CHMP Endorses New Treatment Regimen for Fabry Disease
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 30 2026
0mins
Should l Buy PLX?
Source: Globenewswire
- Positive Opinion Issued: The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa after re-examination, with a decision from the European Commission expected by March 2026, which will provide more flexible treatment options for Fabry disease patients.
- Reducing Treatment Burden: If approved, this regimen will significantly alleviate the treatment burden on patients and their families by eliminating the need for bi-weekly visits to infusion centers or home infusions, thereby enhancing patients' quality of life and treatment adherence.
- Clinical Trial Support: The CHMP's positive opinion is informed by results from the BRIGHT study, which assessed the safety and efficacy of pegunigalsidase alfa, indicating that extending infusion intervals allows therapy to better fit into patients' daily lives, supporting work and family commitments.
- Strategic Collaboration Outlook: The partnership between Protalix BioTherapeutics and Chiesi will enable Protalix to receive a $25 million regulatory milestone payment upon approval of the E4W regimen, further advancing its innovation and market expansion in the rare disease sector.
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Analyst Views on PLX
Wall Street analysts forecast PLX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PLX is 12.00 USD with a low forecast of 12.00 USD and a high forecast of 12.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.910
Low
12.00
Averages
12.00
High
12.00
Current: 2.910
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's New Dosing Regimen Recommended for Approval
- New Dosing Regimen Recommendation: The European Medicines Agency committee has recommended approval of Protalix's new dosing regimen for pegunigalsidase alfa (Elfabrio), allowing adult patients to receive treatment every four weeks at a dose of 2mg/kg, significantly reducing patient visits and enhancing treatment convenience.
- Regulatory Milestone Payment: Protalix will be eligible for a $25 million regulatory milestone payment from Chiesi Global Rare Diseases if the new dosing regimen is approved, providing crucial financial support and reducing the risk of future capital raises for the company.
- Positive Market Reaction: Following the announcement, Protalix's stock surged 13%, reflecting investor optimism regarding the new dosing regimen, while sentiment on Stocktwits shifted from 'bullish' to 'extremely bullish', indicating a significant increase in market confidence.
- Future Decision Timeline: The European Medicines Agency is expected to announce a final decision by March 2026, and approval would offer Fabry disease patients a more flexible treatment option, further solidifying Protalix's market position in the rare disease sector.
See More
EMA Endorses New Dosing Regimen for Elfabrio
- New Dosing Regimen Approved: The European Medicines Agency (EMA) expert panel endorsed a new dosing regimen for Elfabrio, recommending a 2 mg/kg every-four-weeks schedule aimed at reducing the treatment burden for patients with Fabry disease.
- Positive Stock Reaction: Following the EMA's favorable opinion, shares of Protalix BioTherapeutics (PLX) surged approximately 14%, reflecting market optimism regarding the new regimen.
- Increased Patient Convenience: The new regimen will reduce infusion frequency for Fabry disease patients from biweekly to once every four weeks, significantly enhancing patient quality of life and treatment adherence.
- Potential Milestone Payment: If the European Commission ultimately approves the regimen, Protalix could receive a regulatory milestone payment of $25 million, further strengthening the company's financial position and market competitiveness.
See More
CHMP Endorses New Treatment Regimen for Fabry Disease
- Positive Opinion Issued: The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa after re-examination, with a decision from the European Commission expected by March 2026, which will provide more flexible treatment options for Fabry disease patients.
- Reducing Treatment Burden: If approved, this regimen will significantly alleviate the treatment burden on patients and their families by eliminating the need for bi-weekly visits to infusion centers or home infusions, thereby enhancing patients' quality of life and treatment adherence.
- Clinical Trial Support: The CHMP's positive opinion is informed by results from the BRIGHT study, which assessed the safety and efficacy of pegunigalsidase alfa, indicating that extending infusion intervals allows therapy to better fit into patients' daily lives, supporting work and family commitments.
- Strategic Collaboration Outlook: The partnership between Protalix BioTherapeutics and Chiesi will enable Protalix to receive a $25 million regulatory milestone payment upon approval of the E4W regimen, further advancing its innovation and market expansion in the rare disease sector.
See More
Elfabrio's New Dosing Regimen Receives Positive Opinion from CHMP
- Dosing Innovation: The CHMP has issued a positive opinion for Elfabrio's (pegunigalsidase alfa) 2mg/kg every-four-weeks dosing regimen, which, if approved by the European Commission, will significantly alleviate the treatment burden on patients and their families, enhancing their quality of life.
