Chiesi, Protalix Receive Positive CHMP Opinion For Pegunigalsidase Alfa To Treat Fabry Disease

RTTNews | vor 792 Tagen
Chiesi, Protalix Receive Positive CHMP Opinion For Pegunigalsidase Alfa To Treat Fabry Disease

(RTTNews) - Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX-102 (pegunigalsidase alfa), the first and only pegylated enzyme for the treatment of adult patients with Fabry disease.

PRX-102 is a novel recombinant human a-Galactosidase-A (a-Gal-A) enzyme being investigated as an enzyme replacement therapy (ERT) for the treatment of Fabry disease.

The positive CHMP opinion was based on a marketing authorization application (MAA) that includes positive data from a comprehensive set of preclinical, clinical and manufacturing studies evaluating PRX-102.

The CHMP opinion is now referred for final action to the European Commission (EC). A final EC decision on the MAA is expected in the beginning of May 2023.

read more
Swiss Market Ends Modestly Higher

Swiss Market Ends Modestly Higher

The Swiss market closed modestly higher on Friday after moving in a tight bandwith investors digesting earnings updates and continuing to track the developments on the tariff front.
RTTNews | vor 18Std 53 Minuten
European Stocks Close Higher

European Stocks Close Higher

Despite lingering uncertainty about U.S. government's trade policy, European stocks closed higher on Friday, with German and French markets gaining for a fourth straight session, and the U.K. moving up for the tenth consecutive session, as investors focused on earnings.
RTTNews | vor 19Std 11 Minuten
U.S. Consumer Sentiment Deteriorates Modestly Less Than Estimated In April

U.S. Consumer Sentiment Deteriorates Modestly Less Than Estimated In April

A report released by the University of Michigan on Friday showed consumer sentiment in the U.S. deteriorated modestly less than previously estimated in the month of April. The University of Michigan said its consumer sentiment index for April was upwardly revised to 52.2 from a preliminary reading of 50.8. Economists had expected the index to be unrevised.
RTTNews | vor 21Std 29 Minuten