Varegacestat for Desmoid tumors
The FDA is expected to decide on Varegacestat for Desmoid tumors by April 28, 2027, under an NDA from Immunome.
What is being decided
Immunome has an NDA under FDA review for Varegacestat in Desmoid tumors. Gamma secretase inhibitor for rare, locally aggressive soft-tissue tumors.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Varegacestat?
The FDA's target date (PDUFA date) for Varegacestat in Desmoid tumors is April 28, 2027.
Who disclosed it: Immunome. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Immunome announcement
What is Varegacestat being reviewed for?
Immunome submitted an NDA for Varegacestat in Desmoid tumors.
What to know: Gamma secretase inhibitor for rare, locally aggressive soft-tissue tumors.
How much will Varegacestat cost?
Immunome has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Varegacestat decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Immunome announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.