Kodiak Sciences (NASDAQ:KOD) shares rose 31.9% in pre-market trading after the company released topline results from its DAYBREAK pivotal Phase 3 study evaluating two investigational therapies in patients with wet age-related macular degeneration.
The study evaluated Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer), with aflibercept serving as the active comparator.
Kodiak hosted a webcast at 8:30 a.m. Eastern Time to present the findings. The source material did not provide the specific efficacy or safety results from the study, so no conclusion about whether either therapy met the trial’s primary endpoint can be established from the information provided.
DAYBREAK Evaluates Two Investigational Therapies
The DAYBREAK study evaluates two separate drug candidates within the same Phase 3 trial, providing clinical data for both Zenkuda and KSI-501 in wet age-related macular degeneration.
Zenkuda has previously generated Phase 3 data in diabetic retinopathy and retinal vein occlusion. The DAYBREAK study provides additional data for the drug in wet age-related macular degeneration.
KSI-501, also known as tabirafusp alfa tedromer, is the second investigational therapy being evaluated in the DAYBREAK trial.
Analysts Had Expected Non-Inferiority Data
Ahead of the DAYBREAK results, UBS reiterated a Buy rating on Kodiak Sciences with an $80 price target. According to the source material, the firm expected tarcocimab to demonstrate non-inferiority and anticipated dosing intervals of approximately three to three-and-a-half months.
Another analyst maintained a Buy rating with a $58 price target as recently as mid-September.
These analyst forecasts preceded the release of the DAYBREAK topline results and represent their respective expectations rather than established clinical outcomes.
Kodiak Rises as Broader US Market Declines
Kodiak Sciences shares advanced in pre-market trading while major U.S. equity indexes moved lower. The Nasdaq declined 1.0%, the S&P 500 fell 0.6% and the Dow Jones was down 0.5%.
The company’s investigational therapies are being developed for retinal vascular diseases and would compete with existing treatments if they receive regulatory approval.
Kodiak shares moved toward their 52-week high of $47.84 following the DAYBREAK announcement. The stock has traded as low as $10.94 over the past 52 weeks.
Kodiak Sciences stock price