- Clinical Research Backing: This positive opinion is based on results from the BRIGHT study, which assessed the safety and efficacy of the new dosing regimen, indicating that extended infusion intervals can better meet the needs of Fabry disease patients while reducing disruptions to their daily lives.
- Significant Market Potential: If the dosing regimen is approved, Protalix will be eligible for a $25 million regulatory milestone payment from Chiesi, further strengthening its market position in rare disease treatments and driving future growth for the company.
- Patient-Centric Approach: Chiesi executives emphasized that the new dosing regimen not only focuses on effective disease management but also prioritizes patient quality of life, aiming to adapt treatment frequency to fit patients' daily lives, thereby improving treatment adherence and satisfaction.
See More
Elfabrio's New Dosing Regimen Receives Positive Opinion from CHMP
- New Dosing Regimen Recommendation: The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Elfabrio (pegunigalsidase alfa) recommending a 2mg/kg every-four-weeks dosing regimen, which is expected to be reviewed by the European Commission in March 2026, potentially alleviating treatment burdens for patients and their families.
- Clinical Trial Support: This positive opinion is based on results from the BRIGHT study, which assessed the safety and efficacy of the new dosing regimen over 52 weeks, demonstrating good tolerability and efficacy, thereby enhancing Elfabrio's competitive position in the Fabry disease treatment market.
- Significant Market Potential: If approved, Protalix will receive a $25 million regulatory milestone payment from Chiesi, which not only boosts the company's financial performance but also promotes broader adoption of Elfabrio among Fabry disease patients.
- Patient-Centric Approach: Chiesi executives emphasized that extending infusion intervals will better align treatment with patients' daily lives, reducing disruptions and reflecting the company's commitment to patient preferences, further solidifying its leadership in the rare disease sector.
See More
Pluxee Reports Q1 2026 Revenues Up 9% to €308 Million
- Revenue Growth: Pluxee achieved revenues of €308 million in Q1 Fiscal 2026, reflecting a 9% year-over-year increase, driven by strong performance in Employee Benefits, particularly through sustained new client acquisition and healthy retention rates.
- Operating Revenue Increase: Operating revenue reached €268 million, up 9.1% year-over-year, with Employee Benefits showing an impressive organic growth of 11.6%, underscoring the company's leadership position in this sector.
- M&A Strategy Execution: Pluxee successfully completed the acquisitions of Skipr and ProEves, which will enrich its diversified benefits product offerings and strengthen its market position in Belgium, France, and India, expected to drive long-term growth.
- Financial Objectives Confirmation: The company confirmed all its financial objectives for Fiscal 2026, anticipating stable total revenues and slight organic expansion in EBITDA margin, demonstrating confidence in navigating future market conditions.
See More
Protalix's New Dosing Regimen Recommended for Approval
- New Dosing Regimen Recommendation: The European Medicines Agency committee has recommended approval of Protalix's new dosing regimen for pegunigalsidase alfa (Elfabrio), allowing adult patients to receive treatment every four weeks at a dose of 2mg/kg, significantly reducing patient visits and enhancing treatment convenience.
- Regulatory Milestone Payment: Protalix will be eligible for a $25 million regulatory milestone payment from Chiesi Global Rare Diseases if the new dosing regimen is approved, providing crucial financial support and reducing the risk of future capital raises for the company.
- Positive Market Reaction: Following the announcement, Protalix's stock surged 13%, reflecting investor optimism regarding the new dosing regimen, while sentiment on Stocktwits shifted from 'bullish' to 'extremely bullish', indicating a significant increase in market confidence.
- Future Decision Timeline: The European Medicines Agency is expected to announce a final decision by March 2026, and approval would offer Fabry disease patients a more flexible treatment option, further solidifying Protalix's market position in the rare disease sector.
See More
EMA Endorses New Dosing Regimen for Elfabrio
- New Dosing Regimen Approved: The European Medicines Agency (EMA) expert panel endorsed a new dosing regimen for Elfabrio, recommending a 2 mg/kg every-four-weeks schedule aimed at reducing the treatment burden for patients with Fabry disease.
- Positive Stock Reaction: Following the EMA's favorable opinion, shares of Protalix BioTherapeutics (PLX) surged approximately 14%, reflecting market optimism regarding the new regimen.
