Key Takeaways from FDA Workshop on NMIBC

研报英文原文证据摘录

Key Takeaways from FDA Workshop on NMIBC

Equity Research

Industry Update — May 18, 2026

Biotechnology

Key Takeaways from FDA Workshop on

NMIBC

Our Call Yanan Zhu, PhD

We think today's FDA workshop could shape the regulatory path for high-grade papillary Equity Analyst | Wells Fargo Securities, LLC

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

NMIBC—2x the CIS-containing NMIBC market where a 2013 FDA workshop has led to a

Jeff Stithclear reg path and a burst of drug development activities (4 approvals to date).

Associate Equity Analyst | Wells Fargo Securities, LLC

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

FDA workshop on NMIBC. FDA held a workshop today discussing the similarities & Kuan-Hung Lin, PhD

differences between CIS & papillary only NMIBC as well as implications of the BCG Associate Equity Analyst | Wells Fargo Securities, LLC

shortage & BCG strain comparability. On CIS vs. papillary only, FDA noted that pts with Kuan-Hung.Lin@wellsfargo.com | 628-629-7566

CIS now have several treatment options whereas pts with papillary only disease are

under-served. On the BCG shortage, the workshop focused on how the shortage can be

addressed including finding alternatives such as gem-doce & other BCG strains.

Distinct molecular & clinical features. Presentations by two NMIBC KOLs indicate

that papillary & CIS NMIBC represent biologically & clinically unique disease states. Dr.

McConkey (U Rochester) highlighted a two-track model, w/ papillary disease driven

by FGFR3 mutations & CIS characterized by TP53 alterations & genomic instability.

Consistent w/ this, Dr. Lerner (Baylor) noted that EFS outcomes are generally more

favorable in papillary vs. CIS pts, suggesting a less aggressive clinical course.

Current treatment of BCG-UR papillary only patients. There were highly divergent