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Protalix BioTherapeutics Letter to Stockholders
Prnewswire· 2026-01-05 11:50
Core Viewpoint - Protalix BioTherapeutics is focused on advancing its innovative pipeline for rare diseases, particularly targeting uncontrolled gout and rare kidney diseases, while maintaining a profitable commercial business through strategic partnerships [2][14]. Pipeline and Product Development - The company is advancing PRX-115 for uncontrolled gout, which has shown a rapid and durable urate-lowering effect in Phase 1 trials, indicating its potential as a differentiated treatment option [3][15]. - PRX-119 is being developed as a long-acting DNase I for treating inflammation and fibrosis in rare kidney diseases, reflecting the company's strategic focus on this area [4][13]. - The company has submitted an Investigational New Drug (IND) application for PRX-115, which has been approved by the FDA, and the first clinical sites are now activated [15]. Commercial Execution and Market Positioning - Protalix has achieved solid performance with its partner Chiesi Global Rare Diseases, particularly with the launch of Elfabrio for Fabry disease, tracking well against core indicators such as treated patient counts and market share [6][7]. - The global Fabry market is projected to reach approximately $3.4 billion by 2030, with Protalix expecting Elfabrio to capture 15% to 20% of this market [7]. - An appeal regarding a negative opinion from the European Medicines Agency on Elfabrio's dosing regimen is underway, with an outcome expected in Q1 2026 [8]. Strategic Partnerships and Collaborations - The company continues to benefit from established revenue streams, including Elelyso, through collaborations with Pfizer and Fundação Oswaldo Cruz, which support its operational resilience [9]. - A recent collaboration with Secarna Pharmaceuticals aims to develop novel therapeutic candidates for rare renal indications using AI technology [15]. Long-Term Growth and Value Creation - Protalix enters 2026 with a profitable commercial foundation and a focused pipeline addressing high unmet medical needs, aiming to create long-term value for patients and shareholders [14]. - The company emphasizes its commitment to delivering meaningful therapies while pursuing strategic partnerships to enhance its impact and scale [5][14].
Protalix Biotherapeutics and Secarna Pharmaceuticals Enter into Collaboration and Option Agreement
Prnewswire· 2025-12-17 11:50
Core Insights - Protalix BioTherapeutics and Secarna Pharmaceuticals have entered into a collaboration and option agreement to develop antisense oligonucleotide therapies for rare renal diseases, leveraging Protalix's expertise in rare diseases and Secarna's AI-powered OligoCreator platform [1][2][3] Company Overview - Protalix BioTherapeutics focuses on innovative therapeutics for rare diseases and has developed two enzyme replacement therapies available in multiple markets, utilizing a proprietary plant cell-based expression system called ProCellEx [4][5] - Secarna Pharmaceuticals specializes in oligonucleotide therapeutics and employs its OligoCreator platform to rapidly generate high-quality antisense candidates, aiming to transform untreatable conditions into treatable ones [7] Collaboration Details - The collaboration involves Protalix selecting pharmaceutical targets for rare renal indications, while Secarna will use its OligoCreator platform to design and profile ASO candidates against these targets [2] - Protalix has the option for an exclusive, worldwide license to further develop and commercialize the therapeutic programs resulting from this collaboration [2][3] Strategic Goals - The partnership aims to advance programs from preclinical stages to clinical trials, addressing significant unmet medical needs in the rare kidney disease space [2][3] - Both companies express excitement about the collaboration, highlighting the combination of Secarna's rapid candidate generation and Protalix's experience in bringing therapies to market [3]
Protalix and Chiesi seek EMA re-examination of Elfabrio dosing opinion
Proactiveinvestors NA· 2025-11-04 14:00
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
Protalix BioTherapeutics, Inc. (PLX) Gains Investor Confidence With Major Stake Increase
Yahoo Finance· 2025-09-29 22:50
