Catching FDA catalysts

Biotech trades on binary events. A trial reads out, a regulator decides, and the stock gaps. The edge is knowing the dates before everyone else does and deciding your risk ahead of time, not in the chaos after the print. Here's the workflow.

1. Start in the Biotech view

Open the Biotech research view. It lays out the pipeline names with their upcoming catalysts: PDUFA dates, trial readouts, and panel meetings. Each event carries an impact score so you can tell a phase-3 readout in a lead indication from a minor protocol update.

Scan for the dates landing in your trading window and build a shortlist.

2. Track PDUFA dates and readouts

A PDUFA date is the deadline for a regulatory decision, and it's the cleanest catalyst on the calendar because the date is known well in advance. Trial readouts are fuzzier, often given as a quarter rather than a day, so treat the timing as a window and stay flexible.

Note which catalysts are make-or-break for the company versus incremental. A small-cap with one asset into a PDUFA is a different risk profile than a large name with a deep pipeline.

3. Set FDA & Biotech alerts

Add the shortlist to your Watchlist and put it in a group, then create an alert rule on that group with FDA & Biotech. Now approvals, complete response letters, PDUFA dates, clinical holds and designations on your names reach you as soon as SecBot processes them.

Leave the rule broad here, with no sentiment filter. In biotech even a modest headline can move a name, so you'd rather see them all than miss one. Add a second rule with Price Moves at a 10% minimum to catch the move itself.

4. Manage the event risk

This is the part most traders skip. Before a binary, decide your plan:

• Size the position for the gap, not the average day. These names can move 50% or more on a single print.
• Know whether you want to hold through the event or be flat into it. Both are valid; drifting in undecided is not.
• Watch for insiders or large holders adding ahead of a readout on the Institutional feed. It isn't a guarantee, but accumulation into a catalyst is worth noting.

TIP

Quiet hours skip every Telegram alert in the window, and skipped alerts aren't re-sent. If you're holding through a binary event, clear your quiet hours for those nights or turn on the Email Digest so nothing is lost.

After the event, the headline tells you the outcome but the follow-through tells you the trade. Watch how the stock holds its first-day move before assuming the gap is the whole story.

Next: Following the smart money.