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Catalyst Types

Browse biotech catalysts by type. Currently tracking 1876 upcoming events.

Biotech Earnings Reports

Quarterly reports where biotech and pharma companies disclose financials, cash runway and — critically — pipeline and regulatory updates.

Phase 2 Clinical Trials

Mid-stage trials that test whether a drug actually works (efficacy) and at what dose, in a few dozen to a few hundred patients.

Phase 3 Clinical Trials

Pivotal, large-scale trials that confirm a drug’s efficacy and safety. Positive Phase 3 data is usually the gateway to FDA submission.

FDA target action dates — the deadline by which the FDA must decide on a drug application. The single most-watched binary catalyst in biotech.

The formal application asking the FDA to approve a new small-molecule drug — the milestone that starts the review clock toward a PDUFA date.

The application to approve a biologic — antibodies, vaccines, cell and gene therapies — that opens the FDA review toward a PDUFA date.

Medical Conference Presentations

Data presentations at major medical congresses (ASCO, AHA, AAN and more) where detailed trial results are unveiled to the scientific community.

Phase 1 Clinical Trials

First-in-human trials focused on safety, dosing and tolerability — the earliest clinical catalyst, in a small group of volunteers or patients.

FDA Advisory Committee Meetings

Public meetings where independent experts review a drug application and vote on its benefit–risk — a high-drama catalyst that usually foreshadows the FDA decision.

Journal Publications

Peer-reviewed publication of trial results in journals such as NEJM or The Lancet — the definitive, fully-vetted dataset behind a catalyst.

Understanding Biotech Catalyst Types

Biotech catalysts are key events that can significantly impact a company's stock price. CatalystAlert tracks multiple types of catalysts to help investors stay informed about upcoming opportunities and risks in the biotechnology sector.

PDUFA Dates

PDUFA (Prescription Drug User Fee Act) dates are FDA target action dates for drug approval decisions. These are among the most important catalysts for biotech investors as they represent binary events with significant stock price implications.

Clinical Trial Results

Phase 1, 2, and 3 clinical trial results provide critical data on drug safety and efficacy. Phase 3 readouts are particularly significant as they often determine whether a drug will be submitted for FDA approval.

FDA Advisory Committee (AdCom) Meetings

AdCom meetings bring together external experts to review drug applications and provide recommendations to the FDA. While not binding, AdCom votes are often followed by the FDA and can signal approval or rejection.