Kodiak Sciences Inc ( KOD ) shares are trading higher Friday morning after the company announced positive topline results from its Phase 3 GLOW2 study for Zenkuda in diabetic retinopathy, hitting a new 52-week high in early trading.

Investors appear to be responding to both the strength of the data and the possibility of a faster path toward a biologics license application, or BLA. Here’s what investors need to know.

Kodiak Sciences ( KOD ) stock is challenging resistance. Why are KOD shares at highs?

Zenkuda Hits Primary, Secondary Endpoints In GLOW2

In the GLOW2 study, 62.5% of Zenkuda-treated patients achieved at least a two-step improvement in Diabetic Retinopathy Severity Scale, or DRSS, scores, compared with just 3.3% in the sham group.

The company also said Zenkuda reduced the risk of sight-threatening complications by 85%, with 2.4% of treated patients experiencing those events versus 15.8% in the sham arm. A separate secondary endpoint showed 13.7% of treated patients achieved at least a three-step DRSS improvement, compared with 0% for sham.

Kodiak Highlights Safety Profile, Faster BLA Timeline

Kodiak said Zenkuda was well tolerated, with no reported cases of intraocular inflammation and a low cataract adverse event rate. Management said the results give Zenkuda a multi-indication BLA-ready profile and that it intends to accelerate the submission timeline.

KOD Shares Surge Friday Morning

KOD Price Action: Kodiak Sciences ( KOD ) shares were up 13.68% at $45.20 at the time of publication on Friday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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