Protalix BioTherapeutics(PLX)
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Pluxee acknolwedges the Brazilian government’s communication on the Workers’ Food Program (PAT)
Globenewswire· 2025-11-11 23:31
Core Viewpoint - The Brazilian government's recent changes to the Workers' Food Program (PAT) could jeopardize its long-term sustainability and may lead to increased risks of misuse and non-compliance [2][4]. Group 1: Government Measures - The new measures regarding the merchant discount rate (MDR), reimbursement deadlines, and voucher processing are set to take effect in 90 days [2]. - These measures diverge significantly from prior discussions between the industry association (ABBT) and the government [2]. Group 2: Company Concerns - The changes interfere with private commercial relations and limit issuers' ability to innovate and compete [4]. - The company is considering legal action against the implementation of these measures, both independently and in collaboration with ABBT [4]. Group 3: Historical Context - Since the creation of the PAT over 40 years ago, the company has played a significant role in its expansion by providing innovative solutions and value to various stakeholders [3]. Group 4: Future Actions - Following the publication of the decree, the company will conduct a thorough assessment of the potential financial implications and develop a mitigation plan [4].
Disclosure Fiscal 2026/01 of Transactions on Treasury Shares
Globenewswire· 2025-11-10 16:45
Core Insights - Pluxee N.V. disclosed transactions on treasury shares for the period from October 31 to November 7, 2025, indicating ongoing share buyback activities [1][3]. Summary by Category Treasury Share Transactions - On October 31, 2025, Pluxee acquired a total of 43,069 shares across three transactions at weighted average prices of €17.3161, €17.1802, and €17.2366 on different platforms [3]. - On November 3, 2025, the company purchased 35,800 shares at a weighted average price of €17.2350 and €17.1985 [3]. - On November 4, 2025, a total of 40,768 shares were acquired at weighted average prices of €16.6720 and €16.5760 [3]. - On November 5, 2025, Pluxee bought 41,092 shares at prices ranging from €16.5397 to €16.5799 [3]. - On November 6, 2025, the company acquired 46,936 shares at prices between €16.2583 and €16.1604 [3]. - On November 7, 2025, a total of 44,405 shares were purchased at weighted average prices of €15.3456, €15.2952, and €15.2900 [3]. Company Overview - Pluxee operates in the Employee Benefits and Engagement sector, providing solutions in Meal & Food, Well-being, Lifestyle, Reward & Recognition, and Public Benefits across 28 countries [4]. - The company has over 5,600 employees and serves more than 500,000 clients, impacting over 37 million consumers and 1.7 million merchants [4]. - With over 45 years of experience, Pluxee is committed to enhancing employee well-being and supporting local communities [4].
Pluxee convenes its Fiscal 2025 Annual General Meeting of shareholders
Globenewswire· 2025-11-05 07:30
Core Points - Pluxee has announced its Fiscal 2025 Annual General Meeting of shareholders scheduled for December 17, 2025, at 2:00 pm CET in Amsterdam-Schiphol, Netherlands [1] - All relevant documents for the Annual General Meeting, including the agenda and voting instructions, are available on the Pluxee Group website [2] - Pluxee operates in 28 countries, providing a range of Employee Benefits and Engagement solutions, and has over 500,000 clients and 37 million consumers [3] Company Overview - Pluxee is a global player in Employee Benefits and Engagement, focusing on attracting, engaging, and retaining talent through various solutions [3] - The company has been in operation for more than 45 years and employs over 5,600 team members [3] - Pluxee is committed to creating a positive impact on local communities and supporting employee well-being while also focusing on environmental protection [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]
Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU
Globenewswire· 2025-11-03 21:30
Core Viewpoint - Chiesi Global Rare Diseases and Protalix BioTherapeutics have requested a re-examination of the negative opinion from the CHMP regarding the proposed dosing regimen for Elfabrio® (pegunigalsidase alfa) [1][2] Company Overview - Chiesi Global Rare Diseases is a business unit of the Chiesi Group, focused on delivering innovative therapies for rare diseases [16] - Protalix BioTherapeutics specializes in developing recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx [18] Product Information - Elfabrio® is indicated for the treatment of adults with confirmed Fabry disease [3] - The current approved dosing regimen is 1 mg/kg every 2 weeks, while a new regimen of 2 mg/kg every 4 weeks is under review [2] Clinical Trial Insights - In clinical trials, 14% of patients treated with Elfabrio experienced hypersensitivity reactions, with 3% experiencing anaphylaxis [6] - Infusion-associated reactions were reported in 29% of patients, including symptoms such as nausea, chills, and rash [7][9] Regulatory Context - The existing marketing authorization for Elfabrio remains effective while the re-examination process is ongoing [2] - The outcome of the re-examination will influence the final decision by the European Commission [2] Disease Background - Fabry disease is a rare inherited lysosomal storage disorder caused by mutations in the GLA gene, leading to enzyme deficiency and accumulation of globotriaosylceramide (GL-3) [11][12] - Symptoms include fatigue, chronic pain, and increased risk of serious complications such as kidney failure and stroke [11][12]
PLX Investors Have Opportunity to Join Protalix BioTherapeutics, Inc. Fraud Investigation with the Schall Law Firm
