About
Protalix BioTherapeutics is a biopharmaceutical company focused on the development, production, and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant-cell-based protein expression system. The company's pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets. Protalix gained FDA approval for a plant-cell culture-expressed protein. Elelyso (taliglucerase alfa for injection) is the company's first drug product produced by ProCellEx. Elelyso was approved for marketing by the FDA in May 2012, soon followed by approval from multiple regulatory agencies including the EMA, Australian TGA, Brazilian ANVISA, and the Israeli Ministry of Health. The product has been licensed to Pfizer. The Protalix ProCellEx platform has the ability to manufacture complex proteins, antibodies, and vaccines and to orally deliver certain therapeutic proteins as demonstrated in animal models.
Funding history · 4 rounds · $159.9M total
Company Intelligence Q&A
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- What was a significant regulatory approval Protalix BioTherapeutics received in May 2012?
- In May 2012, Protalix BioTherapeutics received FDA approval for Elelyso (taliglucerase alfa for injection), its first drug product produced by the ProCellEx platform. This was followed by approvals from the EMA, Australian TGA, Brazilian ANVISA, and the Israeli Ministry of Health.
- Which company licensed Protalix BioTherapeutics' drug product Elelyso?
- Protalix BioTherapeutics licensed its drug product Elelyso to Pfizer.
- What was the outcome of the collaboration between Protalix BioTherapeutics and Chiesi Global Rare Diseases regarding Elfabrio in the EU in March 2026?
- In March 2026, Protalix BioTherapeutics and Chiesi Global Rare Diseases announced European Commission approval for an additional 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio (pegunigalsidase alfa).
- What was a key financial event for Protalix BioTherapeutics in March 2020?
- In March 2020, Protalix BioTherapeutics raised $43.7 million in financing, with investors including Psagot Investment House and More Investment House.
- What significant partnership did Protalix BioTherapeutics enter into in February 2021?
- In February 2021, Protalix BioTherapeutics entered into an exclusive partnership with SarcoMed USA to develop alidornase alfa for the treatment of pulmonary sarcoidosis and related respiratory diseases via inhaled delivery.
- What was the outcome of the FDA's review of pegunigalsidase alfa in April 2021?
- In April 2021, Protalix BioTherapeutics and Chiesi Global Rare Diseases received a Complete Response Letter for pegunigalsidase alfa from the FDA.
- What was the status of Protalix BioTherapeutics' common stock on the Tel Aviv Stock Exchange in December 2022?
- In December 2022, Protalix BioTherapeutics announced its intention to delist its common stock from the Tel Aviv Stock Exchange.
- What was a significant regulatory achievement for Protalix BioTherapeutics in May 2023?
- In May 2023, Protalix BioTherapeutics and Chiesi Global Rare Diseases announced FDA approval of ELFABRIO® (pegunigalsidase alfa-iwxj) for the treatment of Fabry Disease.
- What was a financial milestone Protalix BioTherapeutics announced in May 2023?
- In May 2023, Protalix BioTherapeutics announced a $20 million milestone payment from Chiesi Global Rare Diseases.
- What was the status of Protalix BioTherapeutics' PRX-115 clinical trial in March 2023?
- In March 2023, Protalix BioTherapeutics announced that the first patient was dosed in the first-in-human Phase I clinical trial of PRX-115 for the treatment of severe gout.