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

Protalix BioTherapeutics Inc 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 (PRX‑102) 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.
PRX‑102 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 PRX‑102 in the European Union this year.
Price Action: PLX shares drop 38.3% at $3.6 in the premarket on the last check Wednesday.