Protalix shares plummet by 44% on CRL news
Shares in Protalix BioTherapeutics (TASE: PLX) closed 44% lower on Wednesday after the firm and its partner Chiesi Farmaceutici announced receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for Fabry disease.
The Israeli pharma company stressed that the CRL did not report any concerns relating to the potential safety or efficacy of PRX–102 in the submitted data package.
In the CRL, the FDA noted that an inspection of Protalix' manufacturing facility in Carmiel, Israel, including its subsequent assessment of any related findings, is required before the agency can approve the BLA.
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