Protalix Biotherapeutics, Inc. is a biopharmaceutical company, which engages in the development, production, and commercialization of recombinant therapeutic proteins based on plant cell based expression system. Its products include Alidornase alfa, PRX-115 and PRX-11. The company was by Yoseph Shaaltiel in 1993 and is headquartered in Hackensack, NJ.
相关临床试验
15
15 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
15
100.0%
暂无批准数据
- Protalix BioTherapeutics and Secarna Pharmaceuticals have entered a collaboration agreement to develop antisense oligonucleotide therapies for rare renal indications using AI-powered drug discovery. - The partnership combines Protalix's rare disease expertise with Secarna's proprietary OligoCreator® platform to advance programs from preclinical stage to clinical trials. - Protalix receives an exclusive option to license any active compounds derived from the research for potential clinical development and commercialization worldwide. - This collaboration marks Protalix's first expansion into rare kidney disease space using RNA technologies, demonstrating implementation of their updated research strategy.
- The European Medicines Agency's CHMP issued a negative opinion on Chiesi and Protalix's request to approve a less frequent dosing regimen for Elfabrio, rejecting the every-four-week option for Fabry disease patients. - The rejection was based on insufficient data from the BRIGHT trial and extension study to demonstrate similar efficacy compared to the currently approved every-two-week dosing schedule. - Despite the setback, both companies remain committed to reducing treatment burden for Fabry disease patients and will continue supporting the rare disease community. - Elfabrio remains approved for treating adults with confirmed Fabry disease at the current 1 mg/kg every two weeks dosing regimen in both the EU and US markets.
- The gout therapeutics pipeline has expanded significantly with over 20 companies developing 25+ novel drugs across various clinical stages, addressing critical unmet needs in gout management. - Recent clinical milestones include Atom Therapeutics' ABP-671 achieving its primary endpoint in Phase IIb/III trials and multiple FDA Fast Track designations for promising candidates. - Key pipeline therapies utilize diverse mechanisms of action including URAT1 inhibitors, xanthine oxidase inhibitors, and inflammasome inhibitors to target different aspects of gout pathophysiology. - The market is positioned for sustained growth driven by rising disease prevalence, increasing awareness, and strong demand for effective long-term management solutions.
- Protalix BioTherapeutics has appointed Gilad Mamlok as Senior Vice President and Chief Financial Officer, effective August 24, 2025, succeeding Eyal Rubin. - Mamlok brings three decades of experience in healthcare and technology companies, including roles at TytoCare, Sol-Gel Technologies, and Given Imaging. - The appointment comes as Protalix continues to advance its pipeline of plant cell-based therapeutic proteins, including approved products Elfabrio and taliglucerase alfa. - The company's proprietary ProCellEx platform represents the first FDA-approved protein production system using plant cell-based suspension expression technology.
- Protalix Biotherapeutics reported a 170% increase in Q1 product sales to $10 million, driven by higher sales to Pfizer and Brazil's Fiocruz, while narrowing its net loss to $3.6 million. - The company plans to initiate a Phase II clinical trial for PRX-115, its recombinant PEGylated uricase for uncontrolled gout, in the second half of 2025 following successful first-in-human studies. - Early data from PRX-115 trials suggests potential for infrequent dosing, which could improve long-term patient adherence in gout treatment, addressing a significant unmet need in this chronic condition.
- Protalix BioTherapeutics announced the validation by the EMA of Chiesi's variation submission for pegunigalsidase alfa, aiming for less frequent dosing for Fabry disease. - A Phase I clinical trial of PRX-115, a recombinant PEGylated uricase for uncontrolled gout, showed promising safety and efficacy results with potential for wide dosing intervals. - Protalix is refining its R&D strategy, focusing on plant-based drug delivery systems for renal rare diseases, leveraging its ProCellEx platform. - The company reported satisfaction with sales growth of Elfabrio to Chiesi, Elelyso to Pfizer, and Uplyso to Brazil, and has fully repaid its outstanding convertible notes.
- The EMA has validated an application for a less frequent Elfabrio (pegunigalsidase alfa) regimen for Fabry disease, potentially reducing treatment burden. - The proposed regimen involves administering Elfabrio every four weeks at 2 mg/kg, compared to the current bi-weekly regimen of 1 mg/kg. - The application is supported by data from the Phase 3 BRIGHT trial and its ongoing open-label extension study, demonstrating safety and efficacy. - If approved, this new regimen could offer Fabry patients in the EU a beneficial, alternative dosing option.
- The EMA has validated a variation submission for Elfabrio, proposing a less frequent dosing regimen for adult Fabry disease patients. - The new regimen suggests 2 mg/kg every four weeks, an alternative to the current 1 mg/kg bi-weekly dose. - Validation is supported by Phase 3 BRIGHT trial data, showing potential benefit for patients previously treated with other therapies. - This milestone aims to reduce treatment burden and improve the quality of life for Fabry disease patients.
- Protalix BioTherapeutics' PRX-115, a PEGylated uricase, shows promising dose-dependent urate-lowering effects in a Phase 1 study for individuals with gout. - The first-in-human study demonstrated that PRX-115 was well-tolerated, with most adverse events being mild to moderate and transient. - Single doses of PRX-115 rapidly reduced plasma urate levels, with the highest doses maintaining levels below 6.0 mg/dL for up to 12 weeks. - Protalix is actively planning a Phase 2 clinical trial of PRX-115 in gout patients, expected to begin in the second half of 2025.
- Protalix Biotherapeutics' PRX-115 shows dose-dependent reduction in plasma urate levels in Phase I trial for severe gout. - The Phase I trial demonstrated that PRX-115 was well-tolerated, with most adverse events being mild and resolving completely. - PRX-115 exhibited prolonged presence in plasma, up to 12 weeks, suggesting potential for less frequent dosing compared to existing treatments. - Protalix is planning a Phase II trial for PRX-115, with the trial design expected in the coming quarters and a launch anticipated in the second half of 2025.
