secwatch.observer — SEC 8-K summary
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Issuer:     Protalix BioTherapeutics, Inc. (PLX)
CIK:        0001006281
Form:       8-K
Filed at:   2026-03-09T23:59:59+00:00
Accession:  0001104659-26-024975
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

EC approves Elfabrio every-4-weeks dosing; Protalix gets $25M milestone
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- European Commission approved 2 mg/kg every-4-weeks regimen for Elfabrio in stable adult Fabry patients.
- Decision follows positive CHMP opinion; dosing reduces infusion frequency from every-2-weeks.
- Protalix entitled to a $25 million regulatory milestone payment from Chiesi upon EC approval.
- US FDA-approved dosing remains 1 mg/kg every 2 weeks; not affected by EU decision.
- BRIGHT study (PB-102-F50) and extension study supported the alternative dosing regimen.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1006281/000110465926024975/0001104659-26-024975-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1006281/000110465926024975/plx-20260309x8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-024975

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