Bezuclastinib for Advanced systemic mastocytosis
The FDA is expected to decide on Bezuclastinib for Advanced systemic mastocytosis by June 29, 2027, under an NDA from Cogent Biosciences.
What is being decided
Cogent Biosciences has an NDA under FDA review for Bezuclastinib in Advanced systemic mastocytosis. Cogent's third bezuclastinib application, for the aggressive form of the disease. In the APEX trial, 65% of patients responded by mIWG criteria, with 79% progression-free at 12 months. The FDA said it does not plan an advisory committee.
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 Bezuclastinib?
The FDA's target date (PDUFA date) for Bezuclastinib in Advanced systemic mastocytosis is June 29, 2027.
Who disclosed it: Cogent Biosciences. 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: Cogent press release
What is Bezuclastinib being reviewed for?
Cogent Biosciences submitted an NDA for Bezuclastinib in Advanced systemic mastocytosis.
What to know: Cogent's third bezuclastinib application, for the aggressive form of the disease. In the APEX trial, 65% of patients responded by mIWG criteria, with 79% progression-free at 12 months. The FDA said it does not plan an advisory committee.
How much will Bezuclastinib cost?
Cogent Biosciences 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 Bezuclastinib 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 Cogent press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.