pdufa.bio

Lonvoguran ziclumeran (lonvo-z)

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

Lonvoguran ziclumeran (lonvo-z) is an Intellia Therapeutics, Inc. program in hereditary angioedema. Its PDUFA date is Mar 10, 2027, the FDA's goal date to complete review of the application. Every date links its source.

NTLA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Hereditary angioedema. Sponsor: Intellia Therapeutics, Inc. (NTLA). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 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

PDUFA · Mar 10, 2027NTLA

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

FundSharesValue at quarter endFiling
RA Capital Management4,526,926$76.6 millionfiled August 14, 2026
Baker Bros. Advisors930,232$15.7 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 Lonvoguran ziclumeran (lonvo-z)'s next FDA decision or readout?

Lonvoguran ziclumeran (lonvo-z)'s PDUFA date is Mar 10, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Lonvoguran ziclumeran (lonvo-z)'s most recent FDA decision?

No FDA decision for Lonvoguran ziclumeran (lonvo-z) is in our archive yet.

What is Lonvoguran ziclumeran (lonvo-z) used for?

In our records Lonvoguran ziclumeran (lonvo-z) is under review or in development for Hereditary angioedema.

Who makes Lonvoguran ziclumeran (lonvo-z)?

Intellia Therapeutics, Inc. (NTLA).

Where does this data come from?

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