Earnings summaries and quarterly performance for Protalix BioTherapeutics.
Executive leadership at Protalix BioTherapeutics.
Board of directors at Protalix BioTherapeutics.
Research analysts who have asked questions during Protalix BioTherapeutics earnings calls.
Recent press releases and 8-K filings for PLX.
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Positive CHMP Opinion for Elfabrio Dosing Regimen
PLX
Product Launch
New Projects/Investments
- The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of a 2 mg/kg every-four-weeks (E4W) dosing regimen for Elfabrio® (pegunigalsidase alfa) in adult Fabry disease patients in the EU.
- If approved by the European Commission (EC) by March 2026, this new regimen aims to reduce treatment burden for eligible patients by extending infusion intervals.
- Protalix BioTherapeutics is eligible to receive a $25 million regulatory milestone payment from Chiesi upon EC approval of the E4W dosing regimen.
- The E4W dosing regimen for Elfabrio is not approved in the U.S., where the approved regimen remains 1 mg/kg every 2 weeks.
7 days ago
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Positive CHMP Opinion for Elfabrio® Dosing Regimen
PLX
Product Launch
New Projects/Investments
- The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of a 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa (Elfabrio®) in adult Fabry disease patients.
- This extended dosing regimen is expected to reduce treatment burden for eligible patients, their families, and the healthcare system, as the current treatment requires infusions every two weeks.
- A decision from the European Commission (EC) on this approval is anticipated by March 2026.
- Protalix BioTherapeutics is eligible to receive a $25 million regulatory milestone payment from Chiesi if the E4W dosing regimen is approved by the EC.
7 days ago
Protalix BioTherapeutics receives positive CHMP opinion for new Fabry disease dosing regimen
PLX
Product Launch
Revenue Acceleration/Inflection
- Chiesi Global Rare Diseases and Protalix BioTherapeutics received a positive opinion from the Committee for Medicinal Product for Human Use (CHMP) for a 2mg/kg every-4-weeks (E4W) dosing regimen of pegunigalsidase alfa for adult Fabry disease patients.
- This positive opinion will be reviewed by the European Commission (EC), with a decision anticipated by March 2026.
- If approved, this new dosing regimen aims to reduce the treatment burden for eligible adult patients by extending infusion intervals.
- Protalix is eligible to receive a $25 million regulatory milestone payment from Chiesi if the E4W dosing regimen is approved by the EC.
7 days ago
Protalix BioTherapeutics Provides Business and Pipeline Update
PLX
New Projects/Investments
Guidance Update
- Protalix BioTherapeutics, Inc. issued a letter to stockholders on January 5, 2026, detailing its strategic focus on building a profitable business and an innovative pipeline for rare diseases.
- The company reported consistent commercial performance of Elfabrio® for Fabry disease with its partner Chiesi Global Rare Diseases, projecting it to capture 15% to 20% of the global Fabry market, which is expected to reach approximately $3.4 billion by 2030. An appeal outcome for the re-examination of Elfabrio's proposed 2 mg/kg every-four-weeks (E4W) dosing regimen by the European Medicines Agency is anticipated in Q1 2026, which does not affect the existing bi-weekly label.
- Protalix is advancing PRX-115 for uncontrolled gout, with positive Phase 1 clinical data demonstrating a rapid and durable urate-lowering effect and good tolerability; the Investigational New Drug (IND) application for its Phase 2 trial became effective in October 2025, and clinical sites are now activated.
- The company is also expanding its portfolio with a focus on rare kidney diseases, including PRX-119 and a new RNA-based collaboration with Secarna Pharmaceuticals.
Jan 5, 2026, 11:56 AM
Protalix BioTherapeutics Reports Q3 2025 Financial and Business Results
PLX
Earnings
New Projects/Investments
Guidance Update
- Protalix BioTherapeutics, Inc. reported net income of $2.4 million, or $0.03 per share, for the third quarter ended September 30, 2025.
- Total revenues for the third quarter of 2025 were $17.9 million, reflecting a 1% decrease compared to the same period in 2024. However, total revenues for the first nine months of 2025 increased by 24% to $43.6 million.
- Research and development expenses for Q3 2025 increased by 50% to $4.5 million, primarily due to preparations for the planned Phase 2 clinical trial of PRX-115 for uncontrolled gout.
- As of September 30, 2025, the company held $29.4 million in cash and cash equivalents and short-term bank deposits, which are expected to be sufficient for its capital needs for at least 12 months.
- A re-examination was requested in November 2025 regarding the negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on the proposed 2 mg/kg dosing regimen for Elfabrio.
