Free tool
2026 PDUFA Calendar: 6 FDA Decision Dates + AI Analysis
Every 2026 FDA approval decision, with AI-generated plain-English summaries and an investor significance score. Free, updated daily.
What is a PDUFA date?
A PDUFA date — short for Prescription Drug User Fee Act date — is the calendar deadline by which the FDA has committed to making an approval decision on a new drug application. It is the single most important kind of biotech catalyst because it delivers a binary, calendar-known outcome: the FDA either approves the drug, or it issues a Complete Response Letter (CRL) explaining why it cannot.
The PDUFA framework exists because, before it became law in 1992, the FDA had no statutory deadline to review drug applications. Companies could wait years with no clarity. Today, drug sponsors pay a user fee (currently around $4 million per submission) and, in exchange, the FDA commits to a 10-month review for standard New Drug Applications (NDAs) and Biologics License Applications (BLAs), or a 6-month review under Priority Review.
For investors, PDUFA dates matter because they collapse uncertainty into a single moment. A small-cap biotech with one drug in late-stage development might move 30-60% in either direction on its PDUFA day. Even large pharmas can see meaningful 5-15% moves on high-profile decisions. Approvals often arrive a few days or weeks before the listed PDUFA date — early action is historically a mildly bullish signal — while Complete Response Letters typically land on, or shortly before, the deadline itself.
The PDUFA action date is announced by the company shortly after the FDA accepts the filing, usually disclosed in a press release or 8-K. From there, the path to the decision can include FDA information requests, an Advisory Committee (AdCom) vote, and a final labeling negotiation. Each of these can shift the probability of approval, and each of these is what we track and translate, in plain English, on the calendar below.
Want to learn more first? Read our deep-dive guide: What Is a PDUFA Date? A Complete Guide for Biotech Investors.
Upcoming 2026 FDA decisions
2026-06-25
PDUFA decision for TransCon hGH label expansion in adult GHD
Skytrofa (lonapegsomatropin) · Adult growth hormone deficiency
Ascendis seeks adult GHD approval for its weekly growth hormone Skytrofa. Approval triples the addressable market beyond pediatric GHD and adds defensive franchise breadth as competition intensifies.
Approval highly likely given supportive Phase 3. Stock impact modest single-day; meaningful for full franchise trajectory.
2026-07-02
PDUFA decision for brensocatib in bronchiectasis
Brensocatib · Non-cystic fibrosis bronchiectasis
Insmed's DPP1 inhibitor brensocatib is up for FDA approval in non-CF bronchiectasis — a chronic lung condition with no approved therapy and 350,000+ US patients. Approval transforms Insmed from a single-product Arikayce company into a multi-billion dollar respiratory franchise.
Phase 3 ASPEN met its primary endpoint with statistically significant reduction in pulmonary exacerbations. Approval probability is very high. Stock likely up 15-25% on approval, down 35-50% on CRL. The post-approval launch trajectory is the multi-year story.
2026-07-07
PDUFA decision for volixibat in PFIC
Volixibat · Progressive familial intrahepatic cholestasis (PFIC)
Mirum extends its rare cholestatic liver disease franchise with volixibat in PFIC. Approval gives Mirum a second commercial asset alongside Livmarli and a durable revenue base in pediatric rare liver disease.
Approval likely. Stock impact moderate single-day; meaningful for franchise breadth and post-Livmarli growth narrative.
2026-07-14
PDUFA decision for trofinetide label expansion in adult Rett syndrome
Daybue (trofinetide) · Adult Rett syndrome
Acadia seeks adult Rett syndrome approval to extend Daybue beyond its current pediatric label. Adult approval expands Daybue's TAM and helps offset the post-Nuplazid generic erosion.
Approval probability moderate. Phase 3 LILAC-2 data was supportive. A clean approval extends the Daybue franchise meaningfully.
2026-07-17
PDUFA decision for UX111 in MPS IIIA (Sanfilippo A)
UX111 (AAV9 SGSH gene therapy) · MPS IIIA / Sanfilippo syndrome type A
Ultragenyx seeks accelerated approval for UX111, an AAV gene therapy for a fatal pediatric lysosomal storage disease with no approved treatment. Approval would be the first-ever therapy for Sanfilippo A and a major credibility win for Ultragenyx's gene therapy platform.
