Urgent Meeting With FDA Requested to Address the Change in the Agency’s Unambiguous Guidance to Submit Supplemental BLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter May 13, 2025
Initial Data from Ph 3 Trial Demonstrating 75% CRR at 3 Months with nadofaragene firadenove) in BCG-unresponsive Japanese NMIBC Patients Announced April 30, 2025
Sasanlimab Combination Significantly Improves EFS in BCG-Naïve, High-Risk NMIBC, but misses OS endpoint April 30, 2025
FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN® (nadofaragene firadenovec-vncg) April 30, 2025
Positive Interim Results Demonstrating Durable Responses in Ongoing Ph 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC Announced April 30, 2025
TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC April 30, 2025
TAR-200 monotherapy demonstrates highest CRR reported to date with sustained clinical benefits in patients with certain types of bladder cancer April 30, 2025
Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec announced April 30, 2025
TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Ph 2b SunRISe-1 study (Cohort 2) in NMIBC patients April 22, 2025
Supplemental BLA submitted to FDA for use of ANKTIVA® plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease April 22, 2025
Relmada Therapeutics Licenses Ph 2 Bladder Cancer Candidate, NDV-01, from Trigone Pharma April 2, 2025
75.5% CR at any time in Ph 3 study of cretostimogene monotherapy for high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) April 2, 2025
Imfinzi approved in the US as perioperative immunotherapy for patients with muscle-invasive bladder cancer April 2, 2025
IMFINZI perioperative regimen improved EFS and OS across MIBC patients regardless of cPR status in post-hoc exploratory analysis of NIAGARA Ph 3 trial February 19, 2025
Data from Long-Term Follow-up Study to the OLYMPUS Trial that Shows a Median DOR of ~4 Years in Patients Achieving CR with JELMYTO Published in The Journal of Urology February 19, 2025
NDA initiated with US FDA for TAR-200 for patients with BCG-unresponsive high-risk NMIBC January 21, 2025
Sasanlimab in Combination with BCG Improves EFS in Patients with BCG-Naïve, High-Risk NMIBC January 15, 2025
Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive NMIBC December 10, 2024
Positive Results Announced from Ph 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC December 10, 2024
Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer December 10, 2024
FDA accepts NDA for UGN-102 (mitomycin) for intravesical solution for the treatment of LG-IR-NMIBC; PDUFA goal date: Jun 2025 October 22, 2024
Multiple Clinical Complete Responses Demonstrated Following Single Low Dose Administration of Bel-sar in Patients with NMIBC in Ongoing Ph 1 Trial October 22, 2024
