Protalix BioTherapeutics, Inc. [AMEX: PLX] stock has plunged 39.66% during the trading session of Wednesday. The negative performance of the company indicated the negative reaction of the investors after the firm disclosed that it has got the complete Response Letter (CRL) from the FDA regarding the marketing application of pegunigalsidase alfa (PRX‑102) for Fabry disease.
The firm has submitted the complete application for PRX-102 which comprises a comprehensive set of preclinical, clinical, and manufacturing data gathered from the concluded Phase 1/2 clinical study of PRX-102. Presently, PRX‑102 is in Phase III study BALANCE study funded by Protalix and various long-term extension studies.
Shares of Protalix BioTherapeutics plummeted 39.48% as it lost -2.30 at the time of writing on Wednesday. The firm has reported a trading volume of 7.93 million as compared to the average volume of 1.12 million. In the past 52-weeks of the trading session, the share of the firm wavered $2.81 and $7.02 during the past 52-week of low and high range. Protalix’s total market capitalization has reached $264.58 million at the time of writing.
Furthermore, the firm has revealed that along with Chiesi the firms have started studying the CRL to evaluate the most practical administrative procedure to reach an opinion with the FDA on further actions needed to get permission for PRX‑102. the firm will soon give the updates.
The firm has stated that the CRL it has received from the FDA disappointed the firm but it has full confidence in the strength of our data and in the depth of its program. Protalix will continue its work with FDA and Chiesi to get the authorization for PRX-102.