Chiesi and Protalix Update on Elfabrio Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 30 2026
0mins
Should l Buy PLX?
Chiesi Global Rare Diseases and Protalix BioTherapeutics announced an update on Elfabrio. The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks dosing regimen for Elfabrio in Fabry disease adult patients stable with an ERT treatment. This positive opinion follows the CHMP's re-examination of the company's application for the additional dosing regimen.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy PLX?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on PLX
Wall Street analysts forecast PLX stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.070
Low
12.00
Averages
12.00
High
12.00
Current: 2.070
Low
12.00
Averages
12.00
High
12.00
About PLX
Protalix BioTherapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. In addition, the Company is developing PEGylated uricase, or PRX-115, for the treatment of uncontrolled gout, Long Acting (LA) DNase I, or PRX-119, for the treatment of NETs-related diseases, and other technologies and preclinical assets. Its ProCellEx platform is being used to manufacture both of its approved and marketed products as well as PRX-115 and PRX-119. PRX-115, a plant cell-expressed recombinant PEGylated Uricase (urate oxidase) - a chemically modified enzyme to treat uncontrolled gout. PRX-119 is a plant cell-expressed PEGylated recombinant human DNase I product candidate. Its product includes Elelyso and Elfabrio. Elelyso is an enzyme replacement therapy (ERT) for the treatment of patients with Gaucher disease.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Protalix BioTherapeutics Reports FY 2025 Results with Mixed Performance
- Product Sales Performance: Protalix reported product sales of $51.8 million for FY 2025, a slight decline from $53.0 million in 2024, primarily due to reduced sales to partner Chiesi, although increased demand from Pfizer and Brazil's Fiocruz partially offset this decline.
- Financial Performance: The company reported a net loss of $6.6 million, or $(0.08) per share, compared to a net income of $2.9 million, or $0.04 per share, in 2024, indicating a significant deterioration in profitability.
- Cash Flow Position: As of year-end 2025, Protalix had cash and cash equivalents of $30.3 million, with expectations to strengthen to about $50.0 million by April 2026, supported by a $25 million milestone payment from Chiesi.
- Future Outlook: Management projects 2026 revenues between $78 million and $83 million, with Elfabrio sales expected to contribute $33.0 million to $35.0 million and Elelyso sales forecasted at $20.0 million to $23.0 million, indicating ongoing growth potential in rare disease therapies.
See More
Protalix BioTherapeutics Q4 2025 Earnings Call Insights
- EU Dosing Approval: Protalix announced the European Commission's approval of Elfabrio's 2 mg/kg every 4-week dosing regimen, enhancing treatment options for adult Fabry disease patients and expected to significantly improve long-term management, thereby strengthening the company's competitive position in the market.
- Revenue Growth Outlook: Management projects total revenues for 2026 to range from $78 million to $83 million, including a $25 million milestone payment from Chiesi, with expected revenue from Chiesi growing over 50%, which will further solidify the company's profitability profile.
- Increased R&D Investment: R&D expenses reached $19.6 million in 2025, primarily driven by investments in the PRX-115 RELEASE study, which is anticipated to enhance the company's competitive edge in the uncontrolled gout market, with management expressing optimism about the product's prospects.
- Strong Cash Position: As of December 31, 2025, Protalix's cash and cash equivalents totaled $30.3 million, with expectations to reach approximately $50 million by early 2026, providing ample financial support for executing strategies and clinical trials.
See More
Protalix BioTherapeutics Reports Disappointing Earnings
- Disappointing Earnings: Protalix BioTherapeutics reported a FY GAAP EPS of -$0.08, missing estimates by $0.07, indicating challenges in profitability for the company.
- Revenue Decline: The reported revenue of $52.74 million represents a 1.2% year-over-year decline, falling short of market expectations by $5.24 million, reflecting sluggish sales growth.
- Future Revenue Outlook: Management anticipates total revenues in 2026 to range from approximately $78 million to $83 million, including a $25 million payment, exceeding the consensus estimate of $71.81 million, demonstrating confidence in future growth.
- Clinical Trial Progress: The Phase 2 clinical trial of PRX-115 is actively enrolling, with Protalix believing that this therapy has the potential to be best-in-class, aimed at improving compliance and outcomes for patients with uncontrolled gout.