Businesswire· 2025-11-01 00:31
Core Viewpoint - Protalix BioTherapeutics, Inc. is currently under investigation for potential fraud, providing an opportunity for investors to join the investigation led by the Schall Law Firm [1] Group 1 - The investigation pertains to allegations of fraud involving Protalix BioTherapeutics, which may impact the company's financial standing and investor confidence [1] - Investors are encouraged to participate in the investigation to explore their legal options regarding potential losses incurred [1]
Pluxee Fiscal 2025 Results
Globenewswire· 2025-10-30 06:00
Core Insights - Pluxee demonstrated strong performance in Fiscal 2025, achieving sustained growth, significant margin expansion, and record cash generation, setting a solid foundation for Fiscal 2026 [1][6][7] Financial Performance - Total Revenues reached €1,287 million, reflecting a 10.6% organic growth and a 6.4% reported growth compared to Fiscal 2024 [2][14] - Recurring EBITDA increased to €471 million, marking a 22.2% organic growth and a 9.4% reported growth, with a recurring EBITDA margin of 36.6%, up 230 basis points organically [2][24][25] - Operating profit (EBIT) grew by 34.3% to €335 million, while net profit for the year attributable to the Group increased by 48.6% to €197 million [2][29][32] - Adjusted net profit attributable to the Group reached €221 million, an 8.4% increase year-on-year, with adjusted earnings per share of €1.52, up 9.1% [2][34][35] Cash Flow and Financial Position - Recurring free cash flow generation was €417 million, up 10.0%, resulting in a recurring cash conversion rate of 89%, exceeding the 75% target [2][36][41] - The net financial cash position improved to €1,163 million, an increase of €108 million year-on-year, supported by strong cash flow generation [2][42] Business Segments and Growth Drivers - Employee Benefits business volumes issued reached €18.7 billion, reflecting a 7.6% organic growth, with a net retention rate maintained at 100% [11][12] - Other Products & Services business volumes remained stable at €5.8 billion, impacted by the discontinuation of large Public Benefits programs [13][19] - The Group's strategic acquisitions, including Cobee and Benefício Fácil, contributed to growth and market position enhancement [46][47][49] Shareholder Returns and Future Outlook - A dividend of €0.38 per ordinary share was proposed, representing a 9% increase year-on-year, alongside a €100 million share buyback program [52][54] - For Fiscal 2026, Pluxee aims for high single-digit organic growth in Total Revenues, a 100 basis points increase in Recurring EBITDA margin, and an average recurring cash conversion above 80% [6][60]
Why Is Protalix BioTherapeutics Stock Falling On Friday?
Benzinga· 2025-10-17 15:23
Core Opinion - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion regarding the revised dosing schedule for Elfabrio, a treatment for Fabry disease, proposed by Protalix BioTherapeutics and Chiesi Group [1][2]. Company Overview - Protalix BioTherapeutics and Chiesi Group are facing selling pressure following the CHMP's decision [2][5]. - The companies had requested approval for a new dosing regimen of 2 mg/kg body weight infused every 4 weeks, in addition to the currently approved regimen of 1 mg/kg body weight infused every 2 weeks [2]. Clinical Data - The CHMP review was based on data from the BRIGHT trial and an ongoing open-label extension study, which collectively provided a median exposure of almost six years [3][4]. - The data from these studies, along with modeling and exposure-response analyses from prior trials, were deemed insufficient to demonstrate similar efficacy for the new dosing schedule [4]. Market Impact - Following the negative opinion, Protalix BioTherapeutics' stock price decreased by 29.83%, closing at $1.68 [5].
Protalix, Chiesi reaffirm commitment to Fabry disease patients after EMA panel setback
Proactiveinvestors NA· 2025-10-17 12:26
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 content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU
Globenewswire· 2025-10-17 10:58
Core Insights - Chiesi Global Rare Diseases and Protalix BioTherapeutics received a negative opinion from the CHMP of the EMA regarding the approval of a new dosing regimen for Elfabrio (pegunigalsidase alfa) [1][2] - The proposed regimen of 2 mg/kg every 4 weeks was not deemed to have sufficient efficacy compared to the currently approved regimen of 1 mg/kg every 2 weeks [1][2] Company Overview - Chiesi Global Rare Diseases is a unit of the Chiesi Group focused on innovative therapies for rare diseases [1][16] - Protalix BioTherapeutics specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system [1][19] - Both companies are committed to reducing the treatment burden for patients with Fabry disease [2][20] Clinical Trial Insights - The CHMP review was based on data from the BRIGHT trial and its extension study, which had a median exposure of almost six years [2] - The data from these studies, along with modeling and exposure-response analyses from prior trials, were insufficient to demonstrate similar efficacy for the new dosing regimen [2] Fabry Disease Context - Fabry disease is a rare lysosomal storage disorder caused by mutations in the GLA gene, leading to serious health complications [11][12] - Early detection and access to treatment are critical for managing symptoms and slowing disease progression [12] Safety Information - Elfabrio is indicated for adults with confirmed Fabry disease and has been associated with hypersensitivity reactions, including anaphylaxis [3][4] - In clinical trials, 14% of patients experienced hypersensitivity reactions, with 3% experiencing anaphylaxis [6][9]