Kodiak Sciences' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kodiak Sciences (KOD).
Over the past two years, Kodiak Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
tarcocimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Tarcocimab tedromer FDA Regulatory Events
Tarcocimab tedromer is a drug developed by Kodiak Sciences for the following indication: In patients with diabetic retinopathy ("DR").
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tarcocimab tedromer
- Announced Date:
- March 10, 2025
- Indication:
- In patients with diabetic retinopathy ("DR").
Announcement
Kodiak Sciences Inc. announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ("DR").
AI Summary
Kodiak Sciences Inc. announced that it has successfully completed enrollment for its GLOW2 Phase 3 clinical trial, which is evaluating tarcocimab tedromer in patients with diabetic retinopathy. The trial enrolled over 250 patients, surpassing its initial target. The GLOW2 study closely mirrors the design of the successful GLOW1 trial, with the added benefit of an extra loading dose, providing more dosing flexibility for healthcare providers. With a 48‐week treatment period, all patients are expected to complete their primary endpoint visits by the end of January 2026. Kodiak plans to announce the topline clinical data from GLOW2 in the first quarter of 2026, a step that could support the regulatory filing of tarcocimab if the outcomes continue to show promise in treating diabetic retinopathy.
Read Announcement
Kodiak Sciences FDA Events - Frequently Asked Questions
As of now, Kodiak Sciences (KOD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Kodiak Sciences (KOD) has reported FDA regulatory activity for tarcocimab tedromer.
The most recent FDA-related event for Kodiak Sciences occurred on March 10, 2025, involving tarcocimab tedromer. The update was categorized as "Enrollment Update," with the company reporting: "Kodiak Sciences Inc. announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ("DR")."
Currently, Kodiak Sciences has one therapy (tarcocimab tedromer) targeting the following condition: In patients with diabetic retinopathy ("DR")..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:KOD) was last updated on 7/14/2025 by MarketBeat.com Staff
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