Approval is by no means guaranteed; FDA has been skeptical of small datasets in pediatric AAV programs post-Elevidys. Approval up 30-50%; CRL down 25-40%. Probability ~50/50.
2026-07-24
PDUFA decision for sparsentan label expansion in FSGS
Filspari (sparsentan) · Focal segmental glomerulosclerosis (FSGS)
Travere seeks full FSGS approval for Filspari. The drug already has full IgA nephropathy approval; FSGS approval roughly doubles the franchise opportunity and adds a defensive moat against incoming kidney disease entrants.
Approval probability is ~60%. Phase 3 DUPLEX data on the proteinuria endpoint was supportive but the kidney function endpoint was less clear. CRL likely costs 25-35% on TVTX.
Browse by month
January 2026
Coming soon
February 2026
Coming soon
March 2026
Coming soon
April 2026
View →
May 2026
View →
June 2026
View →
July 2026
View →
August 2026
Coming soon
September 2026
Coming soon
October 2026
Coming soon
November 2026
Coming soon
December 2026
Coming soon
How this is different from raw PDUFA calendars
Free PDUFA calendars on BioPharmCatalyst, BPIQ, RTT News, and the FDA itself give you a list of dates, tickers, and indications. That is useful — and limited. ClinicalInvestor adds the analysis layer those sites leave out.
Raw calendar sites
- List of PDUFA dates and tickers
- Drug name and indication
- Maybe links to FDA filings
- You translate the science yourself
ClinicalInvestor
- Everything raw calendars give you, plus:
- AI-generated plain-English investor summary for every event
- What to expect (probability, asymmetric outcomes, stock-move ranges)
- Significance score: must-watch / important / notable
- Historical context vs. precedent FDA decisions
- Direct links to company profile, pipeline, and bull/bear case
- Free Trial Translator for any underlying ClinicalTrials.gov ID
Frequently asked questions
What is a PDUFA date?+
A PDUFA (Prescription Drug User Fee Act) date is the calendar deadline by which the FDA has committed to making an approval decision on a new drug application. The outcome is binary — the FDA either approves the drug or issues a Complete Response Letter (CRL) explaining why it was not approved. Standard PDUFA dates are 10 months after submission; Priority Review PDUFA dates are 6 months.
How are 2026 PDUFA dates assigned?+
When a company submits an NDA (New Drug Application) or BLA (Biologics License Application), the FDA performs a 60-day filing review. Once accepted, the FDA assigns a PDUFA action date 10 months out (or 6 months for Priority Review). Companies disclose this date in an 8-K filing or press release.
How accurate is the FDA at hitting PDUFA dates?+
The FDA hits its PDUFA deadline more than 90% of the time. Approvals often arrive days or weeks early, while Complete Response Letters (CRLs) typically come on or just before the PDUFA date. Early action on a drug is a mildly bullish signal historically.
Why do biotech stocks move so much on PDUFA dates?+
A PDUFA decision resolves uncertainty about a drug’s commercial future in a single moment. Small-cap biotechs commonly move 30-60% on PDUFA day; large diversified pharmas move 5-15%. Information asymmetry collapses, options unwind, and short-covering or stop-loss cascades amplify the move.
Is the ClinicalInvestor PDUFA calendar free?+
Yes. The full 2026 PDUFA calendar, including every FDA decision, drug, indication, and AI-generated investor summary, is free. Premium ($19/month) adds real-time alerts, the advanced biotech screener, and unlimited use of the Trial Translator tool.
How is this different from BioPharmCatalyst, BPIQ, or RTT News?+
Other PDUFA calendars list dates, tickers, and indications. ClinicalInvestor adds an AI-generated plain-English investor summary, an explicit significance score (must-watch / important / notable), what to expect from the readout, historical context, and direct links to company profiles and trial analysis. It is built for retail investors who want context, not just a list of dates.
How do I trade biotech stocks around PDUFA dates?+
Common approaches include the catalyst run-up trade (buy 3-6 weeks before, sell shortly before the date), the hold-through approach (own shares through the binary outcome), and the options straddle (profit from any large move). Read our guide on PDUFA dates explained for the strategy details, and never risk more than you can afford to lose on a single binary FDA event.
Get the week’s biggest FDA decisions in your inbox
Free Sunday briefing: every PDUFA date, Phase 3 readout, and AdCom in the week ahead.
Subscribe free →