pdufa.bio

Ifinatamab deruxtecan (I-DXd)

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

Ifinatamab deruxtecan (I-DXd) is a Merck & Co., Inc. program in extensive-stage small cell lung cancer. Every date links its source.

MRK catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Merck & Co., Inc. (MRK). Market-cap tier at the time we tracked it: Large. 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

Application withdrawn · Sep 25, 2026 Withdrawn before its Oct 10, 2026 goal dateMRK

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

FundSharesValue at quarter endFiling
OrbiMed Advisors663,400$85.2 millionfiled 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 Ifinatamab deruxtecan (I-DXd)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Ifinatamab deruxtecan (I-DXd); no FDA decisions are on record below.

What happened at Ifinatamab deruxtecan (I-DXd)'s most recent FDA decision?

No FDA decision for Ifinatamab deruxtecan (I-DXd) is in our archive yet.

Who makes Ifinatamab deruxtecan (I-DXd)?

Merck & Co., Inc. (MRK).

Where does this data come from?

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