See More
Protalix BioTherapeutics Earnings Announcement Scheduled
- Earnings Release Date: Protalix BioTherapeutics is set to announce its FY earnings on March 18 before market open, with a consensus EPS estimate of -$0.01, reflecting a significant 125% year-over-year decline, indicating pressure on profitability.
- Revenue Expectations: The revenue estimate stands at $57.98 million, representing an 8.6% year-over-year increase, suggesting some growth potential despite challenges, which reflects the company's stability in the market.
- Performance Beat Record: Over the past year, Protalix has beaten EPS estimates 50% of the time and revenue estimates 100% of the time, demonstrating the company's capability in revenue management and market forecasting.
- EU New Regimen: Protalix announced that an EU panel recommended a new dosing regimen for its Fabry disease therapy, a decision that could significantly enhance the company's market outlook and product acceptance.
See More
Protalix BioTherapeutics Schedules Financial Results Conference Call
- Earnings Release Announcement: Protalix BioTherapeutics is set to release its financial results for the fiscal year ending December 31, 2025, on March 18, 2026, highlighting the company's commitment to transparency and investor communication.
- Conference Call Details: The call will take place at 8:00 a.m. EDT, with participants encouraged to join 15 minutes early to ensure smooth registration and audio software installation, reflecting the company's focus on enhancing investor experience.
- Webcast Information: The conference will be webcast live on the Protalix website, allowing participants to access the event through provided links, thereby increasing information accessibility and transparency.
- Product Development Background: Protalix focuses on developing recombinant therapeutic proteins through its proprietary ProCellEx plant cell expression system, having received FDA approval, showcasing its innovative capabilities and market potential in the biopharmaceutical sector.
See More
Elfabrio's New Dosing Regimen Approved by EU
- EU Dosing Approval: The European Commission has approved a new dosing regimen for Elfabrio (pegunigalsidase alfa) at 2mg/kg every four weeks, aimed at providing greater flexibility for stable Fabry disease patients, thereby reducing the treatment burden on patients and their families.
- Burden Reduction: This new regimen extends the infusion interval from every two weeks to every four weeks, helping patients and families minimize frequent infusion visits, which enhances quality of life and aligns with the long-term treatment needs of Fabry disease patients.
- Clinical Research Support: The approval is backed by positive results from the BRIGHT study, demonstrating the new dosing regimen's favorable safety and efficacy profile, further solidifying Elfabrio's position in the treatment landscape for Fabry disease.
- Market Impact and Collaboration: The partnership between Chiesi Global Rare Diseases and Protalix BioTherapeutics will facilitate the rollout of the new dosing regimen across the EU, expected to expand Elfabrio's market reach and enhance the company's competitiveness in the rare disease sector.
See More
Protalix BioTherapeutics Reports FY 2025 Results with Mixed Performance
- Product Sales Performance: Protalix reported product sales of $51.8 million for FY 2025, a slight decline from $53.0 million in 2024, primarily due to reduced sales to partner Chiesi, although increased demand from Pfizer and Brazil's Fiocruz partially offset this decline.
- Financial Performance: The company reported a net loss of $6.6 million, or $(0.08) per share, compared to a net income of $2.9 million, or $0.04 per share, in 2024, indicating a significant deterioration in profitability.
- Cash Flow Position: As of year-end 2025, Protalix had cash and cash equivalents of $30.3 million, with expectations to strengthen to about $50.0 million by April 2026, supported by a $25 million milestone payment from Chiesi.
- Future Outlook: Management projects 2026 revenues between $78 million and $83 million, with Elfabrio sales expected to contribute $33.0 million to $35.0 million and Elelyso sales forecasted at $20.0 million to $23.0 million, indicating ongoing growth potential in rare disease therapies.
See More
Protalix BioTherapeutics Q4 2025 Earnings Call Insights
- EU Dosing Approval: Protalix announced the European Commission's approval of Elfabrio's 2 mg/kg every 4-week dosing regimen, enhancing treatment options for adult Fabry disease patients and expected to significantly improve long-term management, thereby strengthening the company's competitive position in the market.
