FOLD News and Press, Amicus Therapeutics Inc. From 02/11/21

Amicus Therapeutics (FOLD) has lost 21.3% in the post market after the company announced the topline results of its Phase 3 PROPEL pivotal trial for AT-GAA in the treatment of late-onset Pompe disease (“LOPD”).The 52-week, double-blind randomized global study evaluates...

Rolling BLA submission for AT-GAA planned for completion in Q2 and other global regulatory submissions for approval expected throughout 2021 Patients switching to AT-GAA from the approved standard of care ERT (alglucosidase alfa) walked on average 17 meters farther (p=0.046)...

Amicus Therapeutics ([[FOLD]] -1.2%) announced what it called the ‘positive initial results’ for its gene therapy candidate, AT-GTX-502, currently undergoing a Phase 1/2 study in classic juvenile neuronal ceroid lipofuscinosis (“JNCL”), also known as CLN3...

Amicus Optimized Transgene Show Greater Substrate Reduction than Wild Type Construct Across All Tissues and Doses Further Validates Combining Amicus-Engineered Transgenes with Penn’s AAV Gene Therapy Technologies to Develop Next Generation Gene Therapies PHILA...

Initial Data Suggest Early Signs of Disease Stabilization in Children with Fatal Neurologic Disease Plan to Submit IND for Next Clinical Study in 2H2021 PHILADELPHIA, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced posit...

Amicus Therapeutics (FOLD) share are up 6.7% in morning trading after a Dealreporter piece speculated it may be a takeout target for Vertex (VRTX).The article also points out Biomarin (BMRN) could be a Vertex acquisition target, though shares of that company are down 0.3% right now....

Amicus Therapeutics (FOLD) has filed an automatic shelf registration with the SEC for the resale of up to 2,554,999 underlying warrants to purchase shares.The company filed the SEC Form S-3 on Jan. 29, but then amended it on Feb. 2 due to a filing error.Maximum aggregate offering price is $48...

CRANBURY, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today announced that three oral presentations and ten posters highl...

Amicus Therapeutics (FOLD) provides preliminary Galafold revenue for FY 2020 to ~$261M exceeding guidance of $250-$260M, driven by strong adoption and patient adherence.To achieve continued double-digit growth and Galafold revenue of at least $300M for FY 2021.The Co. strengthened Galafold IP...

Full-Year 2020 Galafold ® Revenue of ~$261M Exceeds Guidance Strengthened Galafold IP Portfolio Now Includes 24 Issued Patents Including 13 Patents through 2038 Pompe Phase 3 PROPEL Study Last Patient, Last Visit Complete with Data...