Sellas Will Take Increasingly Good Results With NeuVax Into FDA Discussions
Executive Summary
Preparing to meet with FDA in December to plan next steps for NeuVax in triple-negative breast cancer, Sellas reveals 26-month data that show further clinical benefit compared with a 19-month interim look. Firm still hopes to out-license the vaccine candidate.
You may also be interested in...
Phase II Study Opens Window For Sellas' NeuVax In Triple-Negative Breast Cancer
Sellas is pursuing accelerated approval for NeuVax in triple-negative breast cancer based on Phase II data, but that may be a tough sell with the FDA.
Galena Left To Hope Review Of Trial Operations Rescues NeuVax
Cancer vaccine development is a tricky undertaking, but Galena may be grasping at last straws with a third-party review of a recently halted study of NeuVax, hoping to discover operational reasons for cancer vaccine's poor performance.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.