Kodiak Sciences soars as Zenkuda, tabirafusp-ted hit primary endpoints in phase III wet AMD trial
Kodiak Sciences shares rose over 162% by midday Monday after two drug candidates, Zenkuda and tabirafusp-ted, met primary endpoints in the Phase III DAYBREAK trial for wet age-related macular degeneration. The therapies demonstrated statistical equivalence and non-inferiority to aflibercept. Zenkuda, also known as tarcocimab tedromer, showed vision gains and retinal drying with a p-value of 0.0007. Notably, 54% of patients in the trial reached a six-month dosing interval. The results have led to bullish analyst revisions and substantial insider buying, though some valuation risks persist.
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- ✓ Zenkuda and tabirafusp-ted met primary endpoints in the Phase III DAYBREAK trial for wet age-related macular degeneration.
- ✓ Zenkuda, also known as tarcocimab tedromer, achieved a p-value of 0.0007.
- ✓ Both therapies demonstrated non-inferiority and statistical equivalence to aflibercept.
- ✓ 54% of patients in the vision trial went six months between eye treatments.
What changed
Kodiak Sciences reported that Zenkuda and tabirafusp-ted met primary endpoints in the Phase III DAYBREAK study.
Live updates
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Kodiak Sciences stock surges after Phase III wet AMD trial success
Kodiak Sciences shares rose over 162% by midday Monday after two drug candidates, Zenkuda and tabirafusp-ted, met primary endpoints in the Phase III DAYBREAK trial for wet age-related macular degeneration. The therapies demonstrated statistical equivalence and non-inferiority to aflibercept. Zenkuda, also known as tarcocimab tedromer, showed vision gains and retinal drying with a p-value of 0.0007. Notably, 54% of patients in the trial reached a six-month dosing interval. The results have led to bullish analyst revisions and substantial insider buying, though some valuation risks persist.
Why it matters
Wet AMD is a retinal disease requiring frequent eye injections. Zenkuda and tabirafusp-ted are designed to compete with Eylea, the current market standard. Success in this trial allows the company to move toward a Biologics License Application filing.
What is confirmed
- Zenkuda and tabirafusp-ted met primary endpoints in the Phase III DAYBREAK trial for wet age-related macular degeneration.
- Zenkuda, also known as tarcocimab tedromer, achieved a p-value of 0.0007.
- Both therapies demonstrated non-inferiority and statistical equivalence to aflibercept.
- 54% of patients in the vision trial went six months between eye treatments.
- Kodiak Sciences shares increased by over 162% by midday Monday.
Still unconfirmed
- Kodiak Sciences targets a Q4 BLA filing.
- Martin Shkreli claims the results still suck.
What to watch next
- Submission of the Biologics License Application (BLA)
- FDA review and approval decision for Zenkuda and tabirafusp-ted
confidence 100%Sources used for this update (17)
- Forbes — Kodiak Sciences Up 150% At Opening Bell After Drugs Pass Key Trial
- Yahoo Finance — Kodiak Sciences soars as Zenkuda, tabirafusp-ted hit primary endpoints in phase III wet AMD trial
- FirstWord — Kodiak surges on Phase III victory for Eylea rival in wet AMD
- Yahoo Finance — KOD Stock Cracks September’s Top 5 Biotech Gainers On Eye Drug Win — But ‘Pharma Bro’ Shkreli Says It ‘Still Sucks’
- stocktitan.net — In a vision trial, 54% of patients went six months between eye treatments
- www.marketbeat.com — KOD News Today | Why did Kodiak Sciences stock go up today? $KOD
- finance.yahoo.com — Kodiak Sciences soars as Zenkuda, tabirafusp-ted hit primary ...
- www.prnewswire.com — Zenkuda and tabirafusp-ted Meet Primary Endpoints in Pivotal ...
- www.proactiveinvestors.com — Kodiak Sciences soars as Zenkuda, tabirafusp-ted hit primary ...
- allsci.com — Kodiak’s Zenkuda and tabirafusp-ted meet Phase III endpoints ...
- trial.medpath.com — Kodiak's Zenkuda and tabirafusp-ted hit primary endpoints in ...
- retinalphysician.com — DAYBREAK Meets Primary Endpoint in Wet AMD | Retinal Physician
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