Kodiak reboots program following strong positive results in Phase 3

 

• Primary endpoint and all key secondary endpoints met with high statistical significance in GLOW study.
• With 6-month dosing of all patients, tarcocimab and the ABC platform continue to demonstrate differentiated durability.
• Following dialogue with US regulatory authorities, Kodiak plans to conduct one additional pivotal study with a commercial formulation of tarcocimab.
• New regulatory strategy could support a single Biologics License Application (BLA) for macular edema following retinal vein occlusion (RVO), wet age-related macular degeneration (wAMD) and non-proliferative diabetic retinopathy (NPDR).
• Kodiak believes that it has sufficient capital to fund a comprehensive KSI-501 clinical program in parallel.

https://www.prnewswire.com/news-releases/kodiak-reboots-tarcocimab-tedromer-development-program-following-strong-positive-results-in-phase-3-diabetic-retinopathy-glow-study-and-following-dialogue-with-us-regulatory-authorities-on-a-regulatory-pathway-for-bla-submission-301978149.html