PDUFAPTGX

setanaxib FDA Decision: Protagonist Therapeutics (PTGX)

Decision Date
September 12, 2026
56 days away

Drug Overview

Drug / Therapysetanaxib
Indicationidiopathic pulmonary fibrosis
Decision TypePDUFA
Conditionsidiopathic pulmonary fibrosis
Interventionssetanaxib

Company Overview

Protagonist Therapeutics (PTGX) operates in the Peptide Therapeutics sector. The current BTS Score is 52 (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 setanaxib?

The PDUFA date for setanaxib by Protagonist Therapeutics (PTGX) is scheduled for September 12, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is setanaxib used for?

setanaxib is being developed by Protagonist Therapeutics for the treatment of idiopathic pulmonary fibrosis. It is under FDA review.

Q:What happens if setanaxib gets FDA approval?

If setanaxib receives FDA approval, Protagonist Therapeutics (PTGX) would be able to market the drug in the United States for idiopathic pulmonary fibrosis. 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 PTGX?

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

Q:Where can I find more information about Protagonist Therapeutics?

You can view the full BiotechSign company profile for Protagonist Therapeutics (PTGX) at biotechsign.com/app/company/PTGX, 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.