Protalix BioTherapeutics Stock Tumbled 28% Today: Why The Latest CHMP Opinion Is Sparking Concerns Among Investors?

However, Protalix CEO said that the results of the review do not change the priority of the company to reduce treatment burden for patients with Fabry disease.

Protalix BioTherapeutics (PLX) and Chiesi Global Rare Diseases announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the request to approve a new dosing regimen for Elfabrio.

The company is seeking approval of a dosing regimen of 2 mg/kg body weight infused every four weeks for Elfabrio. The currently approved dosing regimen in the European Union is 1 mg/kg body weight infused every two weeks for the treatment of adults with confirmed Fabry disease, a rare genetic disorder leading to the buildup of a fatty substance called globotriaosylceramide in cells throughout the body.

However, Protalix CEO said that the results of the review do not change the priority of the company to reduce treatment burden for patients with Fabry disease.

Shares of PLX dropped 28% in the pre-market session at the time of writing. 

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