PDUFAARQT

roflumilast foam FDA Decision: Arcus Biosciences (ARQT)

Decision Date
October 5, 2026
79 days away

Drug Overview

Drug / Therapyroflumilast foam
Indicationseborrheic dermatitis
Decision TypePDUFA
Conditionsseborrheic dermatitis
Interventionsroflumilast foam

Company Overview

Arcus Biosciences (ARQT) operates in the Immuno-Oncology sector. The current BTS Score is 59 (Grade: C).

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 roflumilast foam?

The PDUFA date for roflumilast foam by Arcus Biosciences (ARQT) is scheduled for October 5, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is roflumilast foam used for?

roflumilast foam is being developed by Arcus Biosciences for the treatment of seborrheic dermatitis. It is under FDA review.

Q:What happens if roflumilast foam gets FDA approval?

If roflumilast foam receives FDA approval, Arcus Biosciences (ARQT) would be able to market the drug in the United States for seborrheic dermatitis. 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 ARQT?

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

Q:Where can I find more information about Arcus Biosciences?

You can view the full BiotechSign company profile for Arcus Biosciences (ARQT) at biotechsign.com/app/company/ARQT, which includes the BTS 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.