FDA PDUFA Deep Dive—Analysis of Timing, Outcomes, and Drivers from 2021 to Present

Research evidence excerpt

FDA PDUFA Deep Dive—Analysis of Timing, Outcomes, and Drivers from 2021 to Present

Equity Research

Industry Update — June 9, 2026

Biotechnology

FDA PDUFA Deep Dive—Analysis of Timing,

Outcomes, and Drivers from 2021 to Present

Our Call Yanan Zhu, PhD

We analyzed 752 PDUFA events (late 2021–mid-May 2026) to assess timing, outcome, Equity Analyst | Wells Fargo Securities, LLC

Yanan.Zhu@wellsfargo.com | 415-396-3194

and other attributes. We highlight potentially actionable insights such as correlation

Jeff Stithbetween outcome and timing of FDA decision relative to PDUFA target date.

Associate Equity Analyst | Wells Fargo Securities, LLC

Jeff.Stith@wellsfargo.com | 631-790-7157

FDA PDUFA analysis. We analyzed 752 FDA PDUFA events that occurred between late Kuan-Hung Lin, PhD

2021 and mid-May 2026, including 685 approvals and 67 CRLs (approval rate 91%). We Associate Equity Analyst | Wells Fargo Securities, LLC

performed 12 analyses to assess implication of various event attributes on outcomes, Kuan-Hung.Lin@wellsfargo.com | 628-629-7566

including decision timing relative to PDUFA (early, on time, late), review type (priority/

standard; with/without extension), filing type, prior CRL/AdComm, disease groups, and

modalities, etc. We also assessed approval rates by year.

Timing is important—missing the PDUFA raises risk. In our analysis, decisions

announced after the PDUFA target date had a much lower chance of approval (65.3%)

compared with on-time decisions (90.5%), whereas decisions that came in early had

the highest chance for approval (96.4%). Analyzed another way, approvals rarely come

after PDUFA (11.2%), whereas CRLs often arrive after PDUFA (52.1%). While delayed

announcement could play a role, the conclusion remains that missing PDUFA raises risk.