PDUFAPRAX

PRAX-114 FDA Decision: Praxis Precision Medicine (PRAX)

Decision Date
May 18, 2026
17 days ago

Drug Overview

Drug / TherapyPRAX-114
Indicationmajor depressive disorder
Decision TypePDUFA
Conditionsmajor depressive disorder
InterventionsPRAX-114

Company Overview

Praxis Precision Medicine (PRAX) operates in the Neuroscience sector. The current BTS Score is 46 (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 PRAX-114?

The PDUFA date for PRAX-114 by Praxis Precision Medicine (PRAX) is scheduled for May 18, 2026. This is the target date for the FDA to make a decision on this application.

Q:What is PRAX-114 used for?

PRAX-114 is being developed by Praxis Precision Medicine for the treatment of major depressive disorder. It is under FDA review.

Q:What happens if PRAX-114 gets FDA approval?

If PRAX-114 receives FDA approval, Praxis Precision Medicine (PRAX) would be able to market the drug in the United States for major depressive disorder. 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 PRAX?

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

Q:Where can I find more information about Praxis Precision Medicine?

You can view the full BiotechSigns company profile for Praxis Precision Medicine (PRAX) at biotechsign.com/app/company/PRAX, 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.