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  • News bot April 23, 2026, 8:11 p.m.

    📋 AMICUS THERAPEUTICS, INC. (FOLD) - Regulatory Update

    Filing Date: 2026-04-23

    Accepted: 2026-04-23 16:09:53

    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: None Clinical Development:
    • anticipated in these forward-looking statements. Except as required by law, each of BioMarin and Amicus assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent each of BioMarin's and Amicus' current expectations or beliefs concerning various future events that are subject to significant risks and uncertainties, may contain words such as "may," "will," "would," "could," "expect," "anticipate," "intend," "plan," "believe," "estimate," "project," "seek," "should," "strategy," "future," "opportunity," "potential" or other similar words and expressions indicating future results. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Forward-looking statements reflect current beliefs and expectations; however, these statements involve inherent risks and uncertainties, including, without limitation, with respect to: consummating the Merger in the anticipated time frame, if at all; the time-consuming and uncertain regulatory approval process; any legal proceedings related to the Merger; and other risks and uncertainties affecting BioMarin and Amicus, including those risk factors detailed in BioMarin's and Amicus' filings with the Securities and Exchange Commission, including, without limitation, the risk factors contained under the caption "Risk Factors" in BioMarin's Annual Report on Form 10-K for the fiscal year ended December 31, 2025

    🔬 Clinical Development Pipeline (AMICUS THERAPEUTICS, INC.):

    Product Type Development Stage Therapeutic Area Source
    ERT DRUG Preclinical Fabry Disease ClinicalTrials.gov
    migalastat HCl DRUG Preclinical Fabry Disease ClinicalTrials.gov
    Migalastat HCl 20 mg DRUG Phase PHASE3 Fabry Disease ClinicalTrials.gov
    Untreated OTHER Preclinical Pompe Disease ClinicalTrials.gov
    Alglucosidase alfa or Avalglucosidase alfa BIOLOGICAL Preclinical Pompe Disease ClinicalTrials.gov
    Miglustat DRUG Preclinical Pompe Disease ClinicalTrials.gov
    Cipaglucosidase alfa BIOLOGICAL Preclinical Pompe Disease ClinicalTrials.gov
    Dexamethasone DRUG Phase PHASE2 Nausea and Vomiting, Postoperative ClinicalTrials.gov
    Amisulpride Injection DRUG Phase PHASE2 Nausea and Vomiting, Postoperative ClinicalTrials.gov
    This is a non-interventional study OTHER Preclinical Fabry Disease ClinicalTrials.gov
    Noninterventional OTHER Preclinical Fabry Disease ClinicalTrials.gov
    AT2221 DRUG Preclinical Pompe Disease Infantile-Onset ClinicalTrials.gov
    ATB200 BIOLOGICAL Preclinical Pompe Disease Infantile-Onset ClinicalTrials.gov
    Enzyme Replacement Therapy (ERT) DRUG Preclinical Fabry Disease ClinicalTrials.gov
    AT-GTX-501 GENETIC Preclinical CLN6 ClinicalTrials.gov
    migalastat DRUG Preclinical Fabry Disease ClinicalTrials.gov
    Endothelial function biomarkers BIOLOGICAL Approved Hypertrophic Cardiomyopathy ClinicalTrials.gov
    BNP blood sample test BIOLOGICAL Approved Hypertrophic Cardiomyopathy ClinicalTrials.gov
    migalastat HCl 150 mg DRUG Phase PHASE3 Fabry Disease ClinicalTrials.gov
    Noninterventional characterization of patients expectations and preferences regarding their treatment BEHAVIORAL Preclinical Fabry Disease ClinicalTrials.gov
    Placebo DRUG Phase PHASE3 Pompe Disease (Late-onset) ClinicalTrials.gov
    Alglucosidase Alfa BIOLOGICAL Phase PHASE3 Pompe Disease (Late-onset) ClinicalTrials.gov
    Survey OTHER Preclinical Epidermolysis Bullosa ClinicalTrials.gov
    SD-101-6.0 cream DRUG Phase PHASE3 Epidermolysis Bullosa ClinicalTrials.gov
    Placebo (SD-101-0.0) cream DRUG Phase PHASE3 Epidermolysis Bullosa ClinicalTrials.gov
    Diet and Exercise OTHER Approved Pompe Disease ClinicalTrials.gov
    Zavesca® Prescription DRUG Phase PHASE1 Pompe Disease ClinicalTrials.gov
    SD-101 dermal cream (6%) DRUG Phase PHASE2 Epidermolysis Bullosa 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
    Vehicle (SD-101 0%) DRUG Phase PHASE2 Epidermolysis Bullosa ClinicalTrials.gov
    SD-101 dermal cream (3%) DRUG Phase PHASE2 Epidermolysis Bullosa 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
    [14C] AT1001 DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov
    AT1001 150 mg DRUG Phase PHASE1 Fabry Disease ClinicalTrials.gov
    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
    migalastat hydrochloride DRUG Phase PHASE3 Fabry Disease ClinicalTrials.gov
    rhGAA DRUG Phase PHASE2 Pompe Disease ClinicalTrials.gov
    duvoglustat DRUG Phase PHASE2 Pompe Disease ClinicalTrials.gov
    agalsidase BIOLOGICAL Phase PHASE3 Fabry Disease ClinicalTrials.gov
    Agalsidase Alfa BIOLOGICAL Phase PHASE2 Fabry Disease ClinicalTrials.gov
    Agalsidase Beta BIOLOGICAL Phase PHASE2 Fabry Disease ClinicalTrials.gov
    AT2101 DRUG Phase PHASE1 Type 1 Gaucher Disease ClinicalTrials.gov
    afegostat tartrate DRUG Phase PHASE2 Gaucher Disease ClinicalTrials.gov
    Observation OTHER Preclinical Pompe Disease ClinicalTrials.gov
    Blood sample PROCEDURE Preclinical Gaucher Disease ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: AMICUS THERAPEUTICS, INC.
    • Ticker Symbol: FOLD

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