PDUFAARQT

roflumilast cream 0.15% FDA Decision: Arcus Biosciences (ARQT)

Decision Date
March 10, 2027
235 days away

Drug Overview

Drug / Therapyroflumilast cream 0.15%
Indicationplaque psoriasis sNDA
Decision TypePDUFA
Conditionsplaque psoriasis sNDA
Interventionsroflumilast cream 0.15%

Company Overview

Arcus Biosciences (ARQT) operates in the Immuno-Oncology sector. The current BTS Score is 44 (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 roflumilast cream 0.15%?

The PDUFA date for roflumilast cream 0.15% by Arcus Biosciences (ARQT) is scheduled for March 10, 2027. This is the target date for the FDA to make a decision on this application.

Q:What is roflumilast cream 0.15% used for?

roflumilast cream 0.15% is being developed by Arcus Biosciences for the treatment of plaque psoriasis sNDA. It is under FDA review.

Q:What happens if roflumilast cream 0.15% gets FDA approval?

If roflumilast cream 0.15% receives FDA approval, Arcus Biosciences (ARQT) would be able to market the drug in the United States for plaque psoriasis sNDA. 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.