logo
Plus   Neg
Share
Email

Protalix: FDA Extends PDUFA Action Date For Pegunigalsidase Alfa - Quick Facts

Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., announced the FDA has extended the PDUFA date for review of the Biologics License Application seeking accelerated approval of pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The BLA submission includes a set of preclinical, clinical, and manufacturing data compiled from the phase I/II clinical trial of pegunigalsidase alfa.

The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Facebook said it has launched an improved version of its automatic alternative text or AAT feature to improve photo descriptions for its users who are blind or visually impaired. AAT utilizes object recognition to generate descriptions of photos on demand so that blind or visually impaired, or BVI individuals, can more fully enjoy their News Feed. Morgan Stanley (MS) reported Wednesday a profit for the fourth-quarter that climbed 57 percent from last year, reflecting strong performance across all three business segments. Both earnings per share and quarterly revenue beat analysts' estimates. Billionaire and Alibaba co-founder Jack Ma made his first public appearance after nearly three months while delivering a speech to rural teachers in China in a live virtual meeting on Wednesday morning. He has been out of public view since late October, when he made a controversial speech at a Shanghai financial forum.
Follow RTT