Submission of a Rolling NDA to the FDA for UGN-102 initiated
“The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and CEO, UroGen. “We look forward to working closely with the FDA throughout the review process and remain steadfast in our commitment to address unmet medical needs in the uro-oncology space and advance patient care.”
Share:
More News
CEO Snehal Patel commented, “We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a
“At Ferring, we are committed to meeting the unmet needs in bladder cancer care and equipping uro-oncologists with critical evidence they need to deliver effective, and life-changing treatment,” said Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals. “These new
“We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products,” said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. “Both drug targets are well-characterised drivers of many cancers, and we are excited to be
“We do not view today’s unsatisfactory outcome as a failure of Globo H,” Dr. Heidi Wang, CEO of OBI Pharma added. “There may come a time, with a deeper scientific understanding of the Globo H function, it may play a meaningful role once again.”
