secwatch.observer — SEC 8-K summary
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Issuer:     Protalix BioTherapeutics, Inc. (PLX)
CIK:        0001006281
Form:       8-K
Filed at:   2022-11-14T23:59:59+00:00
Accession:  0001558370-22-017549
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/0001558370-22-017549-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/plx-20221109x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-22-017549

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer