| Drug / Therapy | pegunigalsidase alfa |
| Indication | Fabry disease pediatric |
| Decision Type | PDUFA |
| Conditions | Fabry disease pediatric |
| Interventions | pegunigalsidase alfa |
Amicus Therapeutics (FOLD) operates in the Rare Disease sector. The current BTS Score is 62 (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 PDUFA date for pegunigalsidase alfa by Amicus Therapeutics (FOLD) is scheduled for September 22, 2026. This is the target date for the FDA to make a decision on this application.
pegunigalsidase alfa is being developed by Amicus Therapeutics for the treatment of Fabry disease pediatric. It is under FDA review.
If pegunigalsidase alfa receives FDA approval, Amicus Therapeutics (FOLD) would be able to market the drug in the United States for Fabry disease pediatric. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA 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 BiotechSigns 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. BiotechSigns is not a registered investment advisor.