- Revenue Growth Outlook: Management projects total revenues for 2026 to range from $78 million to $83 million, including a $25 million milestone payment from Chiesi, with expected revenue from Chiesi growing over 50%, which will further solidify the company's profitability profile.
- Increased R&D Investment: R&D expenses reached $19.6 million in 2025, primarily driven by investments in the PRX-115 RELEASE study, which is anticipated to enhance the company's competitive edge in the uncontrolled gout market, with management expressing optimism about the product's prospects.
- Strong Cash Position: As of December 31, 2025, Protalix's cash and cash equivalents totaled $30.3 million, with expectations to reach approximately $50 million by early 2026, providing ample financial support for executing strategies and clinical trials.
See More
Protalix BioTherapeutics Reports Disappointing Earnings
- Disappointing Earnings: Protalix BioTherapeutics reported a FY GAAP EPS of -$0.08, missing estimates by $0.07, indicating challenges in profitability for the company.
- Revenue Decline: The reported revenue of $52.74 million represents a 1.2% year-over-year decline, falling short of market expectations by $5.24 million, reflecting sluggish sales growth.
- Future Revenue Outlook: Management anticipates total revenues in 2026 to range from approximately $78 million to $83 million, including a $25 million payment, exceeding the consensus estimate of $71.81 million, demonstrating confidence in future growth.
- Clinical Trial Progress: The Phase 2 clinical trial of PRX-115 is actively enrolling, with Protalix believing that this therapy has the potential to be best-in-class, aimed at improving compliance and outcomes for patients with uncontrolled gout.
See More
Protalix BioTherapeutics Earnings Announcement Scheduled
- Earnings Release Date: Protalix BioTherapeutics is set to announce its FY earnings on March 18 before market open, with a consensus EPS estimate of -$0.01, reflecting a significant 125% year-over-year decline, indicating pressure on profitability.
- Revenue Expectations: The revenue estimate stands at $57.98 million, representing an 8.6% year-over-year increase, suggesting some growth potential despite challenges, which reflects the company's stability in the market.
- Performance Beat Record: Over the past year, Protalix has beaten EPS estimates 50% of the time and revenue estimates 100% of the time, demonstrating the company's capability in revenue management and market forecasting.
- EU New Regimen: Protalix announced that an EU panel recommended a new dosing regimen for its Fabry disease therapy, a decision that could significantly enhance the company's market outlook and product acceptance.
See More
Protalix BioTherapeutics Schedules Financial Results Conference Call
- Earnings Release Announcement: Protalix BioTherapeutics is set to release its financial results for the fiscal year ending December 31, 2025, on March 18, 2026, highlighting the company's commitment to transparency and investor communication.
- Conference Call Details: The call will take place at 8:00 a.m. EDT, with participants encouraged to join 15 minutes early to ensure smooth registration and audio software installation, reflecting the company's focus on enhancing investor experience.
- Webcast Information: The conference will be webcast live on the Protalix website, allowing participants to access the event through provided links, thereby increasing information accessibility and transparency.
- Product Development Background: Protalix focuses on developing recombinant therapeutic proteins through its proprietary ProCellEx plant cell expression system, having received FDA approval, showcasing its innovative capabilities and market potential in the biopharmaceutical sector.
See More
Elfabrio's New Dosing Regimen Approved by EU
- EU Dosing Approval: The European Commission has approved a new dosing regimen for Elfabrio (pegunigalsidase alfa) at 2mg/kg every four weeks, aimed at providing greater flexibility for stable Fabry disease patients, thereby reducing the treatment burden on patients and their families.
- Burden Reduction: This new regimen extends the infusion interval from every two weeks to every four weeks, helping patients and families minimize frequent infusion visits, which enhances quality of life and aligns with the long-term treatment needs of Fabry disease patients.
- Clinical Research Support: The approval is backed by positive results from the BRIGHT study, demonstrating the new dosing regimen's favorable safety and efficacy profile, further solidifying Elfabrio's position in the treatment landscape for Fabry disease.
- Market Impact and Collaboration: The partnership between Chiesi Global Rare Diseases and Protalix BioTherapeutics will facilitate the rollout of the new dosing regimen across the EU, expected to expand Elfabrio's market reach and enhance the company's competitiveness in the rare disease sector.
See More
