Registered forecast
82% registered probability event by 2026-11-14 Unresolved
FDA approves the aficamten MAPLE-HCM supplement to NDA 219083 on or before the disclosed PDUFA goal date of 2026-11-14
FF-005 Registered - Registered probability
- 82%
- Event by
- 2026-11-14
- Resolution window
- 2026-09-27 → 2026-11-14
- Target rung
- 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-005/ registry snapshot 2026-10-06 Share image
NextConsensus registered this probability on 2026-09-26. It is one of 14 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on a supplement to NDA 219083 (aficamten, MYQORZO; applicant Cytokinetics) whose approved labeling includes the results of the MAPLE-HCM trial, with an approval action date on or before 2026-11-14, the PDUFA goal date disclosed in Cytokinetics' Form 10-Q filed 2026-08-06.
- 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
- Obstructive hypertrophic cardiomyopathy (MAPLE-HCM trial population)
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet.
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals.
An analyst reading the same public record on 2026-09-24 would weigh a positive randomized phase 3 trial, a drug already approved and sold, a standard-review supplement and a well-funded sponsor against the chance of a late labeling negotiation or an extension like the one on the original NDA. The analyst would call approval by the date likely. 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 clock
Dates that constrain the record
- Evidence cutoff
- 2026-09-26
Nothing after this date informed the estimate. - Registered
- 2026-09-26
Frozen and hashed. - Resolution window
- 2026-09-27 → 2026-11-14
When the adjudicator can read the outcome. - Event by
- 2026-11-14
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
a5cceddb217f50728de0be9b274908b92398542751b2c1e5f5aac2647294e93c · operator record jc-1790461082252-bcaed08e
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
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. 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 NDA219083 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219083%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2026-11-14 that is this supplement. The supplement number was not known at the cutoff, so it is identified by two fields read together: submission_class_code EFFICACY in openFDA, and a Drugs@FDA approval letter or approved label for that supplement that names MAPLE-HCM or describes a randomized trial comparing aficamten with metoprolol. If the approval letter names MAPLE-HCM but openFDA carries another class code, the letter governs. Approval with labeling language about MAPLE-HCM narrower than the applicant sought still resolves YES. Resolves NO if no such supplement is approved on or before 2026-11-14: 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 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28; if openFDA has not refreshed, the Drugs@FDA web record for NDA 219083 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. At the cutoff the record held ORIG 1, approved 2025-12-19, and SUPPL 1, approved 2026-02-05 with a class code other than EFFICACY (SRC-002), and the only approved label named neither MAPLE-HCM nor metoprolol (SRC-003). 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:%22NDA219083%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
- 82% 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 2026-09-26, including the one field whose value was unknown then. It is left unknown rather than filled in.
- review pathway
- standard review (SRC-001)
- submission type
- efficacy supplement to NDA 219083, asking to add trial results to the label of an approved new molecular entity (SRC-001, SRC-002)
- evidence class
- completed randomized, double-blind, active-comparator phase 3 trial, MAPLE-HCM (SRC-001)
- pivotal n
- unknown — not stated in the archived sources
- endpoint type
- change in peak oxygen uptake (pVO2) from baseline to week 24, aficamten against metoprolol (SRC-001)
- approved competitors in class
- not named in the archive — Cytokinetics describes MYQORZO as competing among cardiac myosin inhibitors in the United States (SRC-001)
- 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
- sNDA submitted January 2026, accepted for filing with standard review (SRC-001)
- odac referral
- none announced in the archived sources
- sponsor state change
- latest approved supplement to NDA 219083 is SUPPL 1, 2026-02-05, not an efficacy supplement (SRC-002); MYQORZO approved by the European Commission in February 2026 and in the United Kingdom in July 2026 (SRC-001)
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-09-26 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.
-
SRC-001Cytokinetics 10-Q for the quarter ended 2026-06-30, filed 2026-08-06. States that Cytokinetics submitted in January 2026, and FDA accepted for filing, a supplemental NDA for MYQORZO requesting to include in the label the results of MAPLE-HCM, a phase 3 randomized, double-blind, active-comparator trial of aficamten monotherapy against metoprolol monotherapy in obstructive HCM, with a standard review classification and a PDUFA date of November 14, 2026. States that MAPLE-HCM showed a statistically significant improvement in peak oxygen uptake from baseline to week 24 against metoprolol, that FDA approved MYQORZO in December 2025, and that the original NDA's PDUFA action date was extended once. -
SRC-002openFDA Drugs@FDA record for NDA219083 (MYQORZO, aficamten) retrieved at the cutoff. The starting state: ORIG 1 approved 2025-12-19 and SUPPL 1 approved 2026-02-05, whose submission_class_code is not EFFICACY; no efficacy supplement is approved. -
SRC-003Drugs@FDA prescribing information for MYQORZO approved with ORIG 1 (2025-12-19), the only label posted for NDA 219083 at the cutoff. Its clinical studies section describes SEQUOIA-HCM; it does not name MAPLE-HCM or metoprolol. This is what makes a label naming MAPLE-HCM a change an adjudicator can see.