Protalix and Secarna Collaborate on Rare Renal Disease Therapies
Protalix and Secarna Pharmaceuticals announced that they have entered into a collaboration and option agreement. Under this agreement, the companies have agreed to partner in the discovery of novel antisense oligonucleotide therapies against multiple targets for rare renal indications. As part of the collaboration, Protalix has selected pharmaceutical targets with fundamental biological roles in rare renal indications and Secarna will apply OligoCreator, its proprietary AI-empowered oligonucleotide discovery and development platform, to design and profile ASO candidates against those targets. By jointly applying their research and development expertise, it is the companies' goal to advance the programs from preclinical stage to clinical trials. Under the terms of the collaboration agreement, Secarna grants Protalix an option to an exclusive, worldwide milestone and royalty bearing license to further develop, market and commercialize therapeutic programs.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.









