How to Track PDUFA Dates: A Biotech Trader’s Guide

For biotech traders, PDUFA dates are the calendar that matters most. A PDUFA date is the FDA’s target action date for deciding on a drug application, and it is one of the highest-variance catalysts in the market. This guide explains how to find, track and stay ahead of these FDA decision dates.

Where PDUFA dates come from

PDUFA dates are not published in a single official government feed. Companies typically disclose them in press releases and SEC filings when the FDA accepts an application for review. That means tracking them well requires piecing together several sources:

• Company press releases and 8-K filings — the primary source, announced when the FDA sets the date.
• SEC EDGAR — full-text search of filings can surface acceptance and date disclosures.
• FDA advisory committee calendars — AdComm meetings often precede a decision and hint at timing.
• Catalyst calendar tools — aggregators that collect and standardise these dates in one place.

What to record for each date

A date alone is not enough. For each upcoming decision, capture:

• The ticker and drug, and whether it is an NDA or BLA.
• The indication and whether the pivotal trial was clearly positive.
• Any advisory committee meeting and its vote.
• The company’s cash runway — a cash-strapped company may raise capital around the event, adding dilution risk.
• What outcome the market appears to be pricing in.

Free vs paid tracking

You can track PDUFA dates manually by monitoring filings and press releases, but it is time-consuming and easy to miss disclosures. Catalyst tools save time by aggregating dates, and the better ones add context such as approval-probability estimates and cash-runway analysis. See our comparison of biotech catalyst tools for the trade-offs.

BioRadar publishes an upcoming FDA decisions page and a PDUFA calendar for free, each with a Probability-of-Approval score, so you can see what is coming without piecing it together yourself.

Don’t just track the date — track the setup

Historically, biotech stocks tend to run up before a PDUFA date and give some of it back afterwards. Our data on how biotech stocks move around FDA decisions shows the average pre-event run-up was more reliable than the decision-day move itself. Tracking the date is step one; understanding the run-up window and the risk of a Complete Response Letter is what turns a calendar into an edge.

A simple tracking workflow

1. Build a watchlist of tickers with upcoming decisions.
2. For each, note the date, drug, indication and application type.
3. Check cash runway and recent financing activity.
4. Set an alert two to four weeks before the date to reassess.
5. Decide your plan for both outcomes before the event, not during it.

Frequently asked questions

Where can I find upcoming PDUFA dates for free?

Company press releases and SEC filings are the primary free sources, but they are scattered. Some catalyst tools publish upcoming FDA decision dates publicly — BioRadar’s upcoming FDA decisions page and PDUFA calendar are free and include an approval-probability score for each date.

Is there an official FDA list of PDUFA dates?

No single official feed lists all PDUFA dates. The FDA does not publish a comprehensive upcoming-decision calendar; dates are disclosed by companies when the FDA accepts an application. Advisory committee meeting schedules are published and can indicate that a decision is approaching.

How far in advance are PDUFA dates known?

Usually several months. When the FDA accepts an application for review it assigns a target action date — typically around ten months out for a standard review or six months for a priority review — which the company then discloses.