SURGE Therapeutics Raises $32M Series B Financing to Advance Intraoperative Immunotherapy to Improve Cancer Patient Survival Outcomes Post-Surgery February 25, 2026
European Commission grants conditional marketing authorization for ANKTIVA + BCG in BCG-unresponsive NMIBC CIS, with or without papillary tumors February 25, 2026
Positive Ph 2 Data for Maveropepimut (MVP-S) + Pembrolizumab and Low-Dose Cyclophosphamide in Metastatic Bladder Cancer Reported February 1, 2026
Updated Interim Data from Ph 2 ADVANCED-2 Trial of TARA-002 in BCG-Unresponsive NMIBC Patients to be Presented January 25, 2026
Regulatory Discussions with FDA on Potential Resubmission Path for ANKTIVA® in BCG-Unresponsive Papillary Bladder Cancer Advanced January 25, 2026
FDA Alignment Received on Registrational Studies Design for NDV-01 for 2L refractory high-grade NMIBC and in intermediate-risk NMIBC in the adjuvant setting January 18, 2026
ANKTIVA® with BCG Demonstrates 96% Survival at Three Years with Median Survival Not Yet Reached in BCG-Unresponsive High-Grade Papillary-Only NMIBC December 22, 2025
PADCEV + Keytruda combo Significantly Improves Survival for MIBC Patients Regardless of Cisplatin Eligibility December 22, 2025
Conditional Marketing Authorization Recommendation from EMA Received for ANKTIVA® with BCG for NMIBC Carcinoma in Situ December 15, 2025
enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness December 9, 2025
Updated Interim Data from Ph 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients Announced December 9, 2025
MVR-T3011 Latest Clinical Results in BCG-Unresponsive NMIBC Patients Demonstrate High Response December 9, 2025
INLEXZO™ (gemcitabine intravesical system) delivers 74% DFS at one year in BCG-unresponsive, high-risk, papillary-only NMIBC December 9, 2025
FDA Approves KEYTRUDA® and KEYTRUDA QLEX™ (berahyaluronidase alfa-pmph formulation), Each with Padcev®, as Perioperative Treatment for Adults with Cisplatin-Ineligible MIBC November 24, 2025
77.8% Three-Month Complete Response Rate Reported from Ph 3 UTOPIA Trial of UGN-103; FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Received November 10, 2025
Development of UGN-301 (zalifrelimab) to discontinue following completion of Ph 1 dose escalation study November 10, 2025
FDA alignment secured on planned Ph 3 NDV-01 program in 2L BCG-unresponsive NMIBC patients and Intermediate risk NMIBC in the adjuvant setting November 10, 2025
FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX™, Each in Combination with Padcev, for Cisplatin-ineligible Patients with MIBC October 29, 2025
ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent LG-IR NMIBC October 7, 2025
