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Chiesi and Protalix Update on Elfabrio Progress
Chiesi Global Rare Diseases and Protalix BioTherapeutics announced an update on Elfabrio. The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks dosing regimen for Elfabrio in Fabry disease adult patients stable with an ERT treatment. This positive opinion follows the CHMP's re-examination of the company's application for the additional dosing regimen.
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.
Protalix Announces Q3 Earnings Per Share of 3 Cents, Below Consensus Estimate of 5 Cents
Reports Q3 revenue $17.85M, consensus $17.87M. "We are pleased to report total revenues of $43.6 million for the first nine months of 2025, an increase of 24%, compared to the same period in 2024. Our total revenues for the third quarter were $17.9 million which reflects a decrease of 1%, compared to revenues for the same period of 2024," said Dror Bashan, Protalix's President and Chief Executive Officer. "We recognize revenues from sales of our products to Chiesi, Pfizer, and Fiocruz in Brazil, and their purchases vary from quarter to quarter as they control their own inventories. Overall, these revenues reflect the continued commercial success of our enzyme replacement therapies and provide a strong foundation to support our research and development efforts."
Protalix and Chiesi Global Receive Negative CHMP Opinion for Elfabrio
Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics acknowledge that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks for Elfabrio. "We are disappointed by the result of this review but want to express our immense appreciation for the collaboration of the patient community, researchers and European Commission throughout this process," said Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases. "We are proud to be a part of this community and will continue to prioritize the potential to advance and evolve safe and effective solutions for Fabry disease with reduced treatment burden."
Protalix appoints Gilad Mamlok as CFO
Protalix announced the appointment of Gilad Mamlok to serve as the company's new senior VP and CFO, effective August 24, succeeding Eyal Rubin. Mamlok has joined the company and is working alongside Rubin. Most recently, he served as the Chief Financial Officer of TytoCare. After his tenure as CFO ends, Rubin will continue to be available to the company as necessary until October.
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