Record mula sa primary source
MateryalUpdate sa FDA label
Protalix: Inaprubahan ng EC/MHRA ang dosing ng Elfabrio E4W para sa Fabry
Ang European Commission at MHRA ay inaprubahan ang bagong dosing regimen na 2 mg/kg kada-4-linggo para sa Elfabrio sa mga nasa hustong gulang na may sakit na Fabry na stable sa ERT, na ginagawa itong tanging ERT sa EU/UK na nag-aalok ng opsyon sa E4W. Natanggap ng Protalix ang $25 milyong regulatory milestone payment mula sa Chiesi. Ang dosing na inaprubahan ng FDA sa US ay nananatiling 1 mg/kg kada 2 linggo.
Mahahalagang fact
- Na-file
- May 21, 2026, 11:03 AM
- Kaganapan
- Update sa FDA label
- Direksyon
- Positibo
- Kumpanya
PLXProtalix BioTherapeutics- Asset
- pegunigalsidase alfa
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Bayad sa yugto
- $25 milyon
Sipi mula sa source
EX-99.1 2 plx-20260521xex99d1.htm EX-99.1 Exhibit 99.1 1 PROTALIX BIOTHERAPEUTICS C O R P O R A T E P R E S E N T A T I O N J u n e 2024 PROTALIX BIOTHERAPEUTICS Pioneering solutions to transform the treatment of rare diseases C O R P O R A T E P R E S E N T A T I O N M a y 2026 2 Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current expectations or plans, and projections for future operating and financial performance, based on assumptions currently