Question 1

What is a PDUFA date?

Accepted Answer

A PDUFA (Prescription Drug User Fee Act) date is the FDA's deadline to make a decision on a drug application. The FDA sets this date when it accepts a New Drug Application (NDA) or Biologics License Application (BLA) for review. PDUFA dates are among the most impactful binary events in biotech — stocks can move 50%+ in either direction.

Question 2

What are the clinical trial phases?

Accepted Answer

Phase 1 tests safety in a small group. Phase 2 tests efficacy and dosing in a larger group. Phase 3 is a large-scale confirmatory trial that, if successful, supports regulatory filing. Each phase has a data readout that can significantly move a stock's price. We primarily track Phase 2 and Phase 3 readouts as catalysts.

Question 3

How are catalyst dates determined?

Accepted Answer

We source catalyst dates from ClinicalTrials.gov trial completion estimates, FDA PDUFA calendars, company press releases, and earnings call guidance. Dates marked as exact have a specific date; others show quarter (Q1, Q2) or half (H1, H2) when precision is limited.

Question 4

What happens when a catalyst outcome is positive or negative?

Accepted Answer

Positive outcomes (trial met endpoints, FDA approval) typically drive sharp price increases, especially in small-cap biotech. Negative outcomes (missed endpoints, complete response letter) can cause 50-80% drops. We track outcomes and label them so you can see which catalysts have already resolved.

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