FDA approves bezuclastinib for nonadvanced systemic mastocytosis on or before the disclosed PDUFA goal date of 2026-12-30

The proposition

What was claimed

The FDA takes an approval action on Cogent Biosciences' New Drug Application for bezuclastinib for the treatment of patients with nonadvanced systemic mastocytosis, with an approval action date on or before 2026-12-30, the PDUFA date disclosed in Exhibit 99.1 to Cogent Biosciences' Form 8-K filed 2026-08-10.

Authority

US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)

Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung

Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.

Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates

FDA action by goal date

Scope

Nonadvanced systemic mastocytosis

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-10-15 Registered2026-10-15 Window opens2026-10-16 Deadline2026-12-30

Evidence cutoff

2026-10-15

Registered

2026-10-15

Window opens

2026-10-16

Deadline

2026-12-30

Evidence cutoff

2026-10-15
Nothing after this date informed the estimate.

Registered

2026-10-15
Frozen and hashed.

Resolution window

2026-10-16 → 2026-12-30
When the adjudicator can read the outcome.

Event by

2026-12-30
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger ee048aedc9382c734fe3af3f5a44247c1270bba9983104a3991026af98262a61 Copy · operator record jc-1792036247689-1020905b

Resolution

The rule that settles the forecast

Cogent has separate bezuclastinib applications for gastrointestinal stromal tumour, with an earlier goal date (SRC-001), and for advanced systemic mastocytosis (SRC-002), so this approval is identified by its indication, not by being the first bezuclastinib approval; an approval only for GIST or advanced systemic mastocytosis does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a second application), contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-12-30, and the Drugs@FDA approval letter or label for that submission names nonadvanced systemic mastocytosis (or indolent or smoldering systemic mastocytosis) in its indication. An approval for indolent systemic mastocytosis only, or another narrower nonadvanced population, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-30: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-30 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-13. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name bezuclastinib) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.

Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bezuclastinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22BEZUCLASTINIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/

Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.

What this record will show once it resolves

Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff

The state of the record at the cutoff

Recorded as they stood on 2026-10-15.

review pathway

Not stated for the NonAdvSM NDA in the archived sources (the separate GIST NDA is stated to be under Priority Review/RTOR, SRC-002). Submitted December 2025 with PDUFA December 30, 2026 (SRC-002): a ~12-month timeline is consistent with a standard review of a new molecular entity (drafter's understanding, unverified).

submission type

Original NDA (SRC-002).

evidence class

Registration-directed randomized, double-blind, placebo-controlled Phase 2 SUMMIT (Part 2) (SRC-002, SRC-005).

pivotal n

SUMMIT Part 2: 118 bezuclastinib + 60 placebo (SRC-005).

endpoint type

Patient-reported symptom score: mean change in total symptom score (TSS, Mastocytosis Symptom Severity Daily Diary) at 24 weeks (SRC-005).

approved competitors in class

Blueprint Medicines' (a Sanofi company) avapritinib is approved for Non-AdvSM; avapritinib and midostaurin approved for AdvSM (SRC-004).

months since last guideline revision

not applicable — no guideline is the subject of this proposition

panel cycle position

not applicable — the act is an FDA approval action

sponsor request status

NDA for NonAdvSM submitted December 2025, accepted March 2026 (SRC-002).

odac referral

none announced in the archived sources

sponsor state change

None reported. Cogent signed a commercial supply agreement with Hovione for bezuclastinib on September 1, 2026 (SRC-006).