Protalix BioTherapeutics and Chiesi Farmaceutici Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the Uni...
Protalix BioTherapeutics, Inc. (DE) (PLX)
NASDAQ:AMEX Investor Relations:
phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-irhome
Company Research
Source: PR Newswire
CARMIEL, Israel, Nov. 18, 2019 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and its development and commercialization partner, Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi), today announced that they have completed a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) regarding the Accelerated Approval pathway for pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. The Company, together with Chiesi, met with the FDA on October 15 to discuss key information on pegunigalsidase alfa to be included in a proposed BLA filing under the Accelerated Approval pathway. The Company and Chiesi report that they have reached alignment with t
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PLX
Earnings
- 11/14/24 - Miss
PLX
Sec Filings
- 11/14/24 - Form 10-Q
- 11/14/24 - Form 8-K
- 11/5/24 - Form 4/A
- PLX's page on the SEC website