pdufa.bio

Litifilimab

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

Litifilimab is a Biogen Inc. program. Every date links its source.

BIIB catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Biogen Inc. (BIIB). We track 2 catalyst events for this program: 0 upcoming and 2 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 2026BIIBReadout · Oct 2026BIIB

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

FundSharesValue at quarter endFiling
Perceptive Advisors276,173$59.7 millionfiled August 14, 2026
OrbiMed Advisors61,600$13.3 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 Litifilimab's next FDA decision or readout?

No upcoming catalyst is on our calendar for Litifilimab; no FDA decisions are on record below.

What happened at Litifilimab's most recent FDA decision?

No FDA decision for Litifilimab is in our archive yet.

Who makes Litifilimab?

Biogen Inc. (BIIB).

Where does this data come from?

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