- Increased Patient Convenience: The new regimen will reduce infusion frequency for Fabry disease patients from biweekly to once every four weeks, significantly enhancing patient quality of life and treatment adherence.
- Potential Milestone Payment: If the European Commission ultimately approves the regimen, Protalix could receive a regulatory milestone payment of $25 million, further strengthening the company's financial position and market competitiveness.
See More
CHMP Endorses New Treatment Regimen for Fabry Disease
- Positive Opinion Issued: The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa after re-examination, with a decision from the European Commission expected by March 2026, which will provide more flexible treatment options for Fabry disease patients.
- Reducing Treatment Burden: If approved, this regimen will significantly alleviate the treatment burden on patients and their families by eliminating the need for bi-weekly visits to infusion centers or home infusions, thereby enhancing patients' quality of life and treatment adherence.
- Clinical Trial Support: The CHMP's positive opinion is informed by results from the BRIGHT study, which assessed the safety and efficacy of pegunigalsidase alfa, indicating that extending infusion intervals allows therapy to better fit into patients' daily lives, supporting work and family commitments.
- Strategic Collaboration Outlook: The partnership between Protalix BioTherapeutics and Chiesi will enable Protalix to receive a $25 million regulatory milestone payment upon approval of the E4W regimen, further advancing its innovation and market expansion in the rare disease sector.
See More
Elfabrio's New Dosing Regimen Receives Positive Opinion from CHMP
- Dosing Innovation: The CHMP has issued a positive opinion for Elfabrio's (pegunigalsidase alfa) 2mg/kg every-four-weeks dosing regimen, which, if approved by the European Commission, will significantly alleviate the treatment burden on patients and their families, enhancing their quality of life.
- Clinical Research Backing: This positive opinion is based on results from the BRIGHT study, which assessed the safety and efficacy of the new dosing regimen, indicating that extended infusion intervals can better meet the needs of Fabry disease patients while reducing disruptions to their daily lives.
- Significant Market Potential: If the dosing regimen is approved, Protalix will be eligible for a $25 million regulatory milestone payment from Chiesi, further strengthening its market position in rare disease treatments and driving future growth for the company.
- Patient-Centric Approach: Chiesi executives emphasized that the new dosing regimen not only focuses on effective disease management but also prioritizes patient quality of life, aiming to adapt treatment frequency to fit patients' daily lives, thereby improving treatment adherence and satisfaction.
See More
Elfabrio's New Dosing Regimen Receives Positive Opinion from CHMP
- New Dosing Regimen Recommendation: The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Elfabrio (pegunigalsidase alfa) recommending a 2mg/kg every-four-weeks dosing regimen, which is expected to be reviewed by the European Commission in March 2026, potentially alleviating treatment burdens for patients and their families.
- Clinical Trial Support: This positive opinion is based on results from the BRIGHT study, which assessed the safety and efficacy of the new dosing regimen over 52 weeks, demonstrating good tolerability and efficacy, thereby enhancing Elfabrio's competitive position in the Fabry disease treatment market.
- Significant Market Potential: If approved, Protalix will receive a $25 million regulatory milestone payment from Chiesi, which not only boosts the company's financial performance but also promotes broader adoption of Elfabrio among Fabry disease patients.
- Patient-Centric Approach: Chiesi executives emphasized that extending infusion intervals will better align treatment with patients' daily lives, reducing disruptions and reflecting the company's commitment to patient preferences, further solidifying its leadership in the rare disease sector.
See More
Pluxee Reports Q1 2026 Revenues Up 9% to €308 Million
- Revenue Growth: Pluxee achieved revenues of €308 million in Q1 Fiscal 2026, reflecting a 9% year-over-year increase, driven by strong performance in Employee Benefits, particularly through sustained new client acquisition and healthy retention rates.
- Operating Revenue Increase: Operating revenue reached €268 million, up 9.1% year-over-year, with Employee Benefits showing an impressive organic growth of 11.6%, underscoring the company's leadership position in this sector.
- M&A Strategy Execution: Pluxee successfully completed the acquisitions of Skipr and ProEves, which will enrich its diversified benefits product offerings and strengthen its market position in Belgium, France, and India, expected to drive long-term growth.
- Financial Objectives Confirmation: The company confirmed all its financial objectives for Fiscal 2026, anticipating stable total revenues and slight organic expansion in EBITDA margin, demonstrating confidence in navigating future market conditions.
See More