Company Overview - Protalix BioTherapeutics, Inc. is a New Jersey-based biopharmaceutical company specializing in recombinant therapeutic proteins [4] - The company develops innovative plant-based biologics, including products like Elelyso, Elfabrio, PRX-115, and PRX-119 [4] Investment Activity - Goldman Sachs Group Inc. increased its holdings in Protalix BioTherapeutics by 482.3% during the first quarter, acquiring 239,751 shares, bringing its total ownership to 289,461 shares valued at approximately $741,000 [1] Product Development - Protalix is expanding its ProCellEx platform into drug delivery optimization, targeting specific tissue requirements, which is considered a "game-changer" for the company [3] - The ProCellEx platform is noted for its cost efficiency and ability to express complex protein capabilities, positioning it as a leader in future biopharmaceutical developments [3] Market Position - The company is recognized as a hidden penny stock with potential for growth, likened to planting a tree that requires time and patience to flourish [2]
Protalix: Speculative Buy On Promising Plant-Cell Platform And Elfabrio Ramp
Seeking Alpha· 2025-08-25 10:57
Company Overview - Protalix BioTherapeutics (PLX) is a commercial-stage biotech company focused on recombinant therapeutic proteins [1] - The company utilizes its proprietary plant cell-based ProCellEx technology [1] Product Portfolio - Protalix has two approved enzyme replacement therapies: 1) Elfabrio for Fabry disease 2) Elelyso for Gaucher disease [1]
Protalix BioTherapeutics(PLX) - 2025 Q2 - Earnings Call Transcript
2025-08-14 13:30
Financial Data and Key Metrics Changes - The company experienced a 50% increase in revenues from selling goods compared to the same period last year [3] - Revenues from selling goods were $15.4 million for Q2 2025, an increase of $2.1 million or 16% compared to $13.3 million for Q2 2024 [12] - Net income for Q2 2025 was approximately $164,000 or $0 per share, compared to a net loss of approximately $2.2 million or $0.03 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by sales of Elfabrio to Chiesi, with an increase of $8 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Brazil and $1.2 million in sales to Pfizer [12] - Research and development expenses increased by $3 million or 100% to approximately $6 million in Q2 2025, primarily due to preparations for the planned Phase II clinical trial of PRX-115 [14] Market Data and Key Metrics Changes - The global market for Fabry disease is approximately $2.3 billion in 2025 and is forecasted to reach approximately $3.2 billion by 2030 [4] - The company anticipates El Fabryo royalties exceeding $100 million by 2030 based on a projected 15% to 20% market share of the estimated $3.2 billion Fabry total market [6] Company Strategy and Development Direction - The company is focused on building its product development pipeline, particularly in early-stage development assets and therapeutic areas related to renal rare diseases [8] - The company plans to initiate a Phase II study for PRX-115 in 2025 and enroll the first patient in Q4 2025 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic plan and the foundation being built for future growth, emphasizing the excitement around the Phase II program for PRX-115 [18] - The management noted that Chiesi has been performing better than expected in the marketplace, with significant growth in patient acquisition [28] Other Important Information - The company had $33.4 million in cash and cash equivalents and short-term bank deposits as of June 30, 2025 [16] - Eyal Rubens, the Chief Financial Officer, is stepping down after six years, and Gilad Mambloc will succeed him [9][10] Q&A Session Summary Question: Comments on Chiesi's planned study called Pagasso - Management confirmed it is part of Chiesi's phase four program to enhance the merits and strengths of the program [22][23] Question: Details on the Phase II trial for PRX-115 - The company plans to operate between 20 to 30 sites for the trial, primarily in the U.S. [24][25] Question: Market share held by Chiesi in Fabry disease - Management stated they do not disclose specific market share numbers but assured that Chiesi is performing well and growing its market share [27][28] Question: Utilization of Gilad's experience in business development - Management clarified that while Gilad has significant experience, the company is currently not planning any mergers or acquisitions and is focusing on growing its pipeline [30][32]
Protalix BioTherapeutics lifts revenue on strong Elfabrio demand
Proactiveinvestors NA· 2025-08-14 12:39
Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]
Protalix BioTherapeutics Is A Strong Buy With Increasing Revenues And A Promising Pipeline
Seeking Alpha· 2025-04-10 13:54
Company Overview - Protalix BioTherapeutics (PLX) is a biotechnology company that has two marketed therapies: Elelyso for Gaucher disease and Elfabrio for Fabry Disease [1] - The company is actively developing a clinical pipeline that may present future opportunities [1] Market Position - The presence of two marketed therapies positions Protalix BioTherapeutics as a player in the biotechnology sector focused on rare diseases [1]