PDUFASNDX

entinostat + exemestane FDA Decision: Syndax Pharmaceuticals (SNDX)

Decision Date
October 8, 2026
126 days away

Drug Overview

Drug / Therapyentinostat + exemestane
IndicationHR+ HER2- breast cancer
Decision TypePDUFA
ConditionsHR+ HER2- breast cancer
Interventionsentinostat + exemestane

Company Overview

Syndax Pharmaceuticals (SNDX) operates in the Oncology sector. The current BTS Score is 63 (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 entinostat + exemestane?

The PDUFA date for entinostat + exemestane by Syndax Pharmaceuticals (SNDX) is scheduled for October 8, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is entinostat + exemestane used for?

entinostat + exemestane is being developed by Syndax Pharmaceuticals for the treatment of HR+ HER2- breast cancer. It is under FDA review.

Q:What happens if entinostat + exemestane gets FDA approval?

If entinostat + exemestane receives FDA approval, Syndax Pharmaceuticals (SNDX) would be able to market the drug in the United States for HR+ HER2- breast cancer. 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 SNDX?

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

Q:Where can I find more information about Syndax Pharmaceuticals?

You can view the full BiotechSigns company profile for Syndax Pharmaceuticals (SNDX) at biotechsign.com/app/company/SNDX, 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. BiotechSigns is not a registered investment advisor.