Key Points
Shares of Kodiak Sciences (NASDAQ: KOD) soared 178% on Monday after the eye medicine developer announced positive clinical trial results for two of its leading investigational drug candidates.
Promising results
Kodiak said Zenkuda and KSI-501 met their primary endpoints in a Phase 3 clinical study in patients with wet age-related macular degeneration, a serious eye condition in which abnormal blood vessels grow beneath the retina and leak fluid, which can lead to rapid vision loss.
Zenkuda’s results were particularly encouraging, with rapid and long-lasting therapeutic effects and a favorable safety profile.
Chief medical officer J. Pablo Velazquez-Martin said the study demonstrated the attributes Kodiak designed Zenkuda to achieve, including “rapid disease control in wet AMD and the potential for six-month durability under stringent treat-to-dryness retreatment criteria.”
Regulatory approval could pave the way to commercialization
Based on these results, Kodiak intends to file a Biologics License Application (BLA) for Zenkuda later this year. A BLA is a formal request submitted to the U.S. Food and Drug Administration (FDA) to market a biological product across state lines.
CEO Victor Perlroth said the data positions the biotech “for the next stage of Kodiak’s evolution, as we prepare for the planned commercialization of Zenkuda as a potential best-in-class therapy.”
It’s a potentially lucrative market. Global sales of retinal drugs are projected to exceed $32 billion by 2030, according to Strategic Market Research.
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Joe Tenebruso has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.