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Kodiak Sciences Inc. (KOD) filed an 8-K current report with the SEC on September 28, 2026 reporting Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Positive Phase 3 DAYBREAK results for Zenkuda and tabirafusp-ted in wet age-related macular degeneration.
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Item 8.01 · Other Events
- Positive Phase 3 DAYBREAK results for Zenkuda and tabirafusp-ted in wet age-related macular degeneration
- Primary endpoints met for both investigational therapies, supporting potential regulatory submissions
- Results could strengthen Kodiak’s competitive position in wet AMD and advance pipeline commercialization prospects
- Exhibit 99.1 contains detailed efficacy, safety, and study results for investor review
Item EX-99.1 · Exhibit EX-99.1
- Zenkuda met DAYBREAK’s primary endpoint with p=0.0007, showing non-inferior vision gains versus aflibercept in wAMD
- 54% of Zenkuda patients reached 24-week dosing at year one under strict treat-to-dryness criteria, supporting differentiated durability
- Favorable safety profile: 0% intraocular inflammation and 0.5% cataract adverse events versus 0.9% for aflibercept
- Multi-indication Zenkuda BLA planned for 4Q2026, covering five positive Phase 3 studies across wAMD, DR and RVO
- Tabirafusp-ted met vision and anatomical endpoints with p=0.0036 and p<0.0001, while Phase 3 ALTO enrollment advances in DME
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