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Kodiak eye drug matches Eylea in phase 3 trial after 2023 safety halt

Kodiak eye drug matches Eylea in phase 3 trial after 2023 safety halt

New Capabilities

Both candidates met primary endpoints in wet AMD; shares more than doubled and an FDA filing is planned for Q4 2026

Yesterday: DAYBREAK succeeds; stock more than doubles

Overview

Updated 1 hour ago

A drug Kodiak Sciences shelved in 2023 after a cataract safety signal is now on track for an FDA filing. The company reported Monday that both its experimental therapies for wet age-related macular degeneration met their primary endpoints against Regeneron's standard-of-care Eylea in the Phase 3 DAYBREAK trial.

Shares more than doubled, adding more than $3 billion to Kodiak's market value. The company plans to file for approval of its lead drug, Zenkuda, in the fourth quarter, citing five positive Phase 3 studies across three retinal diseases — and a key differentiating number: 54% of wet AMD patients in DAYBREAK went six months between doses under strict retreatment criteria.

Why it matters

If Zenkuda wins approval, wet AMD patients could space eye injections six months apart — a shift in treatment burden that could change the standard of care.

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Key Indicators

128%
stock jump on DAYBREAK readout
Kodiak shares rose from $32.35 at Friday's close to $72.99 at Monday's open.
$3B+
market value added
BioPharma Dive reported the readout added more than $3 billion to the company's market value.
54%
of Zenkuda patients on 6-month dosing
Majority of wet AMD patients achieved 24-week dosing intervals under strict real-world retreatment criteria.
5
positive phase 3 trials for Zenkuda filing
Across wAMD, diabetic retinopathy and retinal vein occlusion, per the planned biologics license application.

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Timeline

January 2023 September 2026

4 events Latest: Yesterday
Tap a bar to jump to that date
  1. DAYBREAK succeeds; stock more than doubles

    Latest Clinical Readout

    Zenkuda and tabirafusp-ted meet endpoints vs aflibercept; BLA planned for Q4.

  2. Four positive phase 3 studies on the books

    Milestone

    Quarterly filing lists GLOW1, GLOW2, BEACON and DAYLIGHT as successful; DAYBREAK is the remaining readout.

  3. Kodiak restarts Zenkuda program

    Decision

    Non-proliferative diabetic retinopathy data prompted resumption; renewed late-phase program begins.

  4. Kodiak halts Zenkuda development

    Setback

    Unexpected increase in cataracts in trials led to a temporary hold on the program.

Scenarios

1

FDA clears Zenkuda for wet AMD

Possible Resolves by Jan 31, 2028

Discussed by: Company guidance; FierceBiotech and Market Review describe the five positive trials as the evidence base

Kodiak files the multi-indication biologics license application in Q4 2026 covering five positive Phase 3 studies. The FDA completes a standard review and approves Zenkuda for at least one indication, validating the six-month dosing profile and opening a path to commercialization by late 2027 or early 2028.

2

FDA issues complete response letter on Zenkuda

Unlikely Resolves by Q2 2028

Discussed by: FierceBiotech notes the readout 'left unanswered questions' given the competitive field and the drug's cataract history

The cataract signal that halted Zenkuda in 2023 draws scrutiny during review, prompting the FDA to request additional safety data or an extra trial. Commercialization slides past the company's target window while Kodiak gathers more evidence.

3

Tabirafusp-ted wins its superiority trial in diabetic macular edema

Possible Resolves by End of 2027

Discussed by: Kodiak is accelerating the tabirafusp-ted program and actively enrolling the ALTO Phase 3 superiority study vs aflibercept in DME

The DAYBREAK pivot gives tabirafusp-ted a pivotal wet AMD result to build on. Success in ALTO would hand Kodiak a second brand with a differentiated mechanism — blocking both VEGF and the inflammatory cytokine IL-6 — and a path beyond wet AMD into diabetic macular edema.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1960s ban; 1998 and 2006 approvals

Thalidomide's second life — 1998 / 2006

Banned worldwide in the early 1960s after causing thousands of birth defects, thalidomide returned in 1998 to treat a form of leprosy and in 2006 for multiple myeloma, after researchers understood its anti-angiogenic and immune-modulating actions.

Then

The drug once seen as a public-health disaster became a therapy with tightly managed safety programs.

Now

Established a precedent that a therapy written off for a safety signal can be revived when new data change the risk-benefit calculus.

Why this matters now

Zenkuda traveled a similar arc from its 2023 cataract halt to five positive Phase 3 studies, though in the same indication rather than new ones.

January 2022 onward

Vabysmo (faricimab) launches — 2022

Roche's bispecific antibody, targeting both VEGF-A and Ang-2, won FDA approval for wet AMD and diabetic macular edema in January 2022. It competed with Eylea by offering dosing intervals up to every four months after loading, and became one of the fastest-growing ophthalmic drugs.

Then

Eylea faced its first serious branded challenger on dosing convenience, prompting Regeneron to respond with a higher-dose version, Eylea HD.

Now

Proved that dosing frequency is a decisive competitive lever in anti-VEGF therapy.

Why this matters now

Kodiak's 54% six-month durability extends the same convenience playbook Vabysmo used to take market share.

Mid-2020s

Aflibercept patent expiry and biosimilar entry — 2020s

Patents on Regeneron's Eylea have expired, opening the door to lower-priced biosimilars such as Biocon's Yesafili that now compete on cost.

Then

Price competition is compressing in anti-VEGF therapy.

Now

Branded developers must differentiate on dosing frequency and durability rather than price.

Why this matters now

Zenkuda's six-month dosing positions it to win on patient convenience in a market where biosimilars compete on cost.

Sources

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