KSI-501

Page updated October 13, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

KSI-501 is a Kodiak Sciences Inc. program. Every date links its source.

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Kodiak Sciences Inc. (KOD). Review status: Kodiak Sciences announced on September 28, 2026 that Zenkuda and tabirafusp-ted (KSI-501) met the primary endpoints in the pivotal DAYBREAK trial in wet AMD (8-K exhibit 99.1). We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

Readout · Sep 28, 2026 ✓ data reportedKOD

Specialist biotech funds holding KOD, 13F for the quarter ended June 30, 2026

Fund	Shares	Value at quarter end	Filing
Baker Bros. Advisors	19,919,186	$776.1 million	filed August 14, 2026
RTW Investments	1,487,934	$58.0 million	filed August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is KSI-501's next FDA decision or readout?

KSI-501's most recent tracked catalyst has already reported: positive data on Sep 28, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.

What happened at KSI-501's most recent FDA decision?

No FDA decision for KSI-501 is in our archive yet.

Who makes KSI-501?

Kodiak Sciences Inc. (KOD).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

About · Corrections · Methodology

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