Kodiak Sciences (NASDAQ: KOD) shares surged more than 62% in pre-market trading on September 28, 2026, after the company announced that its DAYBREAK Phase 3 pivotal trial met primary endpoints for both Zenkuda and KSI-501 in treating wet age-related macular degeneration.
What happened
Kodiak Sciences reported topline results from the DAYBREAK pivotal Phase 3 study on September 28, 2026. The trial evaluated Zenkuda and tabirafusp-ted in patients with wet age-related macular degeneration. Zenkuda met its primary endpoints, demonstrating strong immediacy and sustained clinical effect. A key highlight was that a majority of patients achieved a 24-week dosing interval using strict treat-to-dryness real-world retreatment criteria. KSI-501 also met primary endpoints as a bispecific conjugate targeting retinal diseases with inflammatory components. The company had announced on September 25 that these results would be presented on September 28, setting up the catalyst for the pre-market move.
Why the stock moved
The stock moved because the DAYBREAK trial results represent a major clinical milestone for Kodiak Sciences. According to Barrons, the stock popped 64% after the eye-disease drugs passed the key trial. The Phase 3 data suggests Zenkuda could become a new standard-of-care treatment for wet AMD, a condition affecting millions of patients worldwide. The 24-week dosing interval demonstrated in the trial is particularly significant because it could reduce the treatment burden on patients compared to existing therapies requiring more frequent injections. The company announced these results via PR Newswire on September 28, 2026, and had previewed the announcement date on September 25.
The numbers
KOD opened pre-market trading at $52.51, representing a 62.32% gain from the previous regular session close of $32.35. Volume during the pre-market session reached 2,330,122 shares, already nearly four times the average daily volume of approximately 597,322 shares based on short interest data. The company's market cap stands at approximately $2.78 billion. During regular trading on September 26, the stock had actually fallen 2.62%, making the overnight announcement the clear catalyst for the pre-market surge.
What to watch
Investors should monitor for detailed data presentations at upcoming scientific conferences and any regulatory guidance from the FDA regarding submission timelines for approval. The competitive landscape for wet AMD treatments includes established therapies from larger pharmaceutical companies, so Kodiak will need to demonstrate differentiation in safety and efficacy profiles. The company's cash position and runway to commercialization will also be important factors following this announcement. Watch for analyst revisions and any partnership announcements that could accelerate Zenkuda's path to market.