FOLD News and Press, Amicus Therapeutics Inc. From 01/15/23

Summary AT-GAA's US approval is still held up by the China delay. Meanwhile, the company faces the risk of appearing overvalued. Impending IP challenges pose major risks. There is no further clarity on the delay of the NDA from Amicus Therapeutics ( FOLD ) for AT-GAA (...

Significant Growth in Demand with More Than 2,000 People Living with Fabry Disease on Galafold by End of 2022 2022 Full Year Revenue of ~$329M, Representing 16% YoY Growth at CER Continued Double-Digit Growth in Galafold Revenue of 12-17% at CER Expected in 2023 ...

PHILADELPHIA, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that Bradley Campbell, President and Chief Executive Officer, will present at the 41 st Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 9, 2023 at 2:15 p.m. PT. ...

CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data CHMP Recommends Label for Long-Term Enzyme Replacement Therapy in Combination with Miglustat for both ERT-Experienced and Treatment-Naïve Adults Living with Late-Onset Pom...

PHILADELPHIA, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in a fireside chat at the Stifel 2022 Healthcare Conference in New York, NY on Wednesday, November 16, 2022 at 9:45 a.m. E.T. A live audio webcast of the...

Amicus Therapeutics ( NASDAQ: FOLD ) announced Monday that an advisory panel of the European Medicines Agency (EMA) would not conduct oral explanations for experimental therapies miglustat and cipaglucosidase alfa that make up its lead program, AT-GAA. The update comes after...

Amicus Therapeutics Inc. (FOLD) Q3 2022 Earnings Conference Call November 7, 2022 8:30 am ET Company Participants Bradley Campbell - President, Chief Executive Officer Sébastien Martel - Chief Business Officer Jeff Castelli - Chief Development Officer Da...

PHILADELPHIA, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today provided an EU regulatory update for AT-GAA. Earlier this morning, ...

Amicus Therapeutics press release ( NASDAQ: FOLD ): Q3 GAAP EPS of -$0.12 beats by $0.08 . Revenue of $81.7M (+2.7% Y/Y) misses by $2.5M . On-track to deliver Full-Year 2022 double-digit revenue growth of 15-20% at CER vs. consensus of 11% Y/Y growth. Upd...

Year-to-Date 2022 Reported Revenue Growth of 8% (16% at CER) On-Track to Deliver Full-Year 2022 Double-Digit Revenue Growth of 15-20% at CER Advancing Launch Preparation for AT-GAA in Pompe Disease Updating Full-Year 2022 Non-GAAP Operating Expense ...