Nov 13, 2025, 11:54 AM
Protalix BioTherapeutics Seeks EMA Re-examination for Elfabrio Dosing Regimen
PLX
New Projects/Investments
- Protalix BioTherapeutics, Inc. and its partner Chiesi Global Rare Diseases have requested a re-examination from the European Medicines Agency (EMA) regarding a negative opinion for an alternative dosing regimen of Elfabrio® (pegunigalsidase alfa).
- The negative opinion specifically concerns the proposed 2 mg/kg body weight infused every four weeks (E4W) dosing regimen for Elfabrio.
- The existing marketing authorization for Elfabrio's 1 mg/kg every two weeks (E2W) dosing regimen in the EU remains in effect.
- Elfabrio is indicated for the treatment of adults with confirmed Fabry disease and received approval from both the FDA and EMA in May 2023.
Nov 3, 2025, 9:44 PM
Protalix BioTherapeutics receives negative EU opinion for Elfabrio dosing regimen
PLX
New Projects/Investments
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the request to approve the every four-week dosing regimen for Elfabrio (pegunigalsidase alfa) in the EU; the every two-week dosing regimen remains approved.
- Protalix reported $53 million in revenue for FY 2024 and had $33.4 million in cash as of June 30, 2025, with a projected cash runway into 2027.
- The company expects to start a Phase 2 study for PRX-115, a treatment for uncontrolled gout, in Q4 2025.
Oct 17, 2025, 12:08 PM
Protalix BioTherapeutics Provides Business Update and Outlines Key Catalysts
PLX
Product Launch
New Projects/Investments
Guidance Update
- Protalix BioTherapeutics, leveraging its plant cell technology, has two approved drugs: Elelyso for Gaucher disease, generating $22-$24 million annually , and Elfabrio for Fabry disease, licensed to Chiesi, with anticipated $100-$120 million in net royalties by the end of the decade from a projected $3.2 billion market.
- The company's most advanced pipeline asset, PRX-115 for uncontrolled severe gout, is set to begin its Phase 2 trial in November 2025, with top-line results anticipated in late H1 or early H2 2027.
- Protalix reported approximately $34 million in cash as of the end of Q2 2025 and zero debt, confirming it is funded for day-to-day operations.
- A near-term catalyst includes the CHMP opinion on a once-a-month dosing regimen for Elfabrio, expected by mid to late October 2025.
Sep 16, 2025, 2:30 PM
Protalix BioTherapeutics Discusses Commercial Portfolio, Pipeline, and Financial Position
PLX
Product Launch
New Projects/Investments
Guidance Update
- Protalix BioTherapeutics utilizes a unique plant cell-based technology for expressing complex human proteins, offering advantages such as lower setup costs and no viral contamination risk compared to mammalian cell systems.
- The company has two approved drugs: Elelyso for Gaucher disease, generating $22-$24 million annually from Pfizer and Bio-Manguinhos, and Elfabrio for Fabry disease, licensed to Chiesi, with potential net royalties of $100-$120 million annually by the end of the decade, plus significant milestones.
- A key pipeline asset, PRX-115 for uncontrolled severe gout, is expected to begin its Phase 2 trial with the first patient in November, following promising Phase 1 results suggesting a potential once every six to eight weeks dosing regimen.
- Upcoming catalysts include the CHMP opinion on Elfabrio's once-a-month dosing regimen, expected by mid to late October, and the initiation of the PRX-115 Phase 2 trial.
- Protalix is well-capitalized with approximately $34 million in cash as of the end of Q2 and zero debt, funding its day-to-day operations.
Sep 16, 2025, 2:30 PM
Protalix BioTherapeutics Highlights Commercial Portfolio and Pipeline at Investor Summit
PLX
New Projects/Investments
Guidance Update
CFO Change
- Protalix BioTherapeutics, leveraging its unique plant cell technology, has two approved drugs: Elelyso for Gaucher disease (licensed to Pfizer) and Elfabrio for Fabry disease (licensed to Chiesi).
- Elfabrio is projected to generate $100 million-$120 million in net royalties for Protalix by the end of the decade, alongside potential commercial milestones.
- A significant near-term catalyst is the anticipated mid to late October decision from the EMA regarding approval of a once-a-month dosing regimen for Elfabrio.
- The company's pipeline includes PRX-115 for uncontrolled severe gout, with a Phase II trial commencing in November and top-line results expected in H2 2027 or late H1 2027.
- Protalix is well-capitalized with approximately $34 million as of the end of Q2, zero debt, and is funded for its ongoing operations.
Sep 16, 2025, 2:30 PM
Quarterly earnings call transcripts for Protalix BioTherapeutics.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more