Protalix Q4 2022 Earnings Report
Key Takeaways
Protalix BioTherapeutics reported financial results for the fiscal year ended December 31, 2022. The company saw an increase in revenues from selling goods, driven by higher sales to Pfizer, Brazil, and Chiesi. Revenue from licenses and R&D services also increased slightly. The company's net loss decreased compared to the previous year.
EMA's CHMP adopted a positive opinion for PRX-102 for adult patients with Fabry disease.
FDA accepted the resubmitted BLA for PRX-102 for the treatment of adult patients with Fabry disease with an action date of May 9, 2023.
BALANCE study met its primary endpoint, demonstrating PRX-102 was statistically non-inferior to agalsidase beta.
BRIGHT study results indicate that PRX-102 was well tolerated, and Fabry disease was stable throughout PRX-102 treatment in adult Fabry patients.
Protalix
Protalix
Forward Guidance
Protalix anticipates a significant year with potential regulatory approvals in Europe and the United States anticipated in May 2023 and continued advancement of its early-stage pipeline.
Positive Outlook
- Potential regulatory approvals in Europe and the United States anticipated in May 2023
- Continued advancement of our early-stage pipeline