Protalix BioTherapeutics Stock Plunges 29.83% as CHMP Rejects Elfabrio Dosing Schedule

Protalix BioTherapeutics' (NYSE:PLX) stock is falling 29.83% to $1.68 after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for the company's and Chiesi Group's partnered Elfabrio's revised dosing schedule for Fabry disease. The CHMP deemed the data from the BRIGHT trial and ongoing open-label extension study insufficient to conclude on similar efficacy.

Protalix BioTherapeutics' (NYSE:PLX) stock has fallen by 29.83% to $1.68 following a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding the company's and Chiesi Group's Elfabrio dosing regimen for Fabry disease. The CHMP deemed the data from the BRIGHT trial and ongoing open-label extension study insufficient to conclude on similar efficacy for the proposed 4-week dosing regimen compared to the currently approved 2-week regimen.

The CHMP's decision was based on the lack of sufficient data from clinical trials and analyses to support the efficacy of the new dosing regimen. Despite the setback, Protalix and Chiesi remain committed to reducing treatment burdens for Fabry disease patients. Elfabrio continues to be approved for Fabry disease treatment in the EU, and both companies have expressed their intention to continue supporting the Fabry disease community despite this regulatory outcome.

Protalix's stock has been significantly impacted by this news, with shares tumbling 20.8% in premarket trading on Friday after the CHMP's decision. The companies have stated that they will continue to work together to support the Fabry disease community and potentially address the regulatory concerns raised by the CHMP.