pdufa.bio

Darovasertib

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

Darovasertib is an IDEAYA Biosciences, Inc. program. Its next catalyst is a Readout in Jan 2027. Every date links its source.

IDYA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: IDEAYA Biosciences, Inc. (IDYA). We track 2 catalyst events for this program: 2 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

Readout · Jan 2027IDYAReadout · Apr 2027IDYA

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

FundSharesValue at quarter endFiling
Baker Bros. Advisors5,010,030$186.7 millionfiled August 14, 2026
Redmile Group640,202$23.9 millionfiled August 14, 2026
RTW Investments370,370$13.8 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 Darovasertib's next FDA decision or readout?

The next tracked catalyst for Darovasertib is a Readout in Jan 2027.

What happened at Darovasertib's most recent FDA decision?

No FDA decision for Darovasertib is in our archive yet.

Who makes Darovasertib?

IDEAYA Biosciences, Inc. (IDYA).

Where does this data come from?

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