Kodiak Sciences Shares More Than Double as Wet AMD Drug Zenkuda Meets Primary Goal in Phase 3 DAYBREAK Trial

PALO ALTO, Calif. — Shares of Kodiak Sciences more than doubled on Monday after the retina-focused biotechnology company said two experimental treatments for wet age-related macular degeneration met the main goal of a pivotal Phase 3 trial. The stock rose 143.34%, or $46.37, to $78.72 as of 10 a.m. Eastern time, from a prior close of about $32.35.

Kodiak announced the results of the DAYBREAK study before the market opened. The company said the primary endpoints were met for both Zenkuda, also known as tarcocimab tedromer, and tabirafusp-ted, known as KSI-501, with both demonstrating non-inferiority in vision gains compared with aflibercept, sold as Eylea, at one year. The move started before the open: Investing.com reported the shares were up 31.9% in pre-open trading after the release, and they had already climbed into the $50s in earlier premarket trading ahead of the data, according to Timothy Sykes' market news site.

Wet AMD is a leading cause of vision loss, according to GuruFocus, and is treated with anti-VEGF drugs such as aflibercept. Kodiak said Zenkuda showed strong immediacy of effect, matching or exceeding aflibercept through the loading phase, and strong durability, with 54% of patients achieving six-month durability at year one while the company used strict treat-to-dryness retreatment criteria. Kodiak described that as a "potential new standard-of-care profile." Safety was favorable, the company said, with a 0% intraocular inflammation rate and a 0.5% rate of cataract adverse events, compared with 0.9% for the aflibercept comparator.

The second candidate, tabirafusp-ted, is a bispecific antibody that blocks both IL-6 and VEGF. It met its visual acuity primary endpoint with a p-value of 0.0036 and a key anatomical secondary endpoint with a p-value below 0.0001, according to figures from the company's press release cited by TOPONE Markets. Kodiak said both drugs demonstrated safety consistent with the established profile of aflibercept.

DAYBREAK is a non-inferiority study, meaning it was designed to show the new drugs perform no worse than the existing standard rather than better. Patients randomized to Zenkuda received individualized dosing every four to 24 weeks as needed after four monthly loading doses. Patients randomized to KSI-501 received fixed dosing every eight weeks, with additional as-needed dosing up to monthly after four monthly loading doses, and patients randomized to aflibercept were dosed per its label. For Zenkuda, the primary endpoint was the change in visual acuity from baseline to the average of weeks 40, 44 and 48, RTTNews reported.

Longer intervals between injections are a central commercial argument for the company. Kodiak has said Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases, and Clinical Trial Vanguard put the global anti-VEGF market at roughly $26 billion in 2024. StocksToTrade reported that UBS had reiterated a Buy rating with an $80 price target before the results, on the view that both drugs would show non-inferiority to Eylea with potentially longer dosing intervals, and that Goldman Sachs had resumed coverage at Neutral with a $36 target. Before Monday, the stock had spent recent weeks in the low-to-mid $30s.

Kodiak laid out next steps in its announcement. It plans to submit a biologics license application, or BLA, for Zenkuda covering three indications in the fourth quarter of 2026. It has said the drug has a BLA-ready profile in diabetic retinopathy and retinal vein occlusion in addition to wet AMD. Kodiak also advanced tabirafusp-ted into the Phase 3 ALTO study, which is designed to test whether it is superior to aflibercept in diabetic macular edema and is now enrolling about 910 patients across two tabirafusp-ted dosing regimens and an aflibercept regimen. The company said it remains on track to report topline data in December 2026 from the Phase 3 PEAK study of KSI-101 in macular edema secondary to inflammation.

The company's finances show why the readout mattered. Kodiak had about $132.1 million in cash at June 30, down from $175.7 million, and reported a quarterly net loss of about $65.6 million, according to StocksToTrade, figures that are typical for a company funding late-stage trials but that leave it dependent on clinical progress. Stock Titan listed short interest at 10.8 million shares, or 18.1% of the float, in its latest reporting period.

Several caveats apply. The numbers so far are topline figures from the company's own press release, and full data will determine how the results compare with existing therapies. TOPONE Markets noted that details including the comparator arm's dosing frequency and the distribution of visual acuity outcomes are still needed to interpret the findings. Non-inferiority does not show a clinical advantage in vision, and durability results depend on the retreatment criteria used in the trial. No regulator has reviewed the data, and approval is not assured even if the company submits its application on schedule.

Even so, the reaction shows how much a single readout can reprice a clinical-stage biotech. Kodiak's shares had risen from the low $30s in the days before the announcement as investors positioned for the result, and Monday's move added to that gain. The company has an October presentation at the American Academy of Ophthalmology meeting, StocksToTrade reported, where more detail on the data could emerge.