What Is a PDUFA Date? The Date That Moves Biotech Stocks

You see a biotech stock jump 40% on a headline that says “FDA approves drug ahead of PDUFA date.” You don’t know what a PDUFA date is, why it moved the stock, or whether the move already happened. So you buy after the pop and ride it back down.

A PDUFA date is the deadline the FDA gives itself to approve or reject a drug application. It is the single most predictable binary catalyst in biotech. The trade is made in the weeks before the date, not the day of.

What PDUFA actually is

PDUFA stands for Prescription Drug User Fee Act. In 1992, Congress let the FDA collect user fees from drug sponsors in exchange for binding review deadlines. Companies pay fees; the FDA commits to finishing review within 6 months for priority review or 10 months for standard review. The date the FDA must act by is the PDUFA date.

The program reauthorizes every five years. The current cycle, PDUFA VII, runs through fiscal year 2027. The full performance goals are published on the FDA user-fee programs page.

PDUFA dates apply to four application types: NDA (new drug application), BLA (biologics license application), sNDA (supplemental new drug application, for a new use of an approved drug), and sBLA (supplemental biologics license application).

Step 1: Find the PDUFA date

Three sources, in order of usefulness:

1. BioPharmCatalyst.com. The free PDUFA calendar lists dates by company, drug, and indication. Start here.
2. The company’s press release announcing FDA acceptance. The FDA sends an acceptance letter with the PDUFA goal date; companies disclose it within days. Search “[ticker] PDUFA date” or check the company’s investor relations page.
3. Our FDA calendar, which tracks confirmed dates across the biotech sector.

Example: Replimune (REPL) announced on June 11, 2026 that the FDA accepted its third BLA resubmission for RP1 in advanced melanoma and set a PDUFA date of August 2, 2026. The press release also disclosed an advisory committee meeting in late July. Anyone reading that release on June 11 had seven weeks to position before the decision.

Step 2: Check the review type

Priority review means a 6-month clock and signals the FDA sees a meaningful advance over existing therapy. Standard review means 10 months. Priority review does not mean approval is more likely; it means the FDA agreed to move faster. Look for “Priority Review” or “Standard Review” in the same press release that announces the PDUFA date.

Example: Ultragenyx (RARE) received priority review for UX111, its AAV gene therapy for Sanfilippo syndrome type A, with a PDUFA date of September 19, 2026. The priority designation reflects that there are no approved treatments for the disease. It does not guarantee approval.

Step 3: Watch for the AdCom

An AdCom (advisory committee meeting) is a panel of outside experts that votes on whether to recommend approval. AdComs usually happen 4 to 8 weeks before the PDUFA date and are non-binding. The FDA follows the AdCom vote the large majority of the time, but a negative vote is a strong predictor of a Complete Response Letter.

When an AdCom is scheduled, mark both dates. The AdCom is often where the real move happens, because the vote removes uncertainty. Replimune’s RP1 AdCom is set for late July, ahead of the August 2 PDUFA. If the panel votes yes, the stock runs into the PDUFA; if it votes no, the stock drops hard and the PDUFA becomes a formality.

Step 4: Understand the three outcomes

On or before the PDUFA date, the FDA does one of three things:

1. Approval. The stock typically gaps up 20 to 80% on approval, sometimes more for small caps with no approved drugs. See our Madrigal resmetirom MASH approval write-up for a clean example of how an approval-day move plays out.
2. Complete Response Letter (CRL). The FDA says “not yet.” The stock typically drops 30 to 60% on the day. A CRL is not the end of the company, but it is the end of that trade. We cover what a CRL does to a stock in our Complete Response Letter guide.
3. Extension. The FDA pushes the PDUFA date, usually by 3 months, to review new data the company submitted or because the agency needs more time. The stock usually drops 10 to 20% on the delay announcement, not 50%. A delay is not a CRL.

Step 5: Position before the run-up, not on the decision

Most of the move happens in the 2 to 6 weeks before the PDUFA date, not on the day. Traders who buy the run-up and sell into the approval pop capture the move; traders who wait for the approval headline buy the top.

The pattern repeats: a $5 small-cap biotech with a PDUFA in 30 days often runs to $8 or $9 on speculation, then gaps to $12 on approval and fades to $7 within a week as the speculators exit. Buying at $12 is the common mistake. The Vertex suzetrigine pain PDUFA case is a good reference for how a real approval-day move looks after a run-up.

Step 6: Size for binary risk

A single pre-PDUFA position should not exceed 2 to 5% of a portfolio. Biotech PDUFA dates are binary: the stock goes up 30 to 50% on approval or drops 30 to 60% on a CRL. One CRL can wipe out a year of gains if the position is too large. If you cannot stomach a 50% loss on the position, the position is too big for a pre-PDUFA trade.

Common mistakes

• Buying the day before the PDUFA. You are betting on a coin flip and paying the run-up premium. The edge is in the run-up, not the decision.
• Treating an extension as a CRL. A 3-month extension is the FDA asking for more time. Selling into an extension at a 40% loss turns a delay into a permanent loss.
• Ignoring the AdCom. A negative AdCom vote roughly doubles the probability of a CRL. If you own the stock and the panel votes no, that is your exit signal, not the PDUFA date.
• Falling for “priority review means safe approval.” Priority review is about speed, not probability. Drugs get CRLs on priority review all the time.
• Not reading the actual trial data. The PDUFA is the date; the data is the reason. If you cannot read the trial, you are gambling, not investing. Our guide to reading a clinical trial press release walks through the numbers that actually predict an approval.

Final checklist

• PDUFA date confirmed from company press release or BioPharmCatalyst
• Review type (priority or standard) noted
• AdCom date on the calendar if scheduled
• Position sized to 2 to 5% of portfolio
• Exit plan for approval, CRL, and extension written down before the date
• Not buying the day before the PDUFA