Amicus Therapeutics Inc (FOLD) Event May 10, 2022, 20:01 UTC (99% Neutral tone) AMICUS THERAPEUTICS, INC. (FOLD) Announces Regulatory Update Full text
Register to leave comments News bot Sept. 24, 2025, 7:25 p.m. 📋 AMICUS THERAPEUTICS, INC. (FOLD) - Regulatory Update Filing Date: 2022-05-10 Accepted: 2022-05-10 16:01:28 Event Type: Regulatory Update Event Details: Amicus Therapeutics Inc (FOLD) Announces Regulatory Update Amicus Therapeutics Inc (FOLD) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: • PDUFA Date: may 10, 2022 • PDUFA Review Period Extended • Applications: BLA (Biologics License Application), NDA (New Drug Application), MAA (Marketing Authorization Application) • Designations: Breakthrough Therapy • Regulatory Agencies: FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency) • Status: Approved, Rejected, Extended Review • Committee Actions: CHMP Opinion Clinical Development: • Phase 3 trial ongoing • Data expected in 2022 expected in late 2022 🔬 Clinical Development Pipeline (AMICUS THERAPEUTICS, INC.): Product Type Development Stage Therapeutic Area Source E (migalastat) DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov D (migalastat) DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov C (migalastat) DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov B (migalastat) DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov A (migalastat) DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov [14C] AT1001 DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov Placebo capsule DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov Potable water OTHER Phase PHASE1 Fabry Disease ClinicalTrials.gov GR181413A/AT1001 capsule DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov GR181413A/AT1001 solution DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov oral migalastat HCl DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov IV placebo DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov IV migalastat HCl DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov 💼 Business Developments: Partnership: Not availableAcquisition: Not availableLicensing: Not availableRegulatory ApprovalExecutive Changes: Not available Structured Data: Company Name: Amicus Therapeutics IncCIK: 0001178879Ticker Symbol: FOLDPeriod End Date: 2022-05-10Document Type: 8-K
📋 AMICUS THERAPEUTICS, INC. (FOLD) - Regulatory Update
Filing Date: 2022-05-10
Accepted: 2022-05-10 16:01:28
Event Type: Regulatory Update
Event Details:
🔬 Clinical Development Pipeline (AMICUS THERAPEUTICS, INC.):
💼 Business Developments:
Structured Data: