PDUFARARE

RARE (Ultragenyx Pharmaceutical) FDA Decision: Ultragenyx Pharmaceutical (RARE)

Decision Date
September 19, 2026
16 days away

Drug Overview

Drug / TherapyRARE (Ultragenyx Pharmaceutical)
IndicationPDUFA date
Decision TypePDUFA
ConditionsPDUFA date
InterventionsRARE (Ultragenyx Pharmaceutical)

Company Overview

Ultragenyx Pharmaceutical (RARE) operates in the Rare Disease sector. The current BiotechSign Score is 47 (Grade: D).

Dilution Risk Assessment

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.

Frequently Asked Questions

Q:When is the PDUFA date for RARE (Ultragenyx Pharmaceutical)?

The PDUFA date for RARE (Ultragenyx Pharmaceutical) by Ultragenyx Pharmaceutical (RARE) is scheduled for September 19, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is RARE (Ultragenyx Pharmaceutical) used for?

RARE (Ultragenyx Pharmaceutical) is being developed by Ultragenyx Pharmaceutical for the treatment of PDUFA date. It is under FDA review.

Q:What happens if RARE (Ultragenyx Pharmaceutical) gets FDA approval?

If RARE (Ultragenyx Pharmaceutical) receives FDA approval, Ultragenyx Pharmaceutical (RARE) would be able to market the drug in the United States for PDUFA date. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.

Q:What is the dilution risk for RARE?

Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for RARE on DilutionWatch at dilutionwatch.com/stock/RARE.html.

Q:Where can I find more information about Ultragenyx Pharmaceutical?

You can view the full BiotechSign company profile for Ultragenyx Pharmaceutical (RARE) at biotechsign.com/app/company/RARE, which includes the BiotechSign Score, signal history, clinical trial data, and insider trading activity.

Disclaimer

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.

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