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Amicus Therapeutics, inc (FOLD) Q2 2021 Earnings Call Transcript fool.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fool.com Daily Mail and Mail on Sunday newspapers.
Amicus Therapeutics, inc (FOLD) Q2 2021 Earnings Call Transcript msn.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from msn.com Daily Mail and Mail on Sunday newspapers.
Operator Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics First Quarter 2021 Financial Results Conference Call and Webcast. [Operator Instructions] I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Head of Investor Relations. You may begin. Andrew Faughnan Thank you, Mary. Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics first quarter 2021 financial results and corporate highlights. Speaking on today s call, we have John Crowley, Chairman and Chief Executive Officer; Bradley Campbell, President and Chief Operating Officer; Daphne Quimi, Chief Financial Officer; and Dr. Jeff Castelli, Chief Development Officer. Joining for Q&A, we ll have Dr. Mitchell Goldman, Senior Vice President of Clinical Research joining. ....
Submissions to Seek Approval in both ERT Naïve and ERT Switch Pompe Patients Completion of Rolling Biologics License Application On-Track by end of 2Q21 PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) Amicus Therapeutics (NASDAQ:FOLD) today announced the completion of a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for AT-GAA (cipaglucosidase alfa co-administered with miglustat), its investigational two-component therapy for the treatment of Pompe disease. Based on this formal pre-BLA meeting and the final written communication received from the FDA, Amicus intends to complete the rolling BLA submission for cipaglucosidase alfa and submit a New Drug Application for miglustat. ....