner; EMA also reviewing MAA for PRX-102.

item 2.02 item 8.01 item 9.01

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Protalix BioTherapeutics, Inc. reported financial results for the third quarter ended September 30, 2022.

Period: the third quarter ended September 30, 2022
Result: reported results

Exact text from the filing

On November 14, 2022, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022 and provided a business update on recent corporate and regulatory developments.

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Source: SEC EDGAR

accession 0001558370-22-017549

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