Registered forecast
85% registered probability event by 2027-02-18 Unresolved
FDA approves the VYVGART (efgartigimod alfa) supplement extending the generalized myasthenia gravis indication to pediatric patients on or before the disclosed PDUFA goal date of 2027-02-18
FF-057 Registered - Registered probability
- 85%
- Decision by
- 2027-02-18
- Reading window
- 2026-11-02 → 2027-02-18
- Decision stage
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 85%
nextconsensus.com/forecast/ff-057/ registry snapshot 2026-11-01 Share image
NextConsensus registered this probability on 2026-11-01. It is one of 29 registered FDA goal-date forecasts.
The proposition
What was registered
The FDA takes an approval action on a supplement to BLA 761195 (efgartigimod alfa-fcab, VYVGART; applicant argenx BV) or to BLA 761304 (efgartigimod alfa and hyaluronidase-qvfc, VYVGART HYTRULO; applicant argenx BV) whose approved labeling extends the generalized myasthenia gravis indication to patients younger than 18 years, with an approval action date on or before 2027-02-18, the PDUFA date disclosed in Exhibit 99.2 to argenx’s Form 6-K furnished 2026-10-22, for the pediatric gMG sBLA that Exhibit 99.1 to the same 6-K says FDA accepted for priority review.
- Who decides
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Decision stageThe kind of body that has to act: a guideline panel, a regulator, or a payer. 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.
- Decision typeThe type of decision this forecast is counted with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- Generalized myasthenia gravis in patients younger than 18 years
The estimate
The number and the baselines it has to beat
The estimate that the named body takes the action by the deadline, from what was public at the cutoff.
The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements that extend an approved product to a pediatric population are approved at their first goal date more often than original applications. The calendar’s own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1).
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. With no evidence input it cannot tell a strong application from a weak one.
An analyst reading the same filings on 2026-10-27 would weigh priority review, five years of adult use, and adolescent results consistent with adults, against an open-label dosing study with a younger cohort still enrolling in April 2026. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The method and every record are public, so you can check the work.
The clock
Dates that constrain the record
- Evidence as of
- 2026-11-01
Nothing after this date informed the estimate. - Registered
- 2026-11-01
Frozen and hashed. - Reading window
- 2026-11-02 → 2027-02-18
When the outcome can be read against the rule. - Event by
- 2027-02-18
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
5e18d5ba98a42de80bc1981b7c88460b4cb2f13814b914581fecb1a1613a6589 · operator record jc-1793551264342-b66e2401 Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Evaluating a claim that the FDA could change?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. The stake need not be ownership — a claim you evaluate, finance, advise on, or rely upon is enough. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Resolves YES if the openFDA Drugs@FDA record for application BLA761195 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22BLA761195%22) or for application BLA761304 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22BLA761304%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-02-18, and the Drugs@FDA approval letter or the label approved with it extends the generalized myasthenia gravis indication in the INDICATIONS AND USAGE section to pediatric patients (patients younger than 18 years, in any age range). argenx disclosed one sBLA covering both products (SRC-001); an approval on either application is enough, and the two are one instance on one goal date. The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplements were SUPPL 16 to BLA761195 and SUPPL 18 to BLA761304, both approved 2026-05-08, which extended the indication to all adult patients with gMG and are not this supplement (SRC-004, SRC-005, SRC-006). An approval for a narrower pediatric population than submitted (adolescents only, for example, or one of the two products only) still resolves YES. A supplement for ocular myasthenia gravis, IMNM or any other indication does not count. Resolves NO if no qualifying approval action is dated on or before 2027-02-18: 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 a qualifying approval dated after 2027-02-18 resolves NO as occurred_after_deadline. 2027-02-18 is a Thursday. Read no earlier than 2027-03-04; if openFDA has not refreshed, the Drugs@FDA web records for BLA761195 and BLA761304 (https://www.accessdata.fda.gov/scripts/cder/daf/) govern. Resolves unresolvable only if neither source 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=application_number:%22BLA761195%22, https://api.fda.gov/drug/drugsfda.json?search=application_number:%22BLA761304%22, 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
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 85% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
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 2026-11-01, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in.
- review pathway
- Priority review (SRC-001). Center CDER (both BLAs listed in openFDA drugsfda, SRC-005, SRC-006).
- submission type
- Supplemental BLA (efficacy; new pediatric population) to BLA 761195, VYVGART, and BLA 761304, VYVGART HYTRULO, disclosed as one sBLA (SRC-001, SRC-005, SRC-006).
- evidence class
- One open-label study, ADAPT Jr, in children and adolescents with AChR antibody positive gMG, with dosing confirmation as its primary objective; results reported for adolescents aged 12 to 17, and a younger cohort enrolling as of April 2026 (SRC-003).
- pivotal n
- unknown — not stated in the archived sources
- endpoint type
- Pharmacokinetic (primary objective: confirm age-appropriate dosing), with safety, immunogenicity and clinical effect on MG-ADL and QMG as secondary or key assessments (SRC-003).
- approved competitors in class
- unknown — the archived sources name no therapy approved for pediatric gMG
- 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
- sBLA accepted for priority review, announced 2026-10-22, PDUFA date 2027-02-18 (SRC-001, SRC-002). The latest approved supplements on both applications at the cutoff were the all-adult gMG efficacy supplements of 2026-05-08 (SRC-004, SRC-005, SRC-006).
- odac referral
- none announced in the archived sources
- sponsor state change
- none bearing on the application recorded in the archived sources; argenx reported USD 1.7 billion in global product net sales for Q3 2026 (SRC-001).
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-11-01 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
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SRC-001argenx Form 6-K Exhibit 99.1, furnished 2026-10-22: Q3 2026 results release. The sBLA for VYVGART and VYVGART Hytrulo in pediatric gMG was accepted for priority review by FDA, with a PDUFA target action date in February 2027; an sBLA for VYVGART in ocular MG was submitted; an sBLA for VYVGART Hytrulo in IMNM is on track for submission by year-end 2026. -
SRC-002argenx Form 6-K Exhibit 99.2, furnished 2026-10-22: Q3 2026 results presentation. Slide 4 lists efgartigimod programs in four columns (Pediatric gMG, IMNM, Ocular MG, Autoinjector) with, in the same order, 'PDUFA date of February 18, 2027', 'sBLA on track for submission by YE', 'sBLA submitted' and 'Potential launch in 2H 2027'. -
SRC-003argenx Form 6-K Exhibit 99.1, furnished 2026-04-20: AAN 2026 data release. ADAPT Jr results in adolescents aged 12 to 17 with AChR antibody positive gMG showed consistent and repeatable MG-ADL improvements across treatment cycles; enrollment of a younger pediatric cohort was ongoing; the study's primary objective is to confirm age-appropriate dosing. -
SRC-004argenx Form 6-K Exhibit 99.1, furnished 2026-05-11: FDA approval expanding VYVGART and VYVGART Hytrulo to all adult patients with gMG; argenx states it is advancing VYVGART for pediatric gMG in the ADAPT Jr study. -
SRC-005openFDA drugsfda application_number:"BLA761195", retrieved 2026-10-27: VYVGART (efgartigimod alfa-fcab), applicant argenx BV; ORIG-1 approved 2021-12-17; efficacy supplements SUPPL 4 (2024-08-08), 12 (2025-10-17) and 16 (2026-05-08). No approval after 2026-05-08. -
SRC-006openFDA drugsfda application_number:"BLA761304", retrieved 2026-10-27: VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), applicant argenx BV; latest efficacy supplement SUPPL 18 approved 2026-05-08; labeling SUPPL 19 approved 2026-02-26. No approval after 2026-05-08.