| Drug / Therapy | A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects A |
| Indication | — |
| Decision Type | Phase 3 |
| Trial Phase | Phase 3 |
| ClinicalTrials.gov | NCT04808505 |
Amicus Therapeutics (FOLD) operates in the Rare Disease sector. The current BTS Score is 57 (Grade: C).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The Phase 3 date for A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects A by Amicus Therapeutics (FOLD) is scheduled for July 1, 2027. This is the target date for the FDA to make a decision on this application.
A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects A is being developed by Amicus Therapeutics for the treatment of its target indication. It is currently in Phase 3 clinical trials.
If A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects A receives FDA approval, Amicus Therapeutics (FOLD) would be able to market the drug in the United States for its target indication. This typically leads to significant stock price movement for biotech companies. Investors should monitor the Phase 3 date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for FOLD on DilutionWatch at dilutionwatch.com/stock/FOLD.html.
You can view the full BiotechSign company profile for Amicus Therapeutics (FOLD) at biotechsign.com/app/company/FOLD, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.
This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSign is not a registered investment advisor.