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Protalix BioTherapeutics Reports First Quarter 2026 Financial Results and Reaffirms Guidance
Received $25 million milestone from Chiesi following European Commission approval of Elfabrio 2 mg/kg every-4-weeks dosing regimen.
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Protalix reports FY2025 results; EC approves Elfabrio E4W regimen triggering $25M milestone
EC approved Elfabrio 2mg/kg every-4-weeks dosing for stable adults with Fabry in EU; $25M milestone from Chiesi triggered.
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EC approves Elfabrio every-4-weeks dosing; Protalix gets $25M milestone
European Commission approved 2 mg/kg every-4-weeks regimen for Elfabrio in stable adult Fabry patients.
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Protalix gets positive CHMP opinion for every-4-week dosing of Elfabrio in EU; $25M milestone if EC approves
CHMP issued positive opinion for 2 mg/kg every-4-weeks dosing regimen of Elfabrio for stable Fabry adults.
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Protalix provides business update; PRX-115 Phase 2 IND effective, gout market focus
PRX-115 Phase 1 data show rapid, durable urate lowering lasting 12 weeks at higher doses; Phase 2 IND effective.
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Protalix and Chiesi request re-examination of negative EMA opinion on Elfabrio E4W dosing regimen
CHMP issued negative opinion on Elfabrio 2 mg/kg every-4-weeks dosing regimen; re-examination requested.
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Protalix and Chiesi receive CHMP negative opinion on every-4-week dosing for Elfabrio in EU
CHMP issued negative opinion for 2 mg/kg every 4 weeks dosing of Elfabrio (pegunigalsidase alfa) for Fabry disease.
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Protalix Q2 2025: Revenue $15.4M (+16% YoY), net income $164K; CFO transition, PRX-115 trial on track
Revenue from goods $15.4M (+16% YoY); net income $164K vs $2.2M loss, EPS $0.00.
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Protalix BioTherapeutics Q1 revenue up 170% to $10.0M, net loss narrows to $3.6M
Revenues from selling goods $10.0M, up 170% YoY, driven by $5.9M increase in sales to Pfizer.
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Protalix FY 2024: Record product revenue $53M (+31%), net income $2.9M; debt-free
Revenue from goods $53.0M (+31% YoY), driven by Chiesi sales (+$11.8M); total revenue $53.4M vs $65.5M in 2023.
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Protalix increases ATM equity offering capacity by $20M for general corporate purposes
Amendment with H.C. Wainwright increases ATM offering capacity by $20M in aggregate gross sales price.
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Protalix repays all convertible notes, becomes debt-free; EMA validates Fabry drug dosing variation
Repaid in full all outstanding convertible notes, making company debt-free.
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Protalix Q3 net income $3.2M, revenue up 75%; PRX-115 Phase I positive
Revenue from goods $17.8M (+75% YoY); net income $3.2M vs loss $1.9M in Q3 2023; EPS $0.04 basic.
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Protalix Q2 2024: revenue $13.5M, net loss $2.2M; PRX-115 Phase I topline expected Q3
Total Q2 2024 revenue $13.5M vs $35.1M in Q2 2023; net loss $2.2M ($0.03/sh) vs net income $19.3M ($0.29/sh).
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Protalix Q1 net loss $4.6M; PRX-115 phase I positive, adds cohort
Revenue from goods $3.7M (-27% YoY); license/R&D services $0.1M (-98%) as Elfabrio obligations completed.
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Protalix reports 2023 net income $8.3M vs loss; Elfabrio approvals, $20M milestone
Revenue from goods $40.4M (+60% YoY); license/R&D services $25.1M (+13%).
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Protalix updates on Elfabrio approvals, PRX-115 Phase I progress, and pipeline
Elfabrio (Fabry disease) approved by FDA and EMA; launched in US, EU, UK via Chiesi partnership.
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Protalix Q3 revenues from goods up 16% to $10.2M; net loss narrows to $1.9M
Revenues from selling goods $10.2M (+16% YoY), driven by Elfabrio sales to Chiesi after FDA/EMA approvals.
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Protalix reports Q2 net income of $19.3M on Elfabrio sales and $20M milestone
Revenue from goods $15.1M (+344% YoY) driven by Elfabrio sales to Chiesi after FDA/EMA approvals.
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Protalix announces FDA and EU approval of Elfabrio for Fabry disease; investor event June 27
Elfabrio (pegunigalsidase alfa) approved in both US and EU for adult Fabry disease patients.
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Protalix receives $20M milestone from Chiesi after FDA approval of ELFABRIO
$20M milestone triggered by FDA approval of ELFABRIO (pegunigalsidase alfa-iwxj) for Fabry disease; payable within 30 days.
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FDA approves Protalix/Chiesi's ELFABRIO for Fabry disease in adults
FDA approved ELFABRIO (pegunigalsidase alfa-iwxj) for adult Fabry disease patients.
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European Commission approves Protalix's PRX-102 for Fabry disease in EU
EC granted marketing authorization to PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.
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Protalix Q1 net loss $3.1M on revenue decline; positive CHMP opinion for PRX-102
Revenue from goods fell 43% to $5.1M; license and R&D revenue down 37% to $4.5M.
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Protalix FY2022 net loss narrows to $14.9M; CHMP positive opinion for PRX-102; FDA PDUFA May 9
Net loss of $14.9M ($0.31/share) vs $27.6M ($0.62/share) in FY2021; revenue from goods up 51% to $25.3M.
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Protalix BioTherapeutics enters $20M at-the-market equity offering with H.C. Wainwright
ATM offering of up to $20M of common stock via H.C. Wainwright & Co. as sales agent.
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Protalix and Chiesi receive positive CHMP opinion for PRX-102 (pegunigalsidase alfa) for Fabry disease
CHMP adopted positive opinion recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.
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Protalix updates on PRX-102 FDA PDUFA date May 9, 2023; PRX-115 Phase I in Q1 2023
MAA submitted to EMA Feb 2022; BLA resubmitted to FDA Nov 2022 with PDUFA goal date May 9, 2023.
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Protalix resubmits BLA for PRX-102 for Fabry disease; Q3 revenue up 96% YoY
BLA resubmitted to FDA on Nov 9, 2022; FDA review expected within six months; milestone payment due upon approval.
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Protalix Q2 net loss narrows to $5.3M; PRX-102 Phase III CSR complete
Total revenues $8.8M ($3.4M product sales +$5.4M license/R&D), up 38% YoY.
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Protalix appoints Shmuel Ben Zvi to board; stockholders approve share increase to 144M
Dr. Shmuel Ben Zvi appointed as independent director, joining Audit and Compensation Committees.