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]

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

PARMA, Italy and CARMIEL, Israel, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have requested a re-examination of the recent negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the proposed dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio® (pegunigalsidase alfa). The opinion concerns the ...

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]

The Group moves into Fiscal 2026 on strengthened foundationsFiscal 2025 ResultsIssy-les-Moulineaux, France – 30 October 2025 Pluxee outperforms in Fiscal 2025, combining sustained growth, strong margin expansion and record cash generation The Group moves into Fiscal 2026 on strengthened foundations Highlights Robust commercial performance, with an increasing contribution from M&A synergies, reflecting disciplined execution of the strategic roadmap and the resilience of Pluxee’s business model in a challengi ...

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].

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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]

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]

Summary of Protalix BioTherapeutics Conference Call Company Overview - Protalix BioTherapeutics is a publicly traded company listed on NYSE American, with a unique technology for expressing complex human proteins through plant cells rather than mammalian cells [4][3] - The company has been operational for approximately 30 years [4] Core Products - Protalix has two FDA-approved drugs: - **El Eliza** for the treatment of Gaucher disease, licensed to Pfizer [8][10] - **El Fabrio** for the treatment of Fabry disease, licensed to Kiesi [8][18] - Both drugs are sold through partnerships, with annual sales to Pfizer and Brazil estimated at $22 to $24 million [13][12] Financial Performance - The manufacturing agreement with Pfizer for El Eliza expires in October 2030, with hopes to renegotiate for potential return of the drug [15] - The market for El Fabrio is expected to grow from $2.2 billion last year to $3.2 billion by the end of the decade, with Protalix potentially earning $100 to $120 million in royalties from Kiesi [17][20] - Protalix is currently well-capitalized with approximately $34 million in cash and zero debt [46] Pipeline and Future Prospects - The most advanced pipeline asset is **PRX-115**, targeting uncontrolled severe gout, with a significant patient population in the U.S. [9][36] - The company is exploring additional dosing regimens for its drugs, including a once-a-month option for El Fabrio, which is under review by the EMA [29][30] - Protalix aims to leverage its core competencies in rare renal diseases and is open to collaborations in this area [44] Market Dynamics - The competitive landscape includes other enzyme replacement therapies (ERTs) like Fabrazyme and Replagal, which require more frequent infusions compared to El Fabrio [27][41] - The agreement with Kiesi includes royalties of 15-40% on U.S. sales and 15-35% on international sales, along with potential milestone payments [18][20] Key Takeaways - Protalix's unique plant-based technology offers cost advantages and manufacturing flexibility [5][6] - The company is focused on maintaining operational stability while exploring growth opportunities in its pipeline [14][46] - Upcoming catalysts include the EMA's decision on the new dosing regimen and the initiation of Phase 2 trials for PRX-115 [53]