secwatch.observer — SEC 8-K summary
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Issuer:     Protalix BioTherapeutics, Inc. (PLX)
CIK:        0001006281
Form:       8-K
Filed at:   2023-02-27T23:59:59+00:00
Accession:  0001558370-23-002100
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Protalix FY2022 net loss narrows to $14.9M; CHMP positive opinion for PRX-102; FDA PDUFA May 9
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- Net loss of $14.9M ($0.31/share) vs $27.6M ($0.62/share) in FY2021; revenue from goods up 51% to $25.3M.
- EMA CHMP adopted positive opinion recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for Fabry disease; EC decision expected May 2023.
- FDA accepted resubmitted BLA for PRX-102 with PDUFA action date of May 9, 2023; milestone payment from Chiesi if approved.
- Cash and equivalents $22.2M at Dec 31, 2022; voluntary delisting from Tel Aviv Stock Exchange effective March 22, 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1006281/000155837023002100/0001558370-23-002100-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1006281/000155837023002100/plx-20230227x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-23-002100

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