Registered forecast
80% registered probability event by 2027-02-04 Unresolved
FDA approves oral infigratinib for children with achondroplasia on or before the disclosed PDUFA goal date of 2027-02-04
FF-044 Registered - Registered probability
- 80%
- Event by
- 2027-02-04
- Resolution window
- 2026-10-16 → 2027-02-04
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 80%
nextconsensus.com/forecast/ff-044/ registry snapshot 2026-10-15 Share image
NextConsensus registered this probability on 2026-10-15. It is one of 26 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on BridgeBio Pharma's New Drug Application for oral infigratinib for the treatment of children with achondroplasia, with an approval action date on or before 2027-02-04, the PDUFA target action date disclosed in Exhibit 99.1 to BridgeBio's Form 8-K filed 2026-10-13.
- 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
- Achondroplasia in children, oral
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. Original NDAs under Priority Review with a positive phase 3 trial are approved at their first goal date in a large majority of cases. 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 actions on original NDAs are approvals. With no evidence input it cannot tell a strong application from a weak one.
An analyst reading the same filings on 2026-10-13 would weigh a phase 3 trial that met its primary and key secondary endpoints, Priority Review and Breakthrough Therapy designation against a first approval of an oral FGFR3 inhibitor for long-term use in children, with no statement on an advisory committee. 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
- 2026-10-15
Nothing after this date informed the estimate. - Registered
- 2026-10-15
Frozen and hashed. - Resolution window
- 2026-10-16 → 2027-02-04
When the adjudicator can read the outcome. - Event by
- 2027-02-04
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
1538844d949089accb6f028165bb4a479dbb648525433afaeaa75602daa91b16 · operator record jc-1792036449913-beb21bb5
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
The application number was not public at the cutoff, and the ingredient already has an approval that is not this one: openFDA lists NDA214622 (TRUSELTIQ, infigratinib phosphate, applicant Helsinn Healthcare, both strengths discontinued), whose ORIG-1 was approved 2021-05-28 for an oncology indication (SRC-005). That approval does not count. The adjudicator identifies the qualifying approval by its indication plus its ingredient, never by a name the adjudicator infers: an approval action whose Drugs@FDA approval letter or label names achondroplasia in its indication, for a product whose active ingredient is infigratinib or a salt of it (infigratinib phosphate, for example), under any applicant (BridgeBio Pharma, its subsidiary QED Therapeutics, or another BridgeBio subsidiary) and any proprietary name. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22infigratinib%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain such an approval: an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2027-02-04, or, if FDA acts on the achondroplasia indication as a supplement to an existing infigratinib application, an efficacy supplement with submission_status AP and a submission_status_date on or before 2027-02-04 whose letter or label adds achondroplasia. An approval for a narrower achondroplasia population than the applicant sought (by age, for example) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2027-02-04: 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 2027-02-04 resolves NO as occurred_after_deadline. 2027-02-04 is a Thursday. Read no earlier than 2027-02-18. If openFDA has not refreshed by then, or both queries return nothing new, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name infigratinib) governs, under the same identification test. 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:%22infigratinib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22INFIGRATINIB%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
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
- 80% 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 2026-10-15, including the one field whose value was unknown then. It is left unknown rather than filled in.
- review pathway
- Priority Review (SRC-001). Breakthrough Therapy, Orphan Drug, Fast Track and Rare Pediatric Disease designations (SRC-001). Center CDER is the drafter's understanding (a small-molecule NDA), unverified.
- submission type
- NDA for oral infigratinib in achondroplasia (SRC-001, SRC-004); application number not public. The ingredient was approved in 2021 under NDA214622 (TRUSELTIQ, Helsinn Healthcare, discontinued) for another indication (SRC-005).
- evidence class
- Placebo-controlled phase 3 trial, PROPEL 3, at 52 weeks; supported by the phase 2 PROPEL 2 trial, on which the Breakthrough Therapy designation rests (SRC-001).
- pivotal n
- unknown — not stated in the archived sources
- endpoint type
- Clinical growth measure: change from baseline in annualized height velocity at Week 52 (primary) and height Z-score (key secondary) (SRC-001).
- approved competitors in class
- BridgeBio states infigratinib would be "the first and only approved oral therapy" for children with achondroplasia (SRC-001); the archived sources do not name the approved non-oral therapy.
- 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 submitted by 2026-08-10 (SRC-003, SRC-004); FDA acceptance with Priority Review announced 2026-10-06 (SRC-001, SRC-002).
- odac referral
- none announced in the archived sources
- sponsor state change
- none recorded in the archived sources since NDA submission
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-10-15 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-001BridgeBio Form 8-K Exhibit 99.1, filed 2026-10-13: press release dated 2026-10-06. FDA accepted for filing the NDA for oral infigratinib for children with achondroplasia, with Priority Review and a PDUFA target action date of February 4, 2027; PROPEL 3 primary and key secondary endpoints met; Breakthrough Therapy, Orphan Drug, Fast Track and Rare Pediatric Disease designations. -
SRC-002BridgeBio Form 8-K (Item 8.01), filed 2026-10-13, date of report 2026-10-06: attaches the press release on FDA acceptance and Priority Review of the oral infigratinib NDA as Exhibit 99.1. -
SRC-003BridgeBio Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-10. States the oral infigratinib NDA for achondroplasia has been submitted, U.S. launch expected mid-2027, an MAA planned for Q4 2026, and 720.2 million dollars in cash, cash equivalents and marketable securities at 2026-06-30. -
SRC-004BridgeBio Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-10. States the NDA for low-dose infigratinib for achondroplasia was submitted to FDA; infigratinib is held through the subsidiary QED Therapeutics; Kyowa Kirin licence for Japan. -
SRC-005openFDA drugsfda products.active_ingredients.name:"INFIGRATINIB", retrieved 2026-10-13: one application, NDA214622 (TRUSELTIQ, infigratinib phosphate, applicant Helsinn Healthcare, both strengths Discontinued), ORIG-1 approved 2021-05-28. No application for achondroplasia. -
SRC-006openFDA drugsfda openfda.generic_name:"infigratinib", retrieved 2026-10-13: 404 No matches found.