Kodiak Sciences said its Zenkuda and tabirafusp-ted drug candidates both met primary endpoints in the Phase 3 DAYBREAK study in wet age-related macular degeneration, advancing two late-stage programs toward additional regulatory and clinical milestones.
The company disclosed the results on Sept. 28 in an SEC filing and an accompanying release. Both investigational treatments achieved non-inferiority to aflibercept on the study’s year-one vision endpoint, while Kodiak said it plans to submit a biologics license application for Zenkuda in the fourth quarter of 2026 based on five positive Phase 3 studies.
Zenkuda, also known as tarcocimab tedromer, met its primary endpoint with a p-value of 0.0007. Kodiak said the treatment produced vision gains comparable to aflibercept while showing rapid retinal drying during the loading phase. At one year, 54% of Zenkuda-treated patients had reached a six-month dosing interval under the study’s treat-to-dryness retreatment criteria.
Kodiak reported a 0% rate of intraocular inflammation among Zenkuda-treated patients and a 0.5% cataract adverse-event rate, compared with 0.9% for the aflibercept comparator. The company described the safety findings as consistent with the established safety profile of aflibercept, although Zenkuda remains investigational and has not been approved for marketing.
Tabirafusp-ted, formerly designated KSI-501, also met its vision primary endpoint, with a p-value of 0.0036. The drug met an anatomical key secondary endpoint with a p-value below 0.0001. Kodiak reported intraocular inflammation in 0.4% of patients receiving tabirafusp-ted and no cataract adverse events, compared with a 0.9% cataract adverse-event rate for aflibercept.
DAYBREAK is a randomized Phase 3 study evaluating parallel investigational arms of Zenkuda and tabirafusp-ted against aflibercept in patients with treatment-naive wet AMD. Zenkuda was evaluated using individualized dosing intervals ranging from four to 24 weeks after four monthly loading doses, while tabirafusp-ted was administered on a fixed eight-week schedule with additional individualized dosing when needed.
The results give Kodiak a broader regulatory package for Zenkuda. The company said it has completed five positive Phase 3 studies involving Zenkuda, covering DAYBREAK and DAYLIGHT in wet AMD, GLOW1 and GLOW2 in diabetic retinopathy, and BEACON in macular edema following retinal vein occlusion. Kodiak plans to submit the Zenkuda data to regulators in the fourth quarter.
Tabirafusp-ted is moving into another late-stage test as well. Kodiak is enrolling patients in the Phase 3 ALTO study in diabetic macular edema, where the candidate is being evaluated for potential superiority over aflibercept. The company also plans post-hoc analyses of the DAYBREAK results to identify treatment-naive wet AMD patient subgroups that could potentially benefit from IL-6 inhibition.
The clinical milestones come as Kodiak continues to fund a costly late-stage development pipeline. Its second-quarter filing showed $125.9 million in cash and cash equivalents as of June 30, down from $209.9 million at the end of 2025. The company reported a $123.8 million net loss for the first six months of 2026, compared with a $111.8 million loss in the same period of 2025, while research and development expenses rose to $104.6 million from $86.4 million.
Kodiak said it has historically funded operations primarily through common-stock issuance and sales of future royalties. The company also said additional capital may be needed to maintain operations and continue research and development before its product candidates generate sufficient revenue.
Zenkuda and tabirafusp-ted remain investigational therapies, and the DAYBREAK results do not establish regulatory approval or guarantee that either candidate will ultimately reach the market. Kodiak’s planned fourth-quarter Zenkuda BLA submission and the continued development of tabirafusp-ted are subject to regulatory review, additional clinical data and other development risks.
