Kodiak Sciences Inc.

Kodiak Sciences to Present Clinical Data Across All Three Late-Stage Programs at AAO 2026

Kodiak Sciences will present clinical data across all three of its late-stage assets—Zenkuda, tabirafusp-ted (KSI-501) and KSI-101—at AAO 2026 in New Orleans. The meeting includes the first scientific presentation of pivotal Phase 3 DAYBREAK results, which met their primary endpoint with both Zenkuda and tabirafusp-ted showing non-inferior vision gains versus aflibercept at Year 1. Phase 3 GLOW2 data for Zenkuda in diabetic retinopathy and Phase 1b APEX data for KSI-101 in MESI will also be presented. Zenkuda and KSI-501 target a $15 billion anti-VEGF market; KSI-101 topline PEAK data are expected in December 2026 with PEAK+PINNACLE in 2Q 2027.

•25d ago

Zenkuda and tabirafusp-ted Meet Primary Endpoints in Pivotal DAYBREAK Trial in wAMD, with Zenkuda Demonstrating a Potential New Standard-of-Care Profile with Strong Immediacy and Sustained Clinical Effect with Majority of Patients on 24-week Dosing Interval Using Strict Treat-to-Dryness Real World Retreatment Criteria.

Kodiak Sciences' Phase 3 DAYBREAK trial in wet AMD met primary endpoints for both Zenkuda (p=0.0007) and tabirafusp-ted (p=0.0036), with non-inferior vision gains versus aflibercept at one year. Zenkuda showed 54% of patients on 6-month dosing under strict treat-to-dryness retreatment criteria, with clean safety (0% intraocular inflammation). Kodiak plans a multi-indication BLA for Zenkuda in 4Q2026 across five positive Phase 3 studies in wAMD, diabetic retinopathy and RVO, with KSI-101 PEAK topline expected December 2026.

•1mo ago

Kodiak Sciences Announces First Patients Enrolled in Global Phase 3 ALTO trial of KSI-501 in Patients with Diabetic Macular Edema

Kodiak Sciences has enrolled the first patients in the global Phase 3 ALTO trial evaluating KSI-501 for diabetic macular edema. The study is designed to demonstrate the superiority of the bispecific therapy versus aflibercept and aims to enroll approximately 910 patients across three dosing arms. KSI-501 targets both IL-6 and VEGF pathways using Kodiak's ABC Platform, potentially offering extended durability with dosing intervals up to every six months.

•2mo ago

Kodiak Sciences Completes Enrollment in First Pivotal Cohort in the Phase 3 PEAK Trial of KSI-101 for Macular Edema Secondary to Inflammation and Reaffirms Topline Clinical Data Release Remains on Track for December 2026

Kodiak Sciences completed enrollment of the first 300-patient cohort in the Phase 3 PEAK trial of KSI-101 for macular edema secondary to inflammation (MESI). The company reaffirmed that topline clinical data from this pivotal cohort remains on track for release in December 2026, with the second pivotal cohort of 600 subjects expected to complete enrollment in the fourth quarter of 2026. KSI-101 is a bispecific protein targeting IL-6 and VEGF, designed to address the limitations of current systemic and ocular therapies by reducing inflammation and drying the retina.

•2mo ago

Kodiak Sciences Announces Recent Business Highlights and First Quarter 2026 Financial Results

Kodiak Sciences reported positive Phase 3 GLOW2 results for Zenkuda (tarcocimab tedromer) in diabetic retinopathy, demonstrating superiority over sham and supporting a multi-indication BLA submission. The company's pipeline advanced with enrollment complete in the DAYBREAK Phase 3 study for wet AMD and ongoing progress in the PEAK and PINNACLE studies for KSI-101. Financially, Kodiak ended Q1 2026 with $169.5 million in cash, sufficient to fund operations into 2027, and reported a net loss of $58.2 million.

•5mo ago

Kodiak Sciences to Present Pipeline Advances and KSI-101 Clinical Data, Including Results from a MESI Cohort in a Tertiary Care Uveitis Practice, at Upcoming Scientific Conferences

Kodiak Sciences announced that KSI-101 data from an Asian tertiary care uveitis cohort demonstrated outcomes consistent with the U.S. Phase 1b APEX study, supporting global expansion of Phase 3 programs. In the Asian cohort, 58% of patients achieved a ≥15-letter gain in BCVA with a mean increase of +17.8 letters at Week 24, and central subfield thickness was reduced to <325 µm after a single injection. The company also highlighted progress across its pipeline, including bispecific therapies for geographic atrophy and the ABCD platform for high DAR drug delivery, with Zenkuda topline data expected in 3Q 2026.

•6mo ago