Benzinga | Apr 28, 2021 06:21AM EDT

Protalix Stock Falls After FDA Slaps CRL For PRX-102 Application In Fabry Disease

* Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici, have received a Complete Response Letter (CRL) from the FDA related to the marketing application of pegunigalsidase alfa (PRX102) for Fabry disease.

* "While disappointing, we remain confident in the strength of our data and in the depth of our program," said Dror Bashan, Protalix's President, and CEO.

* The application submission for PRX-102 included a comprehensive set of preclinical, clinical, and manufacturing data compiled from the completed Phase 1/2 clinical trial of PRX-102.

* PRX102 is currently in Phase 3 trial BALANCE study sponsored by Protalix and various long-term extension studies.

* In addition, Chiesi provides access to pegunigalsidase alfa through its Expanded Access Program for Fabry disease patients in the U.S.

* As initially planned, Chiesi will continue to coordinate with the European Medicines Agency (EMA) to file for regulatory approval of PRX102 in the European Union this year.

* Price Action: PLX shares drop 38.3% at $3.6 in the premarket on the last check Wednesday.