Kodiak Sciences Faces Downgrade Following Failed GLEAM And GLIMMER Studies

Chardan Global Insights analyst Daniil Gataulin downgraded the Kodiak Sciences Inc KOD rating to Neutral from Buy.

On July 24, Kodiak announced topline results from three Phase 3 studies of tarcocimab tedromer, a novel antibody biopolymer conjugate, for neovascular age-related macular degeneration (AMD) and diabetic macular edema.

The GLEAM and GLIMMER studies of tarcocimab tedromer enrolled 460 and 457 treatment-naïve subjects with DME, respectively. The DAYLIGHT study evaluated the efficacy and safety of a high-intensity dosing regimen of tarcocimab tedromer in 557 treatment-naïve subjects with wet AMD. 

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While DAYLIGHT met the primary endpoint of non-inferiority in visual acuity gains for monthly dosing of '301 vs. aflibercept (dosed every 8 weeks after three loading doses), GLEAM and GLIMMER studies did not meet their primary endpoint of non-inferiority in visual acuity gains in the '301 arm (dosed 8-24 wks after three monthly loading doses) vs. aflibercept (dosed every 8 wks after 5 monthly loading doses), notes the analyst.

Given that GLEAM and GLIMMER studies were the basis for the company's regulatory and clinical development strategy, Kodiak has decided to discontinue KSI-301 development.

Based on these results and the discontinuation of the KSI-301 program, the analyst downgraded KOD shares to Neutral and withdrew the price target. 

Price Action: KOD shares are trading lower by 5.07% to $3.74 on the last check